A Phase Ib/II Study to Evaluate the Safety and Efficacy of Enfortumab Vedotin Plus Pembrolizumab in Combination With Quemliclustat in Unresectable Locally Advanced and Metastatic Urothelial Carcinoma

This phase Ib/II trial tests the safety, side effects, and best dose of quemliclustat in combination with enfortumab vedotin and pembrolizumab, and to see how well the combination works for the treatment of bladder, renal pelvis, or ureter urothelial cancer that cannot be removed by surgery (unresectable), that has spread to nearby tissue or lymph nodes (locally advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). Enfortumab vedotin is a monoclonal antibody, enfortumab, linked to an anticancer drug called vedotin. It works by helping the immune system to slow or stop the growth of cancer cells. Enfortumab attaches to a protein called nectin-4 on cancer cells in a targeted way and delivers vedotin to kill them. It is a type of antibody-drug conjugate. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Quemliclustat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving quemliclustat in combination with enfortumab vedotin and pembrolizumab and may be safe, tolerable and/or effective in treating patients with unresectable locally advanced and metastatic urothelial cancer.

Start Date01 Dec 2026

Sponsor / Collaborator

Fred Hutchinson Cancer Center

[+1]

NCT07643519

/ Not yet recruitingPhase 2IIT

Neoadjuvant Enfortumab Vedotin Plus Pembrolizumab in Muscle-Invasive Bladder Cancer and Upper Tract Urothelial Carcinoma

Radical cystectomy remains the standard curative-intent treatment for most patients with muscle-invasive bladder cancer, but it is associated with significant morbidity and long-term quality-of-life implications. Trimodality therapy is an accepted standard-of-care alternative for carefully selected patients who wish to preserve their bladder; however, optimal patient selection remains challenging.
The combination of enfortumab vedotin plus pembrolizumab (EV-P) has demonstrated remarkable activity in urothelial carcinoma, including in the perioperative setting, with pathologic complete response rates of approximately 50-60%. These results generate the hypothesis that a subset of patients may achieve sufficiently deep responses to allow selective deferral of cystectomy. Cohort A of this trial prospectively evaluates the use of multimodal response assessment (pelvic MRI and TURBT, ctDNA) to guide individualized decisions regarding cystectomy versus bladder preservation.
Radical nephroureterectomy (RNU) remains the standard curative-intent treatment for high-risk upper tract urothelial carcinoma (UTUC), but recurrence rates after surgery alone are high. Neoadjuvant cisplatin-based chemotherapy improves pathologic outcomes and is supported by phase II data, but its delivery is constrained by baseline renal dysfunction and the further decline in glomerular filtration that follows RNU - historically, only about 20% of patients remain cisplatin-eligible postoperatively, which is the principal rationale for delivering platinum in the neoadjuvant rather than adjuvant setting. A large fraction of patients with UTUC are cisplatin-ineligible at baseline, and no level 1 evidence supports a specific neoadjuvant regimen in this population.
EV-P is not constrained by renal function and has produced unprecedented activity in urothelial carcinoma. In the EV-302 upper tract subgroup, EV-P achieved an objective response rate of 67.7% and a complete response rate of 28.6%, with survival benefit preserved relative to platinum-based chemotherapy. In the perioperative bladder cancer setting, EV-P has yielded pathologic complete response rates of approximately 50-60%. However, available data on EV-P in UTUC are restricted to the metastatic setting, and prospective evaluation in the neoadjuvant setting is lacking. Cohort B of this trial addresses this gap by prospectively evaluating neoadjuvant EV-P followed by RNU in patients with high-risk UTUC, with pathologic complete response as the primary endpoint.

Start Date01 Dec 2026

Sponsor / Collaborator

University of Florida

NCT07822373

/ Not yet recruitingPhase 2IIT

PRESERVE: A Phase 2 Study Evaluating Bladder Preservation With Enfortumab Vedotin Plus Pembrolizumab in Patients With Muscle-Invasive Urothelial Cancer

The purpose of this study is to evaluate whether Enfortumab Vedotin in combination with Pembrolizumab can achieve a clinical response that preserves the bladder and avoids the need for cystectomy or radiation therapy in patients with urothelial cancer.

Start Date01 Nov 2026

Sponsor / Collaborator

University of Utah

100 Clinical Results associated with Enfortumab Vedotin-ejfv

100 Translational Medicine associated with Enfortumab Vedotin-ejfv

100 Patents (Medical) associated with Enfortumab Vedotin-ejfv

1,229

Literatures (Medical) associated with Enfortumab Vedotin-ejfv

01 Oct 2026·CANCER LETTERS

Antibody-drug conjugates against multidrug-resistant cancers: Biomarker-guided patient selection, payload engineering, linker chemistry, and bystander effects

Review

Author: Chen, Zhe-Sheng ; Huang, Qinguo ; Chen, Xiang ; Ling, Hongjian ; Li, Ryan ; Gong, Kunxiang

Antibody-drug conjugates (ADCs) are one of the most significant advancements in modern cancer therapeutics. Combining the target selectivity of monoclonal antibodies with the cytotoxic potential of payloads, ADCs effectively kill cancer cells and offer hope to patients with even refractory cancer types. Beyond simply increasing the number of therapeutic options available for cancer patients, ADCs have become a powerful frontline agent in overcoming multidrug resistance (MDR). As one of the most challenging obstacles to effective cancer care, MDR is mediated by ATP-binding cassette (ABC) transporter-mediated drug efflux, target-based mutations, and dysregulated apoptosis. The clinical success of ADCs specifically engineered to overcome MDR, including in heterogeneous tumors and cancer cells that exhibit bypass signaling, is well established. This is especially evident with trastuzumab deruxtecan (T-DXd) in HER2-low, HER2-positive, and HER2-mutant cancers; sacituzumab govitecan (SG) in TROP2-expressing triple-negative breast cancer (TNBC) and urothelial carcinoma; and enfortumab vedotin in Nectin-4-positive bladder cancer. By overcoming MDR, ADCs have enabled more effective treatment algorithms across multiple malignancies. Most importantly, the clinical application of ADCs has become inextricably linked to cancer genomics. HER2 testing has evolved from a two-tiered system to a continuous spectrum including HER2-ultralow, HER2-low, HER2-positive, and ERBB2-mutant categories. Each of these categories exhibits different eligibility guidelines for ADC patient selection. As cancer cells continue to evolve and develop resistance to even ADCs through mutations and variants, researchers and clinicians have used pharmacogenomics to predict ADC response and resistance. To define the genomic architecture of ADC-resistant tumor subpopulations, single-cell transcriptomic studies and liquid biopsy approaches are being used to enable real-time examination of the tumor genome during ADC therapy, thereby optimizing treatment and circumventing resistance driven by emerging mutations and variants. This review provides a comprehensive analysis of the molecular structure of ADCs, the pharmacological principles underlying their potent cytotoxic activity against MDR cancer cells, the genomic and transcriptomic biomarkers that guide ADC patient selection, and the emerging resistance mechanisms that will shape the next generation of promising ADC development.

01 Sep 2026·Clinical Genitourinary Cancer

Baseline Sarcopenia is Associated With Overall Survival but Not Toxicity in Patients Receiving Enfortumab Vedotin Plus Pembrolizumab for Locally Advanced or Metastatic Urothelial Carcinoma

Article

Author: Enzinger, Benazir ; Aydogdu, Can ; Semmler, Marie ; John, Benso ; Stief, Christian G ; Kolligs, Frederik ; Berg, Elena K ; Brinkmann, Isabel ; Hahn, Simon ; Fischer, Judith ; Casuscelli, Jozefina

BACKGROUND:

Enfortumab vedotin plus pembrolizumab (EV/P) is the first-line standard for locally advanced or metastatic urothelial carcinoma (la/mUC). Sarcopenia is common in this population and may affect outcomes, but its prognostic relevance in EV/P-treated patients is unclear. Systemic inflammation may further influence prognosis, yet combined muscle and inflammation assessment has not been evaluated. We examined the impact of baseline sarcopenia, inflammatory markers, and early skeletal muscle change on outcomes with EV/P.

METHODS:

This retrospective single-center study included consecutive la/mUC patients treated with first-line EV/P between October 2023 and July 2025. Sarcopenia was defined using sex-specific L3 skeletal muscle index thresholds. Skeletal muscle was quantified on baseline and early follow-up imaging. The modified Glasgow prognostic score (mGPS) was derived from baseline inflammatory markers and analyzed alone and in combination with sarcopenia. Associations with overall survival (OS), progression-free survival (PFS), radiographic response, and treatment-related toxicity were assessed using Kaplan-Meier and univariable and multivariable regression analyses.

RESULTS:

Thirty-seven patients were included; median age was 76 years, and 62% were sarcopenic at baseline. Baseline sarcopenia was associated with shorter OS in univariable analysis (median 10.7 months vs. not reached; P = .018) but not PFS. However, sarcopenia did not remain independently associated with OS after multivariable adjustment. mGPS alone was not prognostic, though combined sarcopenia and mGPS identified a high-risk subgroup with sarcopenia and mGPS 2. Sarcopenia and early skeletal muscle change were not associated with response or toxicity.

CONCLUSION:

Baseline sarcopenia is common and associated with inferior OS in univariable analyses of EV/P-treated la/mUC, but it was not an independent predictor after multivariable adjustment. Combined sarcopenia and mGPS stratification improves prognostic discrimination and supports integrated muscle and inflammation assessment.

01 Sep 2026·JOURNAL OF UROLOGY

Are Circulating Tumor DNA and Urinary Tumor DNA the New PSA for Clinically Localized Muscle-Invasive Bladder Cancer in the Enfortumab Vedotin/Pembrolizumab Era?

Author: Sharma, Vidit ; Boorjian, Stephen A. ; Li, Eric V.

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News (Medical) associated with Enfortumab Vedotin-ejfv

21 hours ago

·www.biospace.com

Innate Pharma Reports First Half 2026 Business Update and Financial Results

New strategic partnership with Sobi to advance lacutamab is effective, with a $75 million upfront payment; TELLOMAK-3 phase 3 initiated with FPI expected in Q1 2027 €30 million equity financing completed to primarily support IPH4502 and preclinical ADC portfolio IPH4502 Phase 1 dose escalation and cohort enrichment enrollment completed, with initial data to be presented at ENA 2026 PACIFIC-9 Phase 3 readout for monalizumab, led by AstraZeneca, expected in H2 2026 Cash position of €21.4 million 1 as of June 30, 2026 Anticipated cash horizon until the end of Q1 2028, taking into account the initial payment of $75 million expected from the completion of the transaction with Sobi and the proceeds from the €30 million capital increase Conference call to be held today at 2:00 p.m. CEST / 8:00 a.m. ET MARSEILLE, France--(BUSINESS WIRE)-- $IPH #ADC --Regulatory News: Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“Innate” or the “Company”) today reported its consolidated financial results for the six months ended June 30, 2026 . The consolidated financial statements are attached to this press release. “2026 continues to be an important year of execution for Innate, marked by our strategic partnership with Sobi and the strengthening of our financial position,” said Jonathan Dickinson, CEO of Innate Pharma. “With the TELLOMAK-3 Phase 3 study initiated, we are targeting the first patient in the study in Q1 2027 as we work toward a filing for accelerated approval in Sézary syndrome. Looking ahead, we will present Phase 1 data from IPH4502 at ENA 2026 and expect the PACIFIC-9 Phase 3 readout for monalizumab by year-end, as we remain focused on delivering value for patients and shareholders.” _________________ 1 Including short term investments (€4.4 million) and non-current financial instruments (€10.5 million) Webcast and conference call will be held today at 2:00pm CEST (8:00am ET) Access to live webcast: Click here to access the live webcast Participants may also join via telephone using the registration link below: Click here to register This information can also be found on the Investors section of the Innate Pharma website, . A replay of the webcast will be available on the Company website for 90 days following the event. Pipeline highlights: Lacutamab (anti-KIR3DL2 antibody), partnered with Sobi: Cutaneous T-Cell Lymphoma In August 2026, Innate Pharma entered into a strategic partnership with Sobi to license lacutamab in T-cell lymphoma ( Link PR ). The partnership is intended to enable initiation of the TELLOMAK-3 confirmatory Phase 3 study in cutaneous T-cell lymphoma (CTCL), a key step toward filing for accelerated approval of lacutamab in Sézary syndrome, a subtype of CTCL. On September 16, Innate Pharma announced closing of the transaction under the partnership agreement, following expiration of the anti-trust waiting periods and completion of other conditions ( Link PR ). This triggers a USD 75 million upfront payment and marks the initiation of the TELLOMAK-3 confirmatory Phase 3 study, with first patient expected in Q1 2027. Under the agreement, Innate is conducting the TELLOMAK-3 Phase 3 confirmatory trial in cutaneous T-cell lymphoma. The TELLOMAK-3 study will subsequently support applications for full approvals in key jurisdictions in Sézary syndrome and mycosis fungoides, the most common subtype. Sobi will receive exclusive global rights to commercialize lacutamab upon potential accelerated approval and will be eligible to assume full global development rights following positive Phase 3 results. Under the terms of the agreement, Sobi will pay Innate Pharma USD 75 million, payable on closing. Innate will be eligible to receive up to a further USD 40 million in respect of near-term development milestones connected to Sézary syndrome. Additionally, Innate will be eligible to receive up to USD 465 million related to the option for Sobi to get full development rights and to future regulatory and commercial milestones. Innate will be eligible to receive tiered double-digit royalties on net sales. In February 2025, the FDA granted Breakthrough Therapy Designation to lacutamab for relapsed or refractory Sézary syndrome based on TELLOMAK Phase 2 results demonstrating encouraging efficacy and a favorable safety pro patients with Sézary syndrome, heavily pretreated, post-mogamulizumab. Breakthrough Therapy Designation is intended to accelerate the development and regulatory review in the U.S. of drugs that are intended to treat a serious condition and that have shown encouraging early clinical results, which may demonstrate substantial improvement on a clinically significant endpoint over available medicines. Lacutamab has also received Fast Track designation from the FDA, PRIME designation from the EMA and orphan drug status in both the United States and Europe. Peripheral T-Cell Lymphoma (PTCL) The investigator-sponsored Phase 2 KILT (anti-KIR in T-Cell Lymphoma) trial, led by the Lymphoma Study Association (LYSA), evaluating lacutamab in combination with GEMOX (gemcitabine and oxaliplatin) versus GEMOX alone in patients with KIR3DL2-expressing relapsed/refractory PTCL has ended recruitment. IPH4502 (Nectin-4 exatecan ADC): In July 2026, Innate announced completion of dose-escalation and backfill enrollment in the ongoing Phase 1 study of IPH4502, with 76 patients enrolled across multiple tumor types known to express Nectin-4. Preliminary anti-tumor activity has been observed in heavily pre-treated patients, including objective responses in urothelial cancer following prior enfortumab vedotin, as well as in NSCLC and HNSCC. A favorable safety pro been observed to date, with limited hematological toxicity. Initial Phase 1 dose-escalation data will be presented at the 38th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics (ENA 2026) on November 18, 2026. Monalizumab (anti-NKG2A antibody), developed in collaboration with AstraZeneca: PACIFIC-9 is an AstraZeneca-sponsored Phase 3 study evaluating durvalumab in combination with monalizumab or oleclumab in patients with unresectable Stage III NSCLC who have not progressed following platinum-based chemoradiation therapy (CRT). Enrollment in the trial is complete, and data readout is expected in H2 2026. The Phase 3 program is supported by clinical findings from the Phase 2 COAST study, in which the combination of durvalumab and monalizumab suggested prolonged progression-free survival compared with durvalumab alone. IPH5201 (anti-CD39 antibody, developed in collaboration with AstraZeneca): The Phase 2 MATISSE study evaluating IPH5201 in combination with durvalumab and platinum-based chemotherapy in resectable NSCLC is ongoing. Encouraging results from a pre-planned interim analysis presented at AACR 2026 showed an overall pathological complete response rate of 27.5%, with higher response rates observed in patients with PD-L1-positive tumors. Following the interim analysis, MATISSE continues enrollment in the PD-L1 ≥1% patient population. Preclinical ADC pipeline For its preclinical ADC portfolio, Innate is leveraging its proprietary linker technology, in clinical development through IPH4502. Innate’s next-generation ADC approaches include bispecific ADCs designed to address tumor antigen heterogeneity, approaches aimed at enhancing internalization to unlock activity in tumors with low target expression, and dual-payload approaches intended to overcome payload resistance. Post period events and Corporate Update: In August 2026, Innate Pharma announced the appointment of Markus Jensen, 57, as Chief Medical Officer and member of the Executive Leadership Team, effective September 1, 2026. He succeeds Sonia Quaratino and oversees the Company’s clinical development activities as Innate prepares to advance lacutamab into Phase 3 and continues development of IPH4502. Markus Jensen joined Innate Pharma in 2024 as head of clinical pharmacology and has served as global clinical lead for Company key programs, including IPH4502. He brings more than 25 years of experience spanning clinical medicine, academic research and the pharmaceutical industry. Prior to joining Innate, he held leadership positions at Bayer for more than 16 years, with a particular focus on oncology and clinical development. He holds a medical degree from the University of Cologne and is double board certified by Ärztekammer Nordrhein in Internal Medicine and Clinical Pharmacology. On August 18, 2026, Innate completed a capital increase without preferential subscription consisting of a private placement of 17,647,059 new ordinary shares of the Company for aggregate gross proceeds to the Company of an approximately €30 million. Together with the $75 million upfront payment, the proceeds of the private placement are expected to extend the Company’s projected cash runway through end of Q1 2028. As of June 30, 2026, the balance available under our April 2023 sales agreement under the At-The-Market program remains at $75 million. Financials highlights for the first half of 2026: The key elements of Innate’s financial position and financial results as of and for the six-month period ended June 30, 2026 are as follows: Cash, cash equivalents, short-term investments and financial assets amounting to €21.4 million (€m) as of June 30, 2026 (€44.8m as of December 31, 2025). As of June 30, 2026, financial liabilities amount to €20.2m (€22.6m as of December 31, 2025). This change is mainly due to loan repayments. Revenue and other income amounted to €5.7m in the first half of 2026 (€4.9m in the first half of 2025) and mainly comprised of: Revenue from collaboration and licensing agreements, which mainly resulted from the partial or entire recognition of the proceeds received pursuant to the agreements with AstraZeneca and Sanofi. They are recognized when the entity's performance obligation is met. They are recognized at a point in time or spread over time according to the percentage of completion of the work that the Company is committed to carry out under these agreements: (i) Since December 31, 2025, the revenue from collaboration and licensing agreements for monalizumab has been fully recognized. Therefore, no revenue is recognized for the six months ended June 30, 2026, as compared to €0.1 million for the six months ended June 30, 2025. (ii) No revenue related to IPH5201 were generated during the six months ended June 30, 2026 as during the six months ended June 30, 2025. As a reminder, the revenue is related to the milestone payment received from AstraZeneca following the signature on June 1, 2022 of an amendment to the initial contract signed in October 2018. This amendment sets the terms of the collaboration following AstraZeneca’s decision to advance IPH5201 to a Phase 2 study. The Company will conduct the study. Both parties will share the external cost related to the study and incurred by the Company and AstraZeneca will provide products necessary to conduct the clinical trial. Revenue from invoicing of research and development costs for the six months ended June 30, 2026 was 0.4 million compared to 0.9 million for the six months ended June 30, 2025, or a decrease of (0.5) million. (iii) No revenue were generated for the license and collaboration agreement signed with Sanofi in 2016 for the six months ended June 30, 2026, as well as for the six months ended June 30, 2025. On April 23, 2025, the Company announced that, in alignment with both company's current strategic priorities, Sanofi and Innate agreed to terminate the 2016 Agreement as it relates to SAR’579/IPH6101 (CD123 ANKET®). Innate regained the rights to SAR’579/IPH6101 in July 2025. Data from the Sanofi-led Phase 1/2 study and Phase 2 preliminary dose expansion of the trial have been transferred to Innate. In a recent corporate update, Sanofi announced deprioritization of SAR’514, a trifunctional anti-BCMA NK-cell engager. Sanofi retains exclusive development and commercialization rights, and the license terms remain unchanged. It has not triggered any milestone payments as of June 30, 2026. (iiii) Revenue related to the research collaboration and licensing agreement signed with Sanofi in 2022 remained constant over the period, with revenue amounting to €0.2 million for the first half of 2026, as for the first half of 2025. As previously disclosed, in December 2022, the Company entered into a research collaboration and license agreement with Genzyme Corporation, a wholly owned subsidiary of Sanofi (“Sanofi”), under which the Company granted Sanofi an exclusive license to Innate’s B7-H3 ANKET® program and options for two additional targets. In March 2023, Innate Pharma received an upfront payment of €25 million under its research, collaboration and license agreement with Sanofi. This amount consisted of €18.5 million relating to the exclusive license to the B7-H3 technology, which was recognized in profit or loss in June 2023; €1.5 million relating to research activities to be performed over a three-year period, recognized as revenue on a straight-line basis through November 2026; and €5 million relating to the two additional license options, recognized as contract liabilities until their expiration or until the options are exercised. In December 2023, Sanofi exercised one of its license options for an ANKET® program, resulting in the recognition of €2.5 million in revenue and the payment of a €15 million milestone, of which €13.3 million related to the license was recognized immediately in revenue and €1.7 million related to research activities. These research activities were discontinued following the termination of the agreement in October 2024, which led to the full recognition of the €1.7 million in revenue in 2024. As a result, Innate regained the rights to the IPH67 program, while Sanofi retains a right to compensation on any potential future revenues. On January 24, 2026, following the expiration of the deadline to exercise the license option on an identified target, the revenue of €2.5 million has been fully recognized. Sanofi still has a right on a non-exclusive license option for an additional target, exercisable up to January 24, 2028. This option is not linked with any other revenue. Government funding for research expenditures of €2.5m in the first half of 2026 (€3.2m in the first half of 2025), decreasing by €0.6 million, or 20.1% in connection with decrease in personnel expenses following the restructuring of the organization to concentrate preclinical and clinical research and development efforts on higher value assets. Operating expenses are €24.7m in the first half of 2026 (€30.3m in the first half of 2025), of which 68.4% (€16.9m) are related to R&D. R&D expenses decreased by €3.6m to €16.9m in the first half of 2026 (€20.5m in the first half of 2025). This change is explained by direct R&D expenses, which slightly decreased by €1.5 million or 15% to reach €8.2 million for the first half of 2026. This decrease is related to the phasing of studies (maturity of clinical studies on lacutamab, and IPH5201, discontinuation of preclinical studies, partially offset by the ramp-up of IPH4502, our antibody-drug conjugate (ADC). In addition, Personnel and other R&D expenses decreased by €2.2 million, or 20.0%, to €8.6 million for the six months ended June 30, 2026, compared to €10.8 million for the six months ended June 30, 2025. This decrease is primarily due to a reduction in personnel expenses of €2.7 million, resulting from a reduction in the R&D workforce (from 133 to 92 employees), partially offset by a €0.7 million increase in other expenses, corresponding to a provision for risks and charges. General and administrative (G&A) expenses decreased by €2.0m to €7.8m in the first half of 2026 (€9.8m in the first half of 2025) mainly resulting from an decrease in personnel expenses for €1.5 million due to employees reduction (29 employees for the six months ended June 30, 2026 vs. 42 for the six months ended June 30, 2025), a decrease in non-scientific and consulting fees for €0.2 million due to the suspension of the “At the Market” program on the Nasdaq , a decrease in Other expense for €0.2 million in connection with the Director & Officer (D&O) insurance policy. A net financial loss of €0.6m in the first half of 2026 (profit for €4.1m in the first half of 2025). This change is mainly due to an unfavorable variation in net foreign exchange gain with its unfavorable impact on the collaboration liabilities recorded during the first half of 2026 in connection with the change in the dollar exchange rate and an unfavorable variation in income resulting from financial assets and fair value revaluation due to an unfavorable effect of investment rates recorded on the financial markets. A net loss of €19.6m for the first half of 2026 (net loss of €21.3m for the first half of 2025). The table below summarizes the IFRS consolidated financial statements as of and for the six months ended June 30, 2026, including 2025 comparative information. In thousands of euros, except for data per share June 30, 2026 June 30, 2025 Revenue and other income 5,663 4,860 Research and development expenses (16,877) (20,520) General and administrative expenses (7,797) (9,767) Operating expenses (24,674) (30,287) Operating income (loss) (19,011) (25,427) Net financial income (loss) (612) 4,083 Income tax expense — — Net income (loss) (19,623) (21,344) Weighted average number of shares ( in thousands) : 93,827 86,937 - Basic income (loss) per share (0.21) (0.25) - Diluted income (loss) per share (0.21) (0.25) June 30, 2026 December 31, 2025 Cash, cash equivalents and financial assets 21,376 44,765 Total assets 34,726 62,719 Total shareholders’ equity -40,508 -21,704 Total financial debt 20,206 22,571 About Innate Pharma Innate Pharma S.A. is a global, clinical-stage biotechnology company developing immunotherapies for cancer patients. Leveraging its expertise in antibody engineering and innovative target identification, Innate Pharma is developing innovative and differentiated next-generation antibody therapeutics. Innate Pharma is advancing a portfolio of differentiated potential first- and/or best-in-class assets, focused on areas of high unmet medical need. Its proprietary pipeline is centered on antibody-drug conjugates (ADCs), led by IPH4502, a differentiated Nectin-4 ADC in clinical development for solid tumors, and supported by a preclinical portfolio of next-generation ADC candidates. In parallel, Innate is advancing two partnered late-stage assets: lacutamab, developed with Sobi for T-cell lymphomas, and monalizumab, developed with AstraZeneca for non-small cell lung cancer. Innate Pharma has established collaborations with leading biopharmaceutical companies, including Sobi, Sanofi and AstraZeneca, as well as renowned academic and research institutions, to advance innovation in immuno-oncology. Headquartered in Marseille, France, Innate Pharma is listed on Euronext Paris and Nasdaq in the US. Learn more about Innate Pharma at and follow us on LinkedIn and X . Information about Innate Pharma shares ISIN code: FR0010331421 Ticker code: Euronext Paris: IPH | Nasdaq: IPHA LEI: 9695002Y8420ZB8HJE29 Disclaimer on forward-looking information and risk factors This press release contains certain forward-looking statements, including those within the meaning of applicable securities laws, including Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. All statements other than present and historical facts and conditions contained in this press release, including statements regarding the future results of operations and financial position, business strategy, plans and the Company’s objectives for future operations, are forward-looking statements. These are based on the management’s current beliefs, expectations and assumptions about future events, conditions and results and on information currently available to the management. When used in this press release, certain words, including “anticipate,” “plan,” “believe,” “can,” “could,” “estimate,” “project,” “expect,” “may,” “might,” “potential,” “should,” “will,” or the negative of these and similar expressions, identify forward-looking statements. Although the Company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated. These risks and uncertainties include, among other things, the uncertainties inherent in research and development, including related to safety, progression of and results from its ongoing and planned clinical trials and preclinical studies, review and approvals by regulatory authorities of its product candidates, enrolment, results and other milestones of its preclinical trials, the Company’s reliance on third parties to manufacture its product candidates, the Company’s commercialization efforts and the Company’s continued ability to raise capital to fund its development and product trials. For additional discussion of risks and uncertainties, which could cause the Company's actual results, financial condition, performance or achievements to differ materially from those contained in the forward-looking statements, please refer to the Risk Factors (“Facteurs de Risque") section of the Universal Registration Document filed with the French Financial Markets Authority (“AMF”), which is available on the AMF website or on Innate Pharma’s website, and public filings and reports filed with the U.S. Securities and Exchange Commission (“SEC”), including the Company’s Annual Report on Form 20-F for the year ended December 31, 2025, and subsequent filings and reports filed with the AMF or SEC, or otherwise made public by the Company. References to the Company’s website and the AMF website are included for information only and the content contained therein, or that can be accessed through them, are not incorporated by reference into, and do not constitute a part of, this press release. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by the Company or any other person that the Company will achieve its objectives and plans in any specified time frame or at all. The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. This press release and the information contained herein do not constitute an offer to sell or a solicitation of an offer to buy or subscribe to shares in Innate Pharma in any country. Summary of Interim Condensed Consolidated Financial Statements and Notes as of JUNE 30, 2026 Interim Condensed Consolidated Statements of Financial Position (in thousand euros) June 30, 2026 December 31, 2025 Assets Current assets Cash and cash equivalents 6,461 28,092 Short-term investments 4,435 6,218 Trade receivables and others 8,704 12,400 Total current assets 19,600 46,710 Non-current assets Property and equipment 3,643 4,356 Non-current financial assets 10,480 10,455 Other non-current assets 877 947 Trade receivables and others - non-current 126 251 Deferred tax asset Total non-current assets 15,126 16,009 Total assets 34,726 62,719 Liabilities Current liabilities Trade payables and others 11,269 15,042 Collaboration liabilities – current portion 8,995 6,501 Financial liabilities – current portion 10,790 8,802 Deferred revenue – current portion 127 2,825 Provisions - current portion 1,675 3,479 Total current liabilities 32,856 36,649 Non-current liabilities Collaboration liabilities – non-current portion 30,616 31,748 Financial liabilities – non-current portion 9,416 13,771 Defined benefit obligations 1,951 1,923 Deferred revenue – non-current portion — — Provisions - non-current portion 395 332 Total non-current liabilities 42,378 47,775 Shareholders’ equity Share capital 4,697 4,687 Share premium 409,094 408,033 Retained earnings (435,541) (386,365) Other reserves 865 1,118 Net income (loss) (19,623) (49,177) Total shareholders’ equity (40,508) (21,704) Total liabilities and shareholders’ equity 34,726 62,719 Contacts Stéphanie Cornen VP, Investor Relations & Corporate Communications stephanie.cornen@innate-pharma.fr Investor Relations investors@innate-pharma.fr Media communication@innate-pharma.fr Read full story here

Phase 2Phase 1Breakthrough TherapyPhase 3Clinical Result

16 Sep 2026

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Ivonescimab Monotherapy Demonstrates a Statistically Significant & Clinically Meaningful Benefit Compared to Pembrolizumab Monotherapy in PD-L1-Positive Advanced NSCLC in Akeso’s HARMONi-2 Study Conducted in China

Ivonescimab Reduced the Risk of Death by 27% Compared to Pembrolizumab HARMONi-2 Demonstrated an Improvement in Median Overall Survival of 8.2 Months PD-L1 High Expression Subgroup: Hazard Ratio = 0.58 Summit is Conducting Global Phase III HARMONi-7 Study in Patients with PD-L1 High-Expressing NSCLC Summit Therapeutics Inc. (NASDAQ: SMMT) today noted that its partner Akeso Inc. announced that updated data, including overall survival (OS), from the randomized, double-blind Phase III HARMONi-2 trial featuring the novel, potential first-in-class investigational bispecific antibody ivonescimab is being presented at the International Association for the Study of Lung Cancer’s (IASLC) 2026 World Conference on Lung Cancer (WCLC 2026) in Seoul, Republic of Korea. The HARMONi-2 presentation entitled, Overall Survival Analysis From HARMONi-2: Ivonescimab vs Pembrolizumab as First-Line Treatment for PD-L1-Positive NSCLC, evaluated ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have positive PD-L1 expression (PD-L1 Score >1%). HARMONi-2 (AK112-303) is a single-region, multi-center Phase III study conducted in China and sponsored by Akeso, with all relevant data exclusively generated, managed, and analyzed by Akeso. The trial results will be presented by Professor Caicun Zhou, MD, PhD, Chief Physician and Director of the Department of Medical Oncology at Shanghai Pulmonary Hospital, Tongji University School of Medicine, and President of IASLC, on Tuesday September 15, 2026. Clinically Meaningful Efficacy In this protocol-specified interim analysis of OS, a secondary endpoint in the HARMONi-2 study, ivonescimab monotherapy demonstrated a statistically significant and clinically meaningful improvement compared to pembrolizumab monotherapy, achieving a hazard ratio (HR) of 0.73 (95% CI: 0.57, 0.95; p=0.009). A clinically meaningful benefit was demonstrated across important clinical subgroups, including those with PD-L1 low expression (PD-L1 Score 1-49%) and PD-L1 high expression (PD-L1 Score ≥ 50%), along with those with squamous and non-squamous histologies. In this analysis, ivonescimab continued to demonstrate an acceptable and manageable safety pro the HARMONi-2 study, which was consistent with previous Phase III studies of ivonescimab. No additional safety signals were noted in the HARMONi-2 study in this current data cut with longer treatment duration (median of 14 cycles of ivonescimab vs. 10 cycles of pembrolizumab) compared to the previous data cut. Global Phase III HARMONi-7 StudyBased on the primary analysis results of HARMONi-2, Summit initiated the global HARMONi-7 study (NCT06767514) in early 2025. HARMONi-7 is a randomized, double-blind, multi-regional Phase III clinical trial evaluating ivonescimab monotherapy to pembrolizumab monotherapy in the first-line treatment of patients with metastatic NSCLC whose tumors have high PD-L1 expression (PD-L1 Score > 50%). The study is currently recruiting, with a target enrollment of 780 patients globally. The co-primary endpoints of HARMONi-7 are PFS and OS. The HARMONi-2 study is being conducted by Akeso in China, where ivonescimab is approved and commercially available for indications in NSCLC. Ivonescimab remains investigational and is not approved by any regulatory authority in Summit’s license territories, including the United States and Europe. Ivonescimab, known as SMT112 in Summit’s license territories, North America, South America, Europe, the Middle East, Africa, and Japan, and as AK112 outside of Summit’s license territories, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. By design, ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity to PD-1 when in the presence of VEGF. This design is intended to differentiate ivonescimab as there is potentially higher expression (presence) of both PD-1 and VEGF in tumor tissue and the tumor microenvironment (TME) as compared to normal tissue in the body. Summit believes ivonescimab’s specifically engineered tetravalent structure (four binding sites) enables higher avidity (accumulated strength of multiple binding interactions) in the TME (Zhong, et al, iScience, 2025). This tetravalent structure, the intentional novel design of the molecule, and bringing these two targets into a single bispecific antibody with cooperative binding qualities have the potential to direct ivonescimab to the tumor tissue versus healthy tissue. The intent of ivonescimab’s design, together with a half-life of 6 to 7 days after the first dose (Zhong, et al, iScience, 2025) and increasing to approximately 10 days at steady state dosing, is to improve upon previously established efficacy thresholds, side effects, and safety profiles associated with prior approved drugs to these targets. Ivonescimab was engineered by Akeso Inc. (HKEX Code: 9926.HK) and is currently utilized in multiple Phase III clinical trials. Over 4,000 patients have been treated with ivonescimab in clinical studies globally and over 70,000 patients when considering those treated in a commercial setting in China, as noted by Akeso. There are currently 16 Phase III clinical studies that are either announced, ongoing, or have been completed studying ivonescimab, five of which are Summit-sponsored global studies, one of which is a multiregional study sponsored by a cooperative group, and 10 of which are being or have been conducted in China by Akeso. Summit began its clinical development of ivonescimab in NSCLC, commencing enrollment in 2023 in two multiregional Phase III clinical trials, HARMONi and HARMONi-3. In 2025, Summit began enrolling patients in HARMONi-7. Summit expanded its Phase III clinical development program into colorectal cancer (CRC) in the fourth quarter of 2025 by initiating enrollment in HARMONi-GI3. In 2026, Summit announced initiation of HARMONi-GU1, a Phase II/III study in urothelial carcinoma (bladder cancer) with global clinical trial site activations planned to begin by the fourth quarter of 2026. HARMONi is a Phase III clinical trial evaluating ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a third-generation EGFR TKI (e.g., osimertinib). Detailed results of the study were provided in September 2025, and a Biologics License Application (BLA) was submitted to the United States Food and Drug Administration (FDA) for marketing authorization, which the FDA accepted for filing in January 2026; the goal Prescription Drug User Fee Act (PDUFA) date is November 14, 2026. HARMONi-3 is a Phase III clinical trial evaluating ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic, squamous or non-squamous NSCLC, irrespective of PD-L1 expression. The clinical trial is evaluating the two histologies as individual, separately powered cohorts with independent statistical powering. HARMONi-7 is a Phase III clinical trial evaluating ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression. HARMONi-GI3 is a Phase III clinical trial evaluating ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy in patients with first-line unresectable metastatic CRC. HARMONi-GU1 is a Phase II/III clinical trial evaluating ivonescimab plus the antibody drug conjugate (ADC) enfortumab vedotin (EV) compared to pembrolizumab plus EV as first-line therapy in patients with previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC). ILLUMINE is a Phase III study being conducted by GORTEC, a cooperative group dedicated to Head and Neck Oncology, in recurrent / metastatic head and neck squamous cell carcinoma (r/m HNSCC). ILLUMINE is a three-arm Phase III clinical trial designed to evaluate ivonescimab monotherapy, as well as ivonescimab in combination with ligufalimab, Akeso’s proprietary anti-CD47 monoclonal antibody, compared to monotherapy pembrolizumab in patients with PD-L1 positive r/m HNSCC. Five Phase III ivonescimab clinical trials have read out to date, all five with positive data. Four of these five studies are in NSCLC, and one is in biliary tract cancer (BTC). In addition to Summit’s positive HARMONi study, Akeso has had positive read-outs in three single-region (China), randomized Phase III clinical trials in NSCLC, HARMONi-A, HARMONi-2, and HARMONi-6, including a statistically significant overall survival benefit in all three studies. Akeso has also reported a statistically significant OS benefit in the single-region (China), randomized Phase III HARMONi-GI1 trial in advanced BTC. HARMONi-A was a Phase III clinical trial which evaluated ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with an EGFR TKI. HARMONi-2 is a Phase III clinical trial evaluating monotherapy ivonescimab against monotherapy pembrolizumab in patients with locally advanced or metastatic NSCLC whose tumors have positive PD-L1 expression. HARMONi-6 is a Phase III clinical trial evaluating ivonescimab in combination with platinum-based chemotherapy compared with tislelizumab, an anti-PD-1 antibody, in combination with platinum-based chemotherapy in patients with locally advanced or metastatic squamous NSCLC, irrespective of PD-L1 expression. HARMONi-GI1 is a Phase III clinical trial evaluating ivonescimab in combination with chemotherapy compared with durvalumab plus chemotherapy as a first-line treatment for patients with advanced BTC. Akeso is actively conducting additional Phase III clinical studies in settings outside of NSCLC and biliary-tract cancer, including triple-negative breast cancer, head and neck squamous cell carcinoma, small cell lung cancer, colorectal cancer, and pancreatic cancer. Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summit’s license territories, including the United States and Europe. Ivonescimab was initially approved for marketing authorization in China in May 2024. Summit Therapeutics Inc. is a biopharmaceutical oncology company focused on the discovery, development, and commercialization of patient-, physician-, caregiver- and societal-friendly medicinal therapies intended to improve quality of life, increase potential duration of life, and resolve serious unmet medical needs. Summit was founded in 2003 and the company’s shares are listed on the Nasdaq Global Market (symbol "SMMT"). Summit is headquartered in Miami, Florida, with additional offices in Palo Alto, California, Princeton, New Jersey, Dublin, Ireland, and Oxford, UK. References: Xiong A, Wang L, Chen J, Wu L, Liu B, Yao J, et al. Ivonescimab versus pembrolizumab for PD-L1-positive non-small cell lung cancer (HARMONi-2): a randomised, double-blind, phase 3 study in China. Lancet. 2025;405(10481):839-849. doi:10.1016/S0140-6736(24)02722-3. 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Clinical ResultDrug ApprovalImmunotherapy

15 Sep 2026

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Updated HARMONi Data Presented at WCLC 2026 Demonstrate Consistent Overall Survival Results with Ivonescimab Plus Chemotherapy in Western and Asian Patients

Sustained OS Improvement Seen with Longer Follow-Up in Western Patients, Consistent across Geographic Regions; No New Safety Signals Observed Akeso-Sponsored HARMONi-2 OS Data Also Presented at WCLC 2026; Additional Data from Landmark China-Only Study Included Herein MIAMI--(BUSINESS WIRE)--Summit Therapeutics Inc. (Nasdaq: SMMT) announced that updated overall survival (OS) results from the global Phase III HARMONi clinical trial featuring the novel, potential first-in-class investigational bispecific antibody ivonescimab were presented today at the International Association for the Study of Lung Cancer (IASLC) 2026 World Conference on Lung Cancer (WCLC 2026) in Seoul, Republic of Korea. As Summit previously announced on July 22, 2026, ivonescimab plus platinum-doublet chemotherapy in the HARMONi trial continued to show a positive OS trend and a consistent efficacy and safety pro Asian and western patients when compared to placebo plus chemotherapy. “Updated results from the global Phase III HARMONi study show that ivonescimab combined with chemotherapy continued to demonstrate a consistent overall survival improvement compared with placebo plus chemotherapy in patients with EGFR-mutated non-small cell lung cancer following prior treatment with a third-generation EGFR TKI,” said Antonio Passaro, M.D., Ph.D., Director of the Division of Thoracic Oncology, European Institute of Oncology (IEO) in Milan, Italy, and presenting author. “Importantly, with longer follow-up, the survival improvement observed in western patients was consistent with the global population, reinforcing the relevance of these results across geographic regions in a setting where patients continue to need additional treatment options after progression on EGFR-targeted therapy.” HARMONi Detailed Efficacy and Safety Results The HARMONi study is evaluating ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with epidermal growth factor receptor (EGFR)-mutated, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who were previously treated with a third-generation EGFR tyrosine kinase inhibitor (TKI). The study demonstrated a statistically significant benefit in the primary analysis for progression-free survival (PFS), one of the study’s two primary endpoints, the other being OS. In April 2025, the primary OS analysis was performed, whereby ivonescimab in combination with chemotherapy showed a positive trend without achieving a statistically significant benefit with a hazard ratio of 0.79 (95% CI: 0.62 – 1.01; p=0.057). Median OS was 16.8 months for those patients administered ivonescimab plus chemotherapy vs. 14.0 months for those receiving placebo plus chemotherapy. At the time of the primary analysis, median follow-up time for western patients was 9.2 months which was less than the median OS. An additional analysis was performed with a data cut-off date in June 2026, whereby most western patients have discontinued or completed two years of treatment (median follow-up time 23.2 months for western patients). Median follow-up time for Asian patients was 32.7 months (this was reached in April 2025 and Asian patient data was locked at the time of that analysis). The updated June 2026 analysis continued to show consistent, favorable OS results, with an OS hazard ratio of 0.76 (95% CI: 0.61 – 0.95; nominal p=0.0151) in the global intention-to-treat (ITT) population. An OS hazard ratio of 0.76 was demonstrated in the western patient subgroup (95% CI: 0.52 – 1.10), which was consistent with the ITT population and Asian subgroup. Global ITT Overall Survival Analyses at Each Data Cut-Off DCO: Apr 2025 (Primary Analysis) DCO: Sept 2025* DCO: June 2026* Ivonescimab + Chemo Placebo + Chemo Ivonescimab + Chemo Placebo + Chemo Ivonescimab + Chemo Placebo + Chemo (n=219) (n=219) (n=219) (n=219) (n=219) (n=219) Median OS, ITT 16.8 mos 14.0 mos 16.8 mos 14.0 mos 16.8 mos 14.0 mos Hazard Ratio, ITT 0.79 (95% CI: 0.62 – 1.01; p=0.057) 0.78 (95% CI: 0.62 – 0.98; nominal p=0.0332) 0.76 (95% CI: 0.61 – 0.95; nominal p=0.0151) DCO = data cut-off; ITT = i ntention- t o- t reat population; mos = months; chemo = chemotherapy *DCO for Asian patients was Apr 2025 for both Sept 2025 and June 2026 analyses With longer follow-up, western patients replicated the survival improvement seen in Asian patients, further reinforcing the regional consistency of the efficacy results observed in the global HARMONi study. Western Subgroup of Overall Survival Analyses at Each Data Cut- Off DCO: Apr 2025 DCO: Sept 2025 DCO : June 2026 Ivonescimab + Chemo Placebo + Chemo Ivonescimab + Chemo Placebo + Chemo Ivonescimab + Chemo Placebo + Chemo (n=83) (n=82) (n=83) (n=82) (n=83) (n=82) Median OS, Western Patients Not Reached 14.0 mos 17.0 mos 14.0 mos 17.5 mos 14.0 mos Hazard Ratio, Western Patients 0.98 (95% CI: 0.55 – 1.73) 0.84 (95% CI: 0.53 – 1.32) 0.76 (95% CI: 0.52 – 1.10) Median follow-up, Western Patients 9.2 mos 13.7 mos 23.2 mos DCO = data cut-off; ITT = i ntention- t o- t reat population; mos = months; chemo = chemotherapy In this most recent analysis, ivonescimab continued to demonstrate an acceptable and manageable safety pro was consistent with previous Phase III data of ivonescimab plus chemotherapy. No additional safety signals were noted in this latest HARMONi data cut. “The updated HARMONi overall survival analysis presented at WCLC 2026 provides important additional evidence of the consistency of ivonescimab’s clinical pro patient populations, with western patients showing consistent survival improvement to what was observed in Asian patients,” stated Dr. Maky Zanganeh, President and Co-Chief Executive Officer of Summit. “Together with the continued acceptable and manageable safety profile, these data reinforce our confidence in the HARMONi results as we work toward the potential approval of ivonescimab in the U.S.” “What continues to distinguish ivonescimab is not only the strength of these HARMONi results, but the expanding clinical data sets emerging across studies and tumor types, including recent positive results from HARMONi-2 and HARMONi-GI1 in biliary tract cancer,” added Robert W. Duggan, Chairman and Co-Chief Executive Officer of Summit. “Together, these data reinforce our belief in the potential breadth of ivonescimab’s differentiated bispecific design as an important new therapeutic approach in oncology, beginning with EGFR-mutated non-small cell lung cancer and extending across our broader ambition to address serious needs in solid tumors where patients urgently need better options.” Summit’s Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) is based on the results from the HARMONi trial and has a Prescription Drug User Fee Act (PDUFA) goal action date of November 14, 2026. HARMONi-2 Detailed OS Efficacy and Safety Results Previously, key findings from the HARMONi-2 primary OS analysis were announced by Summit’s partner, Akeso Inc. Today, the full detailed results were presented at WCLC 2026, with highlights provided below. HARMONi-2 (AK112-303) is a single-region, multi-center Phase III study conducted in China and sponsored by Akeso, with all relevant data exclusively generated, managed, and analyzed by Akeso. In this protocol-specified interim analysis of OS, a secondary endpoint in the HARMONi-2 study, ivonescimab monotherapy demonstrated a statistically significant and clinically meaningful improvement compared to pembrolizumab monotherapy, achieving a hazard ratio (HR) of 0.73 (95% CI: 0.57, 0.95; p=0.009). A clinically meaningful benefit was demonstrated across important clinical subgroups, including those with PD-L1 low expression (PD-L1 Score 1-49%) and PD-L1 high expression (PD-L1 Score ≥ 50%), along with those with squamous and non-squamous histologies. HARMONi-2 ITT (n=398) Median Follow-up: 36.0 mos Ivonescimab (n=198) Pembrolizumab (n=200) Median OS 30.8 mos (95% CI: 25.4, 37.8) 22.6 mos (95% CI: 17.8, 26.5) OS Stratified HR 0.73 (95% CI: 0.57, 0.95; p=0.009) 24-Month KM OS Rate 57.9% 48.0% 36-Month KM OS Rate 45.0% 33.1% ITT = i ntention- t o- t reat population; mos = months; CI = confidence interval, KM= Kaplan Meier method HARMONi-2 Subgroup Analyses Descriptive, not formally powered Ivonescimab vs. Pembrolizumab PD-L1 High (PD-L1 Score ≥50%) HR = 0.58 (95% CI: 0.38, 0.89) n=168 Median OS: NR vs. 23.2 mos PD-L1 Low (PD-L1 Score 1-49%) HR = 0.85 (95% CI: 0.61, 1.18) n=230 Median OS: 28.5 mos vs. 22.1 mos Squamous Histology HR = 0.65 (95% CI: 0.45, 0.95) n=181 Median OS: 30.5 mos vs. 19.3 mos Non-Squamous Histology HR = 0.79 (95% CI: 0.55, 1.14) n=217 Median OS: 33.6 mos vs. 25.6 mos Age <65 HR = 0.75 (95% CI: 0.51, 1.11) n=182 Median OS: 32.8 mos vs. 25.0 mos Age ≥65 HR = 0.72 (95% CI: 0.51, 1.01) n=216 Median OS: 30.2 mos vs. 22.1 mos Male HR = 0.74 (95% CI: 0.56, 0.98) n=333 Female HR = 0.69 (95% CI: 0.38, 1.25) n=65 NR = not reached; mos = months; CI=confidence interval; n = number In this analysis, ivonescimab continued to demonstrate an acceptable and manageable safety pro the HARMONi-2 study, which was consistent with previous Phase III studies of ivonescimab. No additional safety signals were noted in the HARMONi-2 study in this current data cut with longer treatment duration (median of 14 cycles of ivonescimab vs 10 cycles of pembrolizumab) compared to the previous data cut. Treatment-Related Adverse Events Median follow-up: 36.0 mos Ivonescimab (n=198) Pembrolizumab (n=200) Serious TRAEs, n (%) 59 (29.9) 43 (21.6) TRAEs Leading to Discontinuation, n (%) 8 (4.1) 10 (5.0) TRAEs Leading to Death, n (%) 1 (0.5) 3 (1.5) TRAEs = treatment-related adverse events; n = number; mos = months About Ivonescimab Ivonescimab, known as SMT112 in Summit’s license territories, North America, South America, Europe, the Middle East, Africa, and Japan, and as AK112 outside of Summit’s license territories, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. By design, ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity to PD-1 when in the presence of VEGF. This design is intended to differentiate ivonescimab as there is potentially higher expression (presence) of both PD-1 and VEGF in tumor tissue and the tumor microenvironment (TME) as compared to normal tissue in the body. Summit believes ivonescimab’s specifically engineered tetravalent structure (four binding sites) enables higher avidity (accumulated strength of multiple binding interactions) in the TME (Zhong, et al , iScience, 2025). This tetravalent structure, the intentional novel design of the molecule, and bringing these two targets into a single bispecific antibody with cooperative binding qualities have the potential to direct ivonescimab to the tumor tissue versus healthy tissue. The intent of ivonescimab’s design, together with a half-life of 6 to 7 days after the first dose (Zhong, et al , iScience, 2025) and increasing to approximately 10 days at steady state dosing, is to improve upon previously established efficacy thresholds, side effects, and safety profiles associated with prior approved drugs to these targets. Ivonescimab was engineered by Akeso Inc. (HKEX Code: 9926.HK) and is currently utilized in multiple Phase III clinical trials. Over 4,000 patients have been treated with ivonescimab in clinical studies globally and over 70,000 patients when considering those treated in a commercial setting in China, as noted by Akeso. There are currently 16 Phase III clinical studies that are either announced, ongoing, or have been completed studying ivonescimab, five of which are Summit-sponsored global studies, one of which is a multiregional study sponsored by a cooperative group, and 10 of which are being or have been conducted in China by Akeso. Summit began its clinical development of ivonescimab in NSCLC, commencing enrollment in 2023 in two multiregional Phase III clinical trials, HARMONi and HARMONi-3. In 2025, Summit began enrolling patients in HARMONi-7. Summit expanded its Phase III clinical development program into colorectal cancer (CRC) in the fourth quarter of 2025 by initiating enrollment in HARMONi-GI3. In 2026, Summit announced initiation of HARMONi-GU1, a Phase II/III study in urothelial carcinoma (bladder cancer) with global clinical trial site activations planned to begin by the fourth quarter of 2026. HARMONi is a Phase III clinical trial evaluating ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a third-generation EGFR TKI (e.g., osimertinib). Detailed results of the study were provided in September 2025, and a Biologics License Application (BLA) was submitted to the United States Food and Drug Administration (FDA) for marketing authorization, which the FDA accepted for filing in January 2026; the goal Prescription Drug User Fee Act (PDUFA) date is November 14, 2026. HARMONi-3 is a Phase III clinical trial evaluating ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic, squamous or non-squamous NSCLC, irrespective of PD-L1 expression. The clinical trial is evaluating the two histologies as individual, separately powered cohorts with independent statistical powering. HARMONi-7 is a Phase III clinical trial evaluating ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression. HARMONi-GI3 is a Phase III clinical trial evaluating ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy in patients with first-line unresectable metastatic CRC. HARMONi-GU1 is a Phase II/III clinical trial evaluating ivonescimab plus the antibody drug conjugate (ADC) enfortumab vedotin (EV) compared to pembrolizumab plus EV as first-line therapy in patients with previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC). ILLUMINE is a Phase III study being conducted by GORTEC, a cooperative group dedicated to Head and Neck Oncology, in recurrent / metastatic head and neck squamous cell carcinoma (r/m HNSCC). ILLUMINE is a three-arm Phase III clinical trial designed to evaluate ivonescimab monotherapy, as well as ivonescimab in combination with ligufalimab, Akeso’s proprietary anti-CD47 monoclonal antibody, compared to monotherapy pembrolizumab in patients with PD-L1 positive r/m HNSCC. Five Phase III ivonescimab clinical trials have read out to date, all five with positive data. Four of these five studies are in NSCLC, and one is in biliary tract cancer (BTC). In addition to Summit’s positive HARMONi study, Akeso has had positive read-outs in three single-region (China), randomized Phase III clinical trials, HARMONi-A, HARMONi-2, and HARMONi-6, for ivonescimab in NSCLC, including a statistically significant overall survival benefit in all three studies from China. Akeso has also reported a statistically significant OS benefit in the single-region (China), randomized Phase III HARMONi-GI1 trial in advanced BTC. HARMONi-A was a Phase III clinical trial which evaluated ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with an EGFR TKI. HARMONi-2 is a Phase III clinical trial evaluating monotherapy ivonescimab against monotherapy pembrolizumab in patients with locally advanced or metastatic NSCLC whose tumors have positive PD-L1 expression. HARMONi-6 is a Phase III clinical trial evaluating ivonescimab in combination with platinum-based chemotherapy compared with tislelizumab, an anti-PD-1 antibody, in combination with platinum-based chemotherapy in patients with locally advanced or metastatic squamous NSCLC, irrespective of PD-L1 expression. HARMONi-GI1 is a Phase III clinical trial evaluating ivonescimab in combination with chemotherapy compared with durvalumab plus chemotherapy as a first-line treatment for patients with advanced BTC. Akeso is actively conducting additional Phase III clinical studies in settings outside of NSCLC and biliary-tract cancer, including triple-negative breast cancer, head and neck squamous cell carcinoma, small cell lung cancer, colorectal cancer, and pancreatic cancer. Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summit’s license territories, including the United States and Europe. Ivonescimab was initially approved for marketing authorization in China in May 2024. About Summit Therapeutics Inc. Summit Therapeutics Inc. is a biopharmaceutical oncology company focused on the discovery, development, and commercialization of patient-, physician-, caregiver- and societal-friendly medicinal therapies intended to improve quality of life, increase potential duration of life, and resolve serious unmet medical needs. Summit was founded in 2003 and the company’s shares are listed on the Nasdaq Global Market (symbol "SMMT"). Summit is headquartered in Miami, Florida, with additional offices in Palo Alto, California, Princeton, New Jersey, Dublin, Ireland, and Oxford, UK. For more information, please visit and follow Summit on X @SMMT_TX. Summit Forward-Looking Statements Any statements in this press release about the Company’s future expectations, plans and prospects, including but not limited to, statements about the clinical and preclinical development of the Company’s product candidates, entry into and actions related to the Company’s partnership with Akeso Inc. and other collaborations, the intended use of the net proceeds from the private placements, the Company's anticipated spending and cash runway, the therapeutic potential of the Company’s product candidates, the potential commercialization of the Company’s product candidates, the timing of initiation, completion and availability of data from clinical trials, the potential submission of applications for marketing approvals, the expected timing of BLA submissions or FDA decisions, potential acquisitions, statements about the previously disclosed At-The-Market equity offering program (“ATM Program”), the expected proceeds and uses thereof, the Company’s estimates regarding stock-based compensation, and other statements containing the words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "would," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the Company’s ability to sell shares of our common stock under the ATM Program, the conditions affecting the capital markets, general economic, industry, or political conditions, including the effects of geopolitical developments, domestic and foreign trade policies, and monetary policies, the results of our evaluation of the underlying data in connection with the development and commercialization activities for ivonescimab, the outcome of discussions with regulatory authorities, including the Food and Drug Administration, the uncertainties inherent in the initiation of future clinical trials, availability and timing of data from ongoing and future clinical trials, the results of such trials, and their success, global public health crises, that may affect timing and status of our clinical trials and operations, whether preliminary results from a clinical trial will be predictive of the final results of that trial or whether results of early clinical trials or preclinical studies will be indicative of the results of later clinical trials, whether business development opportunities to expand the Company’s pipeline of drug candidates, including without limitation, through potential acquisitions of, and/or collaborations with, other entities occur, expectations for regulatory approvals, laws and regulations affecting government contracts and funding awards, availability of funding sufficient for the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements and other factors discussed in the "Risk Factors" and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of filings that the Company makes with the Securities and Exchange Commission. Summit defines a “positive study” as a clinical study with one or more prespecified primary endpoints in which one of those endpoints achieves a statistically significant benefit according to the protocol or statistical analysis plan. Any change to our ongoing trials could cause delays, affect our future expenses, and add uncertainty to our commercialization efforts, as well as to affect the likelihood of the successful completion of clinical development of ivonescimab. Accordingly, readers should not place undue reliance on forward-looking statements or information. In addition, any forward-looking statements included in this press release represent the Company’s views only as of the date of this release and should not be relied upon as representing the Company’s views as of any subsequent date. The Company specifically disclaims any obligation to update any forward-looking statements included in this press release. Summit Therapeutics and the Summit Therapeutics logo are registered trademarks of Summit Therapeutics Inc. and/or its affiliates. Copyright 2026, Summit Therapeutics Inc. All Rights Reserved. Contacts Summit Therapeutics’ Media & Investor Contacts: Nathan LiaBraaten Senior Director, Investor Relations Tracy Jones Director, Media & Public Relations investors@smmttx.com media@smmttx.com

100 Deals associated with Enfortumab Vedotin-ejfv

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KEGG	Wiki	ATC	Drug Bank
D11525	Enfortumab Vedotin-ejfv	L01XC	DB13007

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Muscle Invasive Bladder Carcinoma	United States	Astellas Pharma US, Inc.	21 Nov 2025
Unresectable Urothelial Carcinoma	European Union	Astellas Pharma Europe Ltd.	24 Sep 2024
Unresectable Urothelial Carcinoma	Iceland	Astellas Pharma Europe Ltd.	24 Sep 2024
Unresectable Urothelial Carcinoma	Liechtenstein	Astellas Pharma Europe Ltd.	24 Sep 2024
Unresectable Urothelial Carcinoma	Norway	Astellas Pharma Europe Ltd.	24 Sep 2024
Locally Advanced Urothelial Carcinoma	European Union	Astellas Pharma Europe Ltd.	13 Apr 2022
Locally Advanced Urothelial Carcinoma	Iceland	Astellas Pharma Europe Ltd.	13 Apr 2022
Locally Advanced Urothelial Carcinoma	Liechtenstein	Astellas Pharma Europe Ltd.	13 Apr 2022
Locally Advanced Urothelial Carcinoma	Norway	Astellas Pharma Europe Ltd.	13 Apr 2022
Metastatic urothelial carcinoma	European Union	Astellas Pharma Europe Ltd.	13 Apr 2022
Metastatic urothelial carcinoma	Iceland	Astellas Pharma Europe Ltd.	13 Apr 2022
Metastatic urothelial carcinoma	Liechtenstein	Astellas Pharma Europe Ltd.	13 Apr 2022
Metastatic urothelial carcinoma	Norway	Astellas Pharma Europe Ltd.	13 Apr 2022
Transitional Cell Carcinoma	United States	Astellas Pharma US, Inc.	18 Dec 2019

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Non-Muscle Invasive Bladder Neoplasms	NDA/BLA	European Union	Astellas Pharma Europe Ltd.	21 May 2026
Muscle Invasive Bladder Urothelial Carcinoma	Phase 3	United States	Astellas Pharma Global Development, Inc.	30 Mar 2020
Muscle Invasive Bladder Urothelial Carcinoma	Phase 3	China	Astellas Pharma Global Development, Inc.	30 Mar 2020
Muscle Invasive Bladder Urothelial Carcinoma	Phase 3	Japan	Astellas Pharma Global Development, Inc.	30 Mar 2020
Muscle Invasive Bladder Urothelial Carcinoma	Phase 3	Argentina	Astellas Pharma Global Development, Inc.	30 Mar 2020
Muscle Invasive Bladder Urothelial Carcinoma	Phase 3	Australia	Astellas Pharma Global Development, Inc.	30 Mar 2020
Muscle Invasive Bladder Urothelial Carcinoma	Phase 3	Belgium	Astellas Pharma Global Development, Inc.	30 Mar 2020
Muscle Invasive Bladder Urothelial Carcinoma	Phase 3	Canada	Astellas Pharma Global Development, Inc.	30 Mar 2020
Muscle Invasive Bladder Urothelial Carcinoma	Phase 3	Czechia	Astellas Pharma Global Development, Inc.	30 Mar 2020
Muscle Invasive Bladder Urothelial Carcinoma	Phase 3	Denmark	Astellas Pharma Global Development, Inc.	30 Mar 2020

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04700124 (KEYNOTE-B15, Pubmed \| N Engl J Med)	Phase 3	Bladder Cancer Adjuvant \| Neoadjuvant	808	Enfortumab Vedotin + Pembrolizumab	pxbmeggekp(yrmuukdwsn) = rtxbwcbvwd mfsyonjwam (kqyqrpbnwq ) View more	Positive	23 Jul 2026
				Cisplatin-Gemcitabine	pxbmeggekp(yrmuukdwsn) = lsddmxcedp mfsyonjwam (kqyqrpbnwq ) View more
NCT03924895 (KEYNOTE-866 and KEYNOTE-905/EV-303 \| KEYNOTE-905 \| EV-303 \| MK-3475-905, CTgov)	Phase 3	Muscle Invasive Bladder Carcinoma	595	Surgery (radical cystectomy (RC) plus Pelvic Lymph Node Dissection [PLND])+Pembrolizumab (Arm A: Pembrolizumab + Surgery)	sfdcyveyzy(ykatrwcpbo) = skkivfpnmd jekyophqqk (tcrlyzxnwe, acsxvuwqeb - fhevwfstfb) View more	-	30 Jun 2026
				Surgery (radical cystectomy (RC) plus Pelvic Lymph Node Dissection [PLND]) (Arm B: Surgery Alone)	vjahpywcyu(yhgpwjltgh) = riplmgkaoz tcbrlsbutq (lrqetfdfxy, tylidxqxnp - nvcynqclpa) View more
NCT03288545 (EV-302, ASCO_Breakthrough2026)	Phase 3	Advanced Urothelial Carcinoma First line	468	Enfortumab vedotin plus pembrolizumab (EV+P)	bkwkrdlssy(hhrjlcitxa): HR = 0.47 (95.0% CI, 0.38 - 0.58) View more	Positive	25 Jun 2026
				platinum-based chemotherapy (PBCT)
ASCO2026	Not Applicable	Advanced Urothelial Carcinoma	464	Enfortumab vedotin + pembrolizumab (with baseline liver metastases)	hgbldveyij(eurpedrlyn) = fpsulyxkzz cmitljptjl (kyrrztzvif )	Positive	29 May 2026
				Enfortumab vedotin + pembrolizumab (without baseline liver metastases)	hgbldveyij(eurpedrlyn) = qahyngvfbc cmitljptjl (kyrrztzvif )
ASCO2026	Not Applicable	Advanced Urothelial Carcinoma	101	Enfortumab vedotin±pembrolizumab (EV)	qbrguiphok(xorbldiuui) = overall 5 (n = 16) vs 6 (n = 33); EV 3 (n = 7) vs 5 (n = 21); EVP 5 (n = 9) vs 7 (n = 12) ftbjazuwth (ujfkosjsck )	Positive	29 May 2026
				Enfortumab vedotin±pembrolizumab (EVP)
ASCO2026	Not Applicable	Transitional Cell Carcinoma	78	Enfortumab vedotin + Pembrolizumab	jnqodawstj(zscoaummiu) = fzwvbnwege tfzvliwbzm (mfoxgaoati ) View more	Negative	29 May 2026
				Enfortumab vedotin	jnqodawstj(zscoaummiu) = gnpierukny tfzvliwbzm (mfoxgaoati ) View more
ASCO2026	Not Applicable	Metastatic urothelial carcinoma	159	Enfortumab vedotin + Pembrolizumab (Synchronous met)	ciurgokwgd(oggpboyuot) = fzzxkcrjcs ssowrmpcba (yxrorhjawv ) View more	Positive	29 May 2026
				Enfortumab vedotin + Pembrolizumab (Metachronous met)	ciurgokwgd(oggpboyuot) = xuaxgotzid ssowrmpcba (yxrorhjawv ) View more
ASCO2026	Not Applicable	Transitional Cell Carcinoma First line	264	Enfortumab vedotin plus pembrolizumab (EV+P)	fjotxiayjt(dwoywldzqc) = Corticosteroids were administered in 7 (41%) ffxiydvevy (sbbvavfjtg ) View more	Positive	29 May 2026
ASCO2026	Not Applicable	Metastatic urothelial carcinoma	30	Enfortumab vedotin + pembrolizumab	pfrgadmdap(tjkwkbnujp) = qslenrphuy hdtiujafif (yqziuntcyc, 15.2 - 44.5) View more	Positive	29 May 2026
ASCO2026	Not Applicable	Solid tumor	15,810	Ado-trastuzumab emtansine	weskupwgty(riwbgracku) = aijlxsbrxc dxaajlkicn (aqtrakbrzw ) View more	Positive	29 May 2026
				Enfortumab vedotin	xcugxjkrka(zakyewbnuu) = idphtijfwz lyezqbcsud (oshphykbxj ) View more

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