Open-Label, Single-Arm, Phase 1b Clinical Trial of NAI Plus Pembrolizumab With Short Course of Enfortumab Vedotin in Treatment-Naïve Participants With Metastatic Urothelial Carcinoma

This phase Ib trial will investigate the effect of N-803 in combination with pembrolizumab and enfortumab vedotin in treating participants with urothelial cancer 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).

Start Date01 Dec 2026

Sponsor / Collaborator

ImmunityBio, Inc.

NCT07756593

/ Not yet recruitingPhase 1IIT

A Phase Ib Study Evaluating the Safety and Tolerability of Sipuleucel-T (Sip-T) in Combination With N-803 in Patients With Metastatic Androgen Pathway Modulation Resistant (mAPMR) Prostate Cancer

This phase Ib single-center open-label de-escalation study uses a modified 3+3 design to determine the safety, tolerability, and recommended phase II dose (RP2D) of the combination of standard of care Sip-T and N-803 in patients with metastatic androgen pathway modulation resistant (mAPMR) prostate cancer. Patients will receive treatment for up to 8 weeks.

Start Date30 Nov 2026

Sponsor / Collaborator

Washington University School of Medicine

[+2]

NCT05642195

/ SuspendedPhase 1/2IIT

Phase I/II Evaluation of a Cancer Lysate Vaccine and Montanide(R) ISA-51 VG With or Without the IL-15 Super-Agonist N-803 as Adjuvant Therapy for PD-L1 Negative Non-Small Cell Lung Cancer

Background:
Surgery is the primary treatment for non-small cell lung cancer (NSCLC) that is diagnosed in its earlier stages. But the tumors often return. Radiation and chemotherapy can improve survival in some people who have had surgery for NSCLC, but these treatments also cause serious side effects. A new approach, called immunotherapy, may be a better way to stop NSCLC tumors from coming back.
Objective:
To test a new treatment (H1299 lung cancer cell vaccine combined with the drug N-803) in people who received surgery for NSCLC.
Eligibility:
Adults aged 18 years or older with no sign of disease after surgery for NSCLC.
Design:
Participants will be screened. They will have a physical exam with blood tests. They will have tests of their heart and lung function. They will have imaging scans.
Study treatment will be given in 28-day cycles. Participants will visit the clinic on the first day of each cycle. They will receive 2 treatments at each visit:
The study vaccine is given as 2-4 small shots under the skin of the thigh or arm.
N-803 is given as a shot under the skin of the abdomen.
Treatment will continue for 6 cycles. Blood tests and imaging scans will be repeated throughout the study.
Participants will have a blood test 1 month after receiving the 6th vaccine. Some participants may then resume taking N-803; they may also receive 2 more vaccinations at 3 and 6 months after their previous treatment.
Follow-up visits will continue for up to 5 years.

Start Date02 Nov 2026

Sponsor / Collaborator

National Cancer Institute

100 Clinical Results associated with Nogapendekin alfa inbakicept-pmln

100 Translational Medicine associated with Nogapendekin alfa inbakicept-pmln

100 Patents (Medical) associated with Nogapendekin alfa inbakicept-pmln

419

Literatures (Medical) associated with Nogapendekin alfa inbakicept-pmln

31 Dec 2026·OncoImmunology

IL-15 trans-presentation at the innate-adaptive interface: mechanisms and translation in cancer immunotherapy

Review

Author: Goldman, Corey Keith

Durable antitumor immunity requires innate activation, antigen presentation, lymphocyte priming, trafficking, and effector function. In immunologically cold tumors, deficient dendritic-cell and natural killer (NK)-cell activation limits the transition from tumor-antigen recognition to CD8 T-cell immunity. Interleukin-15 (IL-15) is a member of the common gamma-chain cytokine family with a distinctive receptor-delivery system at this innate-adaptive interface. In native trans-presentation, IL-15 is stabilized by IL-15 receptor alpha (IL-15Rα) on an antigen-presenting cell and presented to CD122/CD132 on an apposed NK or memory CD8 T cell. This contact-dependent arrangement supports NK-cell homeostasis, memory CD8 T-cell maintenance, and spatially restricted signaling while avoiding the CD25-dependent regulatory T-cell preference of IL-2. IL-12, IL-15, and IL-18 can generate cytokine-induced memory-like NK cells with enhanced recall. These programs are constrained by intrinsic CISH feedback and by tumor-associated TGF-β, PD-L1, TIGIT, adenosine, and other suppressive pathways. Pharmacologic IL-15 receptor agonizts such as N-803 reproduce selected receptor-binding features of trans-presentation but do not reproduce its native source-cell, contact, or spatial restrictions. The durable activity of intravesical N-803 plus bacillus Calmette-Guérin in BCG-unresponsive non-muscle-invasive bladder cancer establishes clinical relevance in a localized combination setting, whereas systemic solid-tumor studies have shown pharmacodynamic lymphocyte expansion with more limited or variable clinical activity. This narrative review synthesizes IL-15 receptor biology, innate and adaptive effector programs, counter-regulation, and clinical translation. It presents the 'innate bootstrap' as a mechanistic hypothesis: appropriately timed IL-15-axis engagement may strengthen an impaired innate-to-adaptive handoff, with efficacy determined by route, tissue context, partner therapy, exposure schedule, and patient selection.

31 Dec 2026·JOURNAL OF MEDICAL ECONOMICS

Budget impact model of nadofaragene firadenovec for the treatment of high-risk non-muscle-invasive bladder cancer that is unresponsive to Bacillus Calmette-Guérin immunotherapy

Article

Author: Ye, Dongni ; Yang, Min ; Chai, Xinglei ; Moradi, Ashton ; Zhao, Angela ; Lotan, Yair

AIMS:

To estimate the budget impact of adopting nadofaragene firadenovec for the treatment of adults with high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ with or without papillary tumors (CIS ± Ta/T1) from a US third-party payer's perspective.

METHODS:

A budget impact model was developed to compare total healthcare costs under two scenarios: (1) with nadofaragene firadenovec included in the treatment mix, and (2) without it. The model simulated a hypothetical US health plan covering one million members over a 3-year time horizon. Costs assessed included drug acquisition and administration, surveillance and disease management, cystectomy, and treatment-related adverse events (AEs). Base-case inputs were informed by trial data, published literature, and real-world evidence. Scenario analyses explored alternative population definitions, epidemiology and clinical inputs; one-way sensitivity analyses tested parameter uncertainty.

RESULTS:

In the base-case, the estimated per-member-per-month (PMPM) budget impact of adopting nadofaragene firadenovec ranged from $0.0010 in Year 1 to $0.0084 in Year 3. Increased drug and administration costs were partially offset by cost savings from reduced disease progression, fewer cystectomies, and lower AE rates. Scenario analyses demonstrated that even examining a broader population including papillary disease-only patients, the budget impact remained modest ($0.0064-$0.0548 PMPM from Years 1-3). Sensitivity analyses confirmed that results were most influenced by uptake rate, drug cost, and target population size.

LIMITATIONS:

Key limitations include reliance on projected market shares for nadofaragene firadenovec, omission of recently approved treatments (nogapendekin alfa inbakicept-pmln and TAR-200) due to the lack of publicly available market share data, and assumptions to derive clinical outcomes for certain treatments due to lack of reported data.

CONCLUSIONS:

Despite its higher acquisition cost, the inclusion of nadofaragene firadenovec resulted in a minimal budget impact as bladder-sparing option for patients with BCG-unresponsive NMIBC with CIS ± Ta/T1.

01 Nov 2026·EPIDEMIOLOGY

Vaccine Efficacy Against Naturally Asymptomatic Infections

Article

Author: Lipsitch, Marc ; Benkeser, David ; Rogawski McQuade, Elizabeth T. ; Dean, Natalie ; Nabi, Razieh ; Codi, Allison

The naive approach to estimating the effects of a vaccine on asymptomatic infections, which compares the risk of asymptomatic infection among vaccinated and unvaccinated individuals, can be misleading because it comprises two effects: the vaccine preventing asymptomatic infections and the vaccine converting symptomatic to asymptomatic infections. When the latter effect is strong, vaccines can appear harmful with respect to asymptomatic infections. Using a causal principal stratification framework, we formalize an estimand, vaccine efficacy against naturally asymptomatic infection (VE NAI ), that describes the efficacy of a vaccine in preventing asymptomatic infections among individuals who would naturally (i.e., in the absence of vaccine) be expected to be asymptomatic. This estimand excludes vaccine effects that convert symptomatic cases to asymptomatic infections, and we demonstrate how this makes it a more natural analogue of the usual vaccine efficacy estimands against infection and symptomatic disease. We describe the assumptions under which this estimand can be identified and estimated from randomized and observational studies. We further identify and estimate bounds that do not require cross-world independence assumptions and characterize sensitivity analyses around the main assumption needed for identification. Finally, we apply these methods to a randomized trial of the coronavirus disease 2019 mRNA-1273 vaccine. In this trial, VE NAI was higher than standard estimates of efficacy against asymptomatic infections and was similar in magnitude to efficacy against any infection. Reporting VE NAI in vaccine trials in addition to other vaccine effects would improve interpretability and could broaden understanding of vaccine impact on transmission, providing insights into immunological mechanisms.

226

News (Medical) associated with Nogapendekin alfa inbakicept-pmln

21 Oct 2026

·www.biospace.com

ImmunityBio Announces Database Lock for Registrational Trial of Locally Delivered, Chemotherapy-Free ANKTIVA® Plus BCG in BCG-Naïve Non-Muscle Invasive Bladder Cancer

Database lock completed for Cohort A of QUILT-2.005 (NCT02138734), a randomized, controlled registrational trial comparing ANKTIVA® plus BCG with BCG alone in 366 patients with BCG-naïve non-muscle invasive bladder cancer (NMIBC) ANKTIVA plus BCG is being evaluated as the first locally delivered, chemotherapy-free combination immunotherapy for BCG-naïve NMIBC Final analysis of the trial’s primary efficacy endpoint is underway, with topline results expected in November 2026 Supplemental Biologics License Application (sBLA) submission remains on track for the fourth quarter of 2026, potentially expanding ANKTIVA’s indication to include patients with BCG-naïve NMIBC earlier in their disease course CULVER CITY, Calif.--(BUSINESS WIRE)--ImmunityBio, Inc. (NASDAQ: IBRX), an immunotherapy company, today announced completion of the database lock for Cohort A of QUILT-2.005 (NCT02138734), its randomized, controlled, registrational trial evaluating ANKTIVA ® (nogapendekin alfa inbakicept-pmln) in combination with Bacillus Calmette-Guérin (BCG) versus BCG alone in patients with BCG-naïve NMIBC. The chemotherapy-free combination is delivered directly into the bladder. The database lock follows the completion of the data review, verification, and reconciliation of all 366 randomized patients, allowing the final efficacy analysis to proceed. The trial is designed to determine whether adding ANKTIVA to standard BCG therapy improves CR rates compared with BCG alone. An interim analysis requested by the U.S. Food and Drug Administration (FDA) demonstrated statistically significant longer duration of complete response with ANKTIVA plus BCG compared to BCG alone. With the database lock complete for all patients enrolled, the final analysis is now underway and will assess the trial’s primary endpoint and key secondary endpoints, including the duration of response, in accordance with the prespecified statistical analysis plan. ImmunityBio anticipates reporting topline results in November 2026 and remains on track to submit an sBLA to the FDA in the fourth quarter of 2026 for ANKTIVA plus BCG in patients with BCG-naïve NMIBC. Cohort A completed enrollment in February 2026, with 366 patients randomized to receive ANKTIVA plus BCG versus BCG alone. In March 2026, following a protocol-specified interim review of the data from 183 evaluable patients, the Independent Data Monitoring Committee (IDMC) determined that the enrolled population provided sufficient statistical power to detect the prespecified clinically meaningful difference between treatment arms, with no additional enrollment required. “QUILT-2.005 was designed to investigate whether, ANKTIVA, an IL-15 receptor agonist, could build upon the trained immunity induced by BCG by activating natural killer (NK) cells and CD8+ cytotoxic T cells with upregulating memory T cells to enhance therapeutic effectiveness earlier in the bladder cancer treatment journey,” 1,2 said Patrick Soon-Shiong, M.D., Founder, Executive Chairman and Global Chief Medical and Scientific Officer of ImmunityBio. “With the database lock now complete in this randomized trial of 366 patients, we are entering a critical phase of validating the important role an IL-15 superagonist plays in the next evolution of immunotherapy. It has been established that chemotherapeutic approaches for the treatment of bladder cancer result in a reduction of NK and T cells, lymphocytes that are important for durable responses. The final analysis of this study will determine whether adding ANKTIVA to BCG improves complete response rates and the durability of those responses when compared with BCG alone, potentially resulting in the first intravesical, chemotherapy-free treatment approach for patients with BCG-naïve NMIBC. We look forward to sharing the findings once the analysis is complete.” “Achieving database lock brings us another step closer to our planned sBLA submission and our goal of expanding chemotherapy-free treatment options for patients with NMIBC,” said Richard Adcock, President and Chief Executive Officer of ImmunityBio. “This progress reflects the coordinated efforts of our clinical development team, investigators, and site personnel across 110 U.S. and global clinical sites. We are especially grateful to the patients whose participation has made this important research possible.” About the QUILT-2.005 Study QUILT-2.005 (NCT02138734) is a randomized, controlled registrational trial comparing the intravesical chemotherapy-free combination of ANKTIVA ® (nogapendekin alfa inbakicept-pmln) with BCG versus BCG alone in patients with BCG-naïve NMIBC. BCG-naïve patients are those receiving BCG-based therapy for the first time, representing an earlier stage of treatment than the BCG-unresponsive population for which ANKTIVA is currently approved. Enrollment of Cohort A was completed in February 2026 with 366 randomized patients. Following a protocol-specified interim review in March 2026, the IDMC determined that no additional enrollment was required to maintain the study’s prespecified statistical power. Full details can be found on clinicaltrials.gov . About ANKTIVA ® (nogapendekin alfa inbakicept-pmln) The interleukin-15 (IL-15) cytokine plays a crucial role in the immune system by affecting the development, maintenance, and function of key immune cells, NK and CD8+ killer T cells, that are involved in killing cancer cells. By activating NK cells, ANKTIVA overcomes the tumor escape phase of clones resistant to T cells and restores memory T cell activity with resultant prolonged duration of complete response. ANKTIVA is a first-in-class IL-15 receptor agonist IgG1 fusion complex, consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15 receptor alpha, which binds with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells. This fusion complex of ANKTIVA mimics the natural biological properties of the membrane-bound IL-15 receptor alpha, delivering IL-15 independent of dendritic cells and driving the activation and proliferation of NK cells with the generation of memory killer T cells that have retained immune memory against these tumor clones. IMPORTANT SAFETY INFORMATION INDICATION AND USAGE: ANKTIVA ® is an interleukin-15 (IL-15) receptor agonist indicated in combination with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). WARNINGS AND PRECAUTIONS: Risk of Metastatic Bladder Cancer with Delayed Cystectomy. Delaying cystectomy can lead to the development of muscle-invasive or metastatic bladder cancer, which can be lethal. If patients with BCG-unresponsive NMIBC have evidence of high-grade disease after a second induction course of ANKTIVA ® with BCG, reconsider cystectomy. DOSAGE AND ADMINISTRATION: For Intravesical Use Only. Do not administer by subcutaneous or intravenous routes. USE IN SPECIFIC POPULATIONS: Pregnancy: May cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception. ADVERSE REACTIONS: The most common (≥15%) adverse reactions, including laboratory test abnormalities, are increased creatinine, dysuria, hematuria, urinary frequency, micturition urgency, urinary tract infection, increased potassium, musculoskeletal pain, chills, and pyrexia. For more information, please see the Prescribing Information for ANKTIVA ® at Anktiva.com . About ImmunityBio ImmunityBio, Inc. is a biotechnology company focused on innovating, developing, and commercializing next-generation immunotherapies designed to activate the patient’s immune system and deliver durable protection against cancer and infectious diseases. Our approach harnesses both the adaptive and innate immune systems with the goal of restoring immune function and generating lasting immunological memory in patients. At the core of our strategy is the Cancer BioShield ™ platform, which is designed to stimulate critical lymphocytes, including natural killer (NK) cells, cytotoxic T cells, and memory T cells via our proprietary IL-15 receptor agonist, ANKTIVA ® (nogapendekin alfa inbakicept-plmn). Our Cancer BioShield platform is anchored by this antibody-cytokine fusion protein and is complemented by a portfolio that includes adenovirus-vectored vaccines, allogeneic (off-the-shelf) and autologous NK-cell therapies, and additional immunomodulators intended to promote immunogenic cell death and support durable immune responses while potentially reducing reliance on high-dose chemo-radiation therapy. For more information, visit ImmunityBio.com and connect with us on X (Twitter), Facebook , LinkedIn , and Instagram . References: van Puffelen JH, et al., Trained immunity as a molecular mechanism for BCG immunotherapy in bladder cancer . Nat Rev Urol. 2020 Sep;17(9):513-525. doi: 10.1038/s41585-020-0346-4. Epub 2020 Jul 16. PMID: 32678343. ANKTIVA Mechanism of Action , Section 12.1 Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. All statements contained in this press release other than statements of historical fact, including statements regarding the anticipated timing of topline results from the QUILT-2.005 trial, the planned submission of a supplemental Biologics License Application (sBLA) for ANKTIVA ® (nogapendekin alfa inbakicept-pmln), and the potential clinical benefits of ANKTIVA ® in combination with BCG for patients with BCG-naïve NMIBC, are forward-looking statements. Forward-looking statements include, without limitation, statements regarding the Company’s expectations, beliefs, plans, objectives, strategies, prospects, and future performance relating to: the anticipated timing, conduct, and outcomes of the final analysis of Cohort A of the QUILT-2.005 trial; the planned submission of an sBLA to the FDA; the potential clinical benefits, safety profile, and efficacy of ANKTIVA ® in combination with BCG for BCG-naïve NMIBC; the significance and implications of the clinical trial results once analyzed and published; and the potential for ANKTIVA ® to address unmet medical needs in earlier lines of therapy. These forward-looking statements are based on the Company’s current expectations, estimates, forecasts, assumptions, and beliefs as of the date of this press release and involve known and unknown risks, uncertainties, assumptions, and other factors, many of which are outside the Company’s control, that could cause actual results, developments, performance, or achievements to differ materially from those expressed, implied, or anticipated by such statements. Such risks and uncertainties include, among others: the early and preliminary nature of clinical data; the possibility that interim or topline results from the QUILT-2.005 trial may change as additional data become available or as data are further analyzed; the risk that clinical trial results may not support regulatory approval or further development of ANKTIVA ® for BCG-naïve NMIBC; the risk that the timing for announcing topline results or submitting the sBLA may be delayed; the timing, outcome, and unpredictability of regulatory review by the FDA and other regulatory authorities; manufacturing and supply risks, competition from existing or future therapies; clinical experience that may differ from results observed in clinical trials; and that additional safety, efficacy or other product-related information, including adverse events or previously unidentified risks, may emerge from the final analysis of QUILT-2.005 or additional studies. More details about these and other risks that may impact ImmunityBio’s business are described under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (the SEC) on February 23, 2026, the Company’s Quarterly Report on Form 10-Q filed with the SEC on August 4, 2026, and in subsequent filings made by ImmunityBio with the SEC, which are available on the SEC’s website at . ImmunityBio cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date hereof. ImmunityBio does not undertake any duty to update any forward-looking statement or other information in this press release, except to the extent required by law. Contacts ImmunityBio Contacts: Investors Hemanth Ramaprakash, PhD, MBA ImmunityBio, Inc. +1 858-746-9289 Hemanth.Ramaprakash@ImmunityBio.com Media Sarah Singleton ImmunityBio, Inc. +1 415-290-8045 Sarah.Singleton@ImmunityBio.com

ImmunotherapyClinical ResultClinical Study

18 Oct 2026

·www.biospace.com

ImmunityBio Reports Phase 3 Data Showing 84% Cystectomy Avoidance at Three Years and Complete Responses Beyond 53 Months with ANKTIVA® Plus BCG in BCG-Unresponsive NMIBC With CIS, With or Without Papillary Tumors

Peer-reviewed publication reports long-term outcomes from the QUILT-3.032 study supporting durable disease control and bladder preservation CULVER CITY, Calif.--(BUSINESS WIRE)--ImmunityBio, Inc. ( NASDAQ: IBRX ), a commercial-stage immunotherapy company, today announced the publication of long-term data from the Phase 2/3 QUILT-3.032 study (N=100) in the Journal of Urology . The study evaluated ANKTIVA ® (nogapendekin alfa inbakicept-pmln) in combination with Bacillus Calmette-Guérin (BCG) in patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary disease. Highlights: 71% complete response (CR) rate in patients with BCG-unresponsive NMIBC CIS, with or without papillary disease Median duration of CR of 26.6 months, with responses extending beyond 53 months More than half of responding patients in the FDA-reviewed population maintained complete responses beyond 45 months 84% cystectomy-free survival at 36 months among responders 98.2% disease-specific survival at three years No Grade 4 or Grade 5 treatment-related adverse events reported “The QUILT-3.032 study represents one of the longest follow-up data sets in BCG-unresponsive NMIBC to date, and the results continue to support the durability of ANKTIVA’s unique mechanism of action in generating sustained immune responses,” said Patrick Soon-Shiong, M.D., Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio. “These long-term findings are encouraging, suggesting the potential for prolonged disease control and the possibility of avoiding or delaying radical cystectomy for some patients.” The publication also reported: 63.8% of responders maintained CR for at least 12 months 52.3% maintained CR for at least 24 months 44.2% maintained CR for at least 36 months Progression-free survival remained 80.9% at three years In BCG refractory (never responded) patients, the CR rate was 66% 4% of responders progressed to muscle-invasive disease The treatment continued to demonstrate a favorable safety profile. Most treatment-related adverse events were Grade 1 or Grade 2 and consisted of localized bladder symptoms associated with intravesical therapy. Grade 3 treatment-related adverse events occurred in 4% of patients, with no Grade 4 or Grade 5 treatment-related adverse events reported. “Achieving a durable response and avoiding cystectomy are important treatment goals for patients with BCG-unresponsive NMIBC,” said Richard Adcock, President and CEO of ImmunityBio. “These peer-reviewed results add to the growing body of evidence supporting ANKTIVA plus BCG and highlight its potential to provide sustained disease control and meaningful cystectomy avoidance for patients with limited treatment options. We thank the patients and clinical teams who contributed to this long-term follow-up.” The publication builds upon the growing body of clinical evidence supporting ANKTIVA plus BCG, which was initially approved by the U.S. Food and Drug Administration (FDA) in 2024 for the treatment of adult patients with BCG-unresponsive NMIBC with CIS, with or without papillary tumors. In October 2026, the FDA expanded the approved indication to include patients with BCG-unresponsive NMIBC with papillary-only disease. ANKTIVA is the first FDA-approved IL-15 receptor agonist and the first approved immunotherapy in NMIBC designed to activate natural killer (NK) cells and T cells to generate durable immune responses. About the QUILT 3.032 Study QUILT-3.032 (NCT03022825) is a multicenter Phase 2/3 study evaluating ANKTIVA plus BCG in patients with BCG-unresponsive NMIBC. The published analysis includes 100 patients with CIS with or without papillary disease and represents one of the longest follow-up datasets reported in this disease setting, with outcomes extending beyond five years in some patients. About ANKTIVA ® (nogapendekin alfa inbakicept-pmln) The interleukin-15 (IL-15) cytokine plays a crucial role in the immune system by affecting the development, maintenance, and function of key immune cells—NK and CD8+ killer T cells—that are involved in killing cancer cells. By activating NK cells, ANKTIVA ® overcomes the tumor escape phase of clones resistant to T cells and restores memory T cell activity with resultant prolonged duration of complete response. ANKTIVA ® is a first-in-class IL-15 receptor agonist IgG1 fusion complex, consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15 receptor alpha, which binds with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells. This fusion complex of ANKTIVA ® mimics the natural biological properties of the membrane-bound IL-15 receptor alpha, delivering IL-15 by dendritic cells and driving the activation and proliferation of NK cells with the generation of memory killer T cells that have retained immune memory against these tumor clones. IMPORTANT SAFETY INFORMATION INDICATION AND USAGE: ANKTIVA ® is an interleukin-15 (IL-15) receptor agonist indicated with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. WARNINGS AND PRECAUTIONS: Risk of Metastatic Bladder Cancer with Delayed Cystectomy. Delaying cystectomy can lead to the development of muscle-invasive or metastatic bladder cancer, which can be lethal. If patients with CIS do not have a complete response to treatment after a second induction course of ANKTIVA ® with BCG, reconsider cystectomy. DOSAGE AND ADMINISTRATION: For Intravesical Use Only. Do not administer by subcutaneous or intravenous routes. Please see the complete Indication and Important Safety Information and Prescribing Information for ANKTIVA ® at Anktiva.com . About ImmunityBio ImmunityBio, Inc. is a biotechnology company focused on innovating, developing, and commercializing next-generation immunotherapies designed to activate the patient’s immune system and deliver durable protection against cancer and infectious diseases. Our approach harnesses both the adaptive and innate immune systems with the goal of restoring immune function and generating lasting immunological memory in patients. At the core of our strategy is the Cancer BioShield ™ platform, which is designed to stimulate critical lymphocytes, including natural killer (NK) cells, cytotoxic T cells, and memory T cells via our proprietary IL-15 receptor agonist, ANKTIVA ® . Our Cancer BioShield platform is anchored by this antibody-cytokine fusion protein and is complemented by an investigational portfolio that includes adenovirus-vectored vaccines, allogeneic (off-the-shelf) and autologous NK-cell therapies, and additional immunomodulators intended to promote immunogenic cell death and support durable immune responses while potentially reducing reliance on high-dose chemo-radiation therapy. For more information, visit ImmunityBio.com and connect with us on X (Twitter), Facebook , LinkedIn , and Instagram . Forward Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements regarding: the potential for ANKTIVA ® plus BCG to provide prolonged disease control and bladder preservation; expectations regarding cystectomy avoidance and sustained complete responses in BCG-unresponsive NMIBC patients; future commercialization efforts and market acceptance of ANKTIVA; the potential expansion of indications or patient populations for ANKTIVA; future clinical development plans and regulatory submissions; and the potential benefits of ANKTIVA's mechanism of action and the Cancer BioShield™ platform. These forward-looking statements are based on the beliefs of ImmunityBio's management as well as assumptions made by and information currently available to ImmunityBio. Such statements reflect the current views of ImmunityBio with respect to future events and are subject to various risks, uncertainties, and assumptions. Actual results may differ materially from those described in these forward-looking statements due to a variety of factors, including: the risks that the long-term data from the QUILT 3.032 study may not be predictive of future results or real-world outcomes; challenges in commercializing ANKTIVA and achieving market acceptance; manufacturing and supply chain risks; competition from other therapies; the impact of reimbursement and pricing decisions by third-party payors; the risk of unexpected safety or efficacy findings; uncertainties regarding intellectual property protection; general economic and market conditions. More details about these and other risks that may impact ImmunityBio’s business are described under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on February 23, 2026, Quarterly Report on Form 10-Q filed with the SEC on August 4, 2026, and in subsequent filings made by ImmunityBio with the SEC, which are available on the SEC’s website at . ImmunityBio cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date hereof. ImmunityBio does not undertake any duty to update any forward-looking statement or other information in this press release, except to the extent required by law. Contacts ImmunityBio Contacts: I nvestors Hemanth Ramaprakash, PhD, MBA ImmunityBio, Inc. +1 858-746-9289 Hemanth.Ramaprakash@ImmunityBio.com Media Sarah Singleton ImmunityBio, Inc. +1 415-290-8045 Sarah.Singleton@ImmunityBio.com

Clinical ResultImmunotherapyPhase 3Drug Approval

15 Oct 2026

·www.biospace.com

FDA Expands ANKTIVA® Approval for BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer to Cover Both Papillary and CIS Disease

Expanded indication extends ANKTIVA plus BCG to patients with BCG-unresponsive non-muscle-invasive bladder cancer (NMIBC), including those with carcinoma in situ (CIS), with or without papillary tumors, and those with papillary-only tumors Papillary disease represents approximately 85% of the NMIBC patient population 1 This is the first FDA approval to include BCG-unresponsive NMIBC with papillary-only tumors With this FDA approval, access to ANKTIVA plus BCG expands to include all patients with BCG-unresponsive NMIBC CULVER CITY, Calif.--(BUSINESS WIRE)--ImmunityBio, Inc. (NASDAQ: IBRX), a commercial-stage immunotherapy company, today announced that the U.S. Food and Drug Administration (FDA) has expanded the approved indication for ANKTIVA ® (nogapendekin alfa inbakicept-pmln) in combination with Bacillus Calmette-Guérin (BCG) to include patients with BCG-unresponsive NMIBC with papillary-only tumors. The expanded FDA label reads as follows: ANKTIVA, in combination with Bacillus Calmette-Guérin (BCG), is indicated for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer. 2 The broadened indication builds on the FDA’s April 2024 approval of ANKTIVA plus BCG for patients with BCG-unresponsive NMIBC with carcinoma in situ (CIS), 3 with or without papillary tumors. CIS and papillary tumors are aggressive and associated with high risk of recurrence and progression in the BCG-unresponsive setting. This is the first FDA approval to include BCG-unresponsive NMIBC with papillary-only tumors. “This approval marks an important expansion of ANKTIVA plus BCG for patients with BCG-unresponsive NMIBC and advances our goal of harnessing the patient’s own immune system to achieve durable, tumor-free outcomes,” said Dr. Patrick Soon-Shiong, Founder, Executive Chairman, and Global Chief Scientific and Medical Officer of ImmunityBio. “An important first step as we develop Immunotherapy 2.0.” The expanded approval is based on the FDA’s review of available scientific information, including the previously demonstrated efficacy of ANKTIVA plus BCG in patients with BCG-unresponsive NMIBC with CIS, with or without papillary tumors. In Cohort A of the QUILT-3.032 trial, 62% of 77 patients achieved a complete response (95% CI: 51, 73); among responders, 58% maintained a response for at least 12 months and 40% for at least 24 months. 4 The combination of ANKTIVA plus BCG has a tolerable safety profile, with the most common treatment-related adverse events (TRAEs) related to bladder instillation (e.g., dysuria, pollakiuria, and hematuria), and most of these TRAEs were grade 1 to 2. This is consistent with the side effects of BCG alone. 4 The prescribing information includes a warning that delaying cystectomy can lead to the development of metastatic bladder cancer, which can be lethal. 2 Expanding Treatment Options for BCG-Unresponsive NMIBC Bladder cancer has among the most expensive cancers to treat over a patient’s lifetime , reflecting the substantial costs associated with ongoing surveillance, treatment, and disease management. 5 NMIBC accounts for approximately 80% of all bladder cancer diagnoses in the U.S. and includes both CIS and papillary tumors. 6 An estimated 85% to 90% of patients diagnosed with NMIBC present with papillary disease . 7 Patients with high-grade papillary disease that becomes unresponsive to BCG face an increased risk of recurrence and progression and often have limited nonsurgical treatment options. “Patients with high-grade papillary disease that no longer responds to BCG remain at meaningful risk for recurrence and progression and historically have had limited nonsurgical treatment options,” said Sam S. Chang, M.D., Professor of Urology and Chief Surgical Officer of the Vanderbilt Ingram Cancer Center. “The availability of an FDA-approved treatment for this population represents an important addition to the treatment landscape, providing appropriate patients with BCG-unresponsive disease another treatment option that may help preserve the bladder.” ANKTIVA’s expansion into BCG-unresponsive high-grade papillary-only NMIBC significantly increases its U.S. addressable patient population beyond the currently approved CIS with or without papillary indication. “The expansion of ANKTIVA plus BCG into papillary-only disease broadens the eligible patient population and establishes it as the first FDA-approved therapy for both CIS and papillary-only disease in BCG-unresponsive NMIBC,” added Richard Adcock, President and CEO of ImmunityBio. “Building on strong commercial growth since ANKTIVA’s initial approval, we remain focused on helping eligible patients access this therapy and are grateful to the patients, families, investigators, and clinical teams who made this progress possible.” About ANKTIVA ® (nogapendekin alfa inbakicept-pmln) The interleukin-15 (IL-15) cytokine plays a crucial role in the immune system by affecting the development, maintenance, and function of key immune cells, NK and CD8+ killer T cells, that are involved in killing cancer cells. By activating NK cells, ANKTIVA overcomes the tumor escape phase of clones resistant to T cells and restores memory T cell activity with resultant prolonged duration of complete response. ANKTIVA is a first-in-class IL-15 receptor agonist IgG1 fusion complex, consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15 receptor alpha, which binds with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells. This fusion complex of ANKTIVA mimics the natural biological properties of the membrane-bound IL-15 receptor alpha, delivering IL-15 independent of dendritic cells and driving the activation and proliferation of NK cells with the generation of memory killer T cells that have retained immune memory against these tumor clones. IMPORTANT SAFETY INFORMATION INDICATION AND USAGE: ANKTIVA ® is an interleukin-15 (IL-15) receptor agonist indicated in combination with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive nonmuscle invasive bladder cancer (NMIBC). WARNINGS AND PRECAUTIONS: Risk of Metastatic Bladder Cancer with Delayed Cystectomy. Delaying cystectomy can lead to the development of muscle-invasive or metastatic bladder cancer, which can be lethal. If patients with BCG-unresponsive NMIBC have evidence of high-grade disease after a second induction course of ANKTIVA ® with BCG, reconsider cystectomy. DOSAGE AND ADMINISTRATION: For Intravesical Use Only. Do not administer by subcutaneous or intravenous routes. USE IN SPECIFIC POPULATIONS: Pregnancy: May cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception. ADVERSE REACTIONS: The most common (≥15%) adverse reactions, including laboratory test abnormalities, are increased creatinine, dysuria, hematuria, urinary frequency, micturition urgency, urinary tract infection, increased potassium, musculoskeletal pain, chills, and pyrexia. For more information, please see the Prescribing Information for ANKTIVA ® at ANKTIVA.COM . About ImmunityBio ImmunityBio, Inc. is a biotechnology company focused on innovating, developing, and commercializing next-generation immunotherapies designed to activate the patient’s immune system and deliver durable protection against cancer and infectious diseases. Our approach harnesses both the adaptive and innate immune systems with the goal of restoring immune function and generating lasting immunological memory in patients. At the core of our strategy is the Cancer BioShield ™ platform, which is designed to stimulate critical lymphocytes, including natural killer (NK) cells, cytotoxic T cells, and memory T cells via our proprietary IL-15 receptor agonist, ANKTIVA ® (nogapendekin alfa inbakicept). Our Cancer BioShield platform is anchored by this antibody-cytokine fusion protein and is complemented by a portfolio that includes adenovirus-vectored vaccines, allogeneic (off-the-shelf) and autologous NK-cell therapies, and additional immunomodulators intended to promote immunogenic cell death and support durable immune responses while potentially reducing reliance on high-dose chemo-radiation therapy. For more information, visit ImmunityBio.com and connect with us on X (Twitter), Facebook , LinkedIn , and Instagram . References Anastasiadis A, de Reijke TM. Best practice in the treatment of nonmuscle invasive bladder cancer. Ther Adv Urol. 2012 Feb;4(1):13-32. doi: 10.1177/1756287211431976. PMID: 22295042; PMCID: PMC3263923. Available at U.S. Food and Drug Administration (FDA). FDA approves nogapendekin alfa inbakicept-pmln for BCG-unresponsive nonmuscle invasive bladder cancer. U.S. FDA April 2024. Chang SS, et al. J Urol. 2026;215(1):44–56. doi:10.1097/JU.0000000000004782. Mossanen M, Gore JL. The burden of bladder cancer care: direct and indirect costs. Curr Opin Urol. 2014;24(5):487–491. doi:10.1097/MOU.0000000000000078. PubMed Central. . Song J, et al. Contemporary data on incidence, treatments and outcomes of high-grade NMIBC in the US. Presented at: New England AUA Annual Meeting; 2019. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. All statements contained in this press release other than statements of historical fact, including statements regarding the potential benefits, commercial opportunities, market potential, and anticipated impact of the U. S. Food and Drug Administration’s approval of the expanded indication for ANKTIVA ® (nogapendekin alfa inbakicept-pmln) are forward-looking statements. Forward-looking statements include, without limitation, statements regarding the Company’s expectations, beliefs, plans, objectives, strategies, prospects, and future performance relating to: the potential clinical benefits, safety, effectiveness, utility, and therapeutic value of ANKTIVA ® for patients within the newly approved indication; the potential for ANKTIVA ® to address unmet medical needs, improve patient outcomes, or become an important treatment option or standard of care; the size and characteristics of the patient population eligible for treatment; the potential market opportunity and commercial potential associated with the expanded indication; the anticipated timing, scope, effectiveness, and success of the Company’s commercialization, promotional, marketing, medical affairs, market access, and product launch activities; the anticipated adoption, utilization, prescribing patterns, and acceptance of ANKTIVA ® by physicians, patients, healthcare providers, payors, and other stakeholders; the Company’s ability to obtain, maintain, or expand adequate coverage, reimbursement, formulary access, and favorable pricing for ANKTIVA ® ; the anticipated effect of the expanded indication on product demand, sales, revenue, profitability, cash flows, financial condition, and future operating results; the Company’s ability to manufacture, supply, distribute, and commercialize sufficient quantities of ANKTIVA ® to meet anticipated demand; the potential competitive positioning of ANKTIVA ® relative to existing and future treatment alternatives; and the Company’s plans and expectations concerning additional clinical development, regulatory submissions, label expansions, lifecycle management, and other potential opportunities for ANKTIVA ® . These statements may be identified by words such as "aim," "anticipate," "believe," "contemplate," "could," "estimate," "expect," "forecast," "goal," "intend," "may," "plan," "possible," "potential," "predict," "project," "seek," "should," "strive," "target," "will," "would," and similar expressions. These forward-looking statements are based on the Company’s current expectations, estimates, forecasts, assumptions, and beliefs as of the date of this press release and involve known and unknown risks, uncertainties, assumptions, and other factors, many of which are outside the Company’s control, that could cause actual results, developments, performance, or achievements to differ materially from those expressed, implied, or anticipated by such statements. Such risks and uncertainties include, among others: the possibility that the expanded indication for ANKTIVA ® will not result in the anticipated levels of physician adoption, patient utilization, market penetration, product demand, or commercial success; that the actual number of patients eligible for or receiving treatment may be smaller than anticipated; that physicians, patients, treatment guidelines, healthcare institutions, or payors may not adopt or support use of ANKTIVA ® to the extent or within the time frames anticipated; that clinical experience following approval may differ from results observed in clinical trials; that additional safety, tolerability, efficacy, or other product-related information, including adverse events or previously unidentified risks, may emerge through post-marketing surveillance, real-world use, or additional studies; and that the Company may encounter unexpected challenges in complying with ongoing regulatory requirements, including those governing manufacturing, product quality, pharmacovigilance, advertising, promotion, and commercialization. Additional risks and uncertainties include: the Company’s ability to successfully execute its commercial strategy for the expanded indication; the effectiveness of its sales force, marketing initiatives, medical education efforts, distribution arrangements, and other commercialization activities; limitations on the Company’s ability to promote ANKTIVA ® outside its approved labeling; the availability, scope, timing, and adequacy of coverage and reimbursement from Medicare, Medicaid, commercial insurers, and other third-party payors; pricing pressures, rebates, discounts, utilization management restrictions, prior authorization requirements, and changes in healthcare laws, regulations, and reimbursement policies; the impact of federal and state drug pricing initiatives and other healthcare cost-containment measures; competition from currently marketed products, newly approved therapies, generic products, biosimilars, and other existing or emerging treatment modalities; changes in clinical practice guidelines or treatment paradigms; the ability of the Company and its third-party manufacturers and suppliers to maintain adequate manufacturing capacity, product quality, inventory levels, and reliable supply chains; manufacturing deviations, quality-control issues, product shortages, recalls, or disruptions in distribution; and the Company’s ability to protect, maintain, and enforce intellectual property rights, regulatory exclusivities, and other proprietary rights relating to ANKTIVA ® . More details about these and other risks that may impact ImmunityBio’s business are described under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on February 23, 2026, Quarterly Report on Form 10-Q filed with the SEC on August 4, 2026, and in subsequent filings made by ImmunityBio with the SEC, which are available on the SEC’s website at . ImmunityBio cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date hereof. ImmunityBio does not undertake any duty to update any forward-looking statement or other information in this press release, except to the extent required by law. Contacts ImmunityBio Contacts: I nvestors Hemanth Ramaprakash, PhD, MBA ImmunityBio, Inc. +1 858-746-9289 Hemanth.Ramaprakash@ImmunityBio.com Media Sarah Singleton ImmunityBio, Inc. +1 415-290-8045 Sarah.Singleton@ImmunityBio.com

ImmunotherapyDrug ApprovalClinical ResultClinical StudyRadiation Therapy

100 Deals associated with Nogapendekin alfa inbakicept-pmln

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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
metastatic non-small cell lung cancer	Saudi Arabia	ImmunityBio, Inc.	21 Apr 2026
Carcinoma in Situ	European Union	ImmunityBio, Inc.	16 Feb 2026
Carcinoma in Situ	Iceland	ImmunityBio, Inc.	16 Feb 2026
Carcinoma in Situ	Liechtenstein	ImmunityBio, Inc.	16 Feb 2026
Carcinoma in Situ	Norway	ImmunityBio, Inc.	16 Feb 2026
Non-Muscle Invasive Bladder Urothelial Carcinoma	Saudi Arabia	ImmunityBio, Inc.	14 Jan 2026
Lymphopenia	United States	ImmunityBio, Inc.	02 Jun 2025
Non-Muscle Invasive Bladder Neoplasms	United States	Altor BioScience Corp.	22 Apr 2024

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Community Acquired Pneumonia	Phase 3	-	ImmunityBio, Inc.	15 Apr 2026
Respiratory Distress Syndrome, Acute	Phase 3	-	ImmunityBio, Inc.	15 Apr 2026
Sepsis	Phase 3	-	ImmunityBio, Inc.	15 Apr 2026
Shock, Septic	Phase 3	-	ImmunityBio, Inc.	15 Apr 2026
Lung Cancer	Phase 3	United States	ImmunityBio, Inc.	27 Jul 2022
Advanced Lung Non-Small Cell Carcinoma	Phase 3	United States	ImmunityBio, Inc.	18 May 2018
Bladder Cancer	Phase 3	United States	ImmunityBio, Inc.	02 Jun 2017
HPV positive oropharyngeal squamous cell carcinoma	Phase 2	-	ImmunityBio, Inc.	22 Jul 2026
HPV16 positive Oropharyngeal Cancer	Phase 2	-	ImmunityBio, Inc.	22 Jul 2026
Recurrent Glioblastoma	Phase 2	-	ImmunityBio, Inc.	22 Jul 2026

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06745908 (ResQ201A, ESMO2026)	Phase 3	Maintenance	298	NAI + CPI + induction docetaxel	arvsaldrrh(fatsbdiwiw) = qsikpjwcym etllatvekj (dusewufhvq, 51 - 80)	Positive	23 Oct 2026
				docetaxel	omwdabopko(shfdtlvzcx) = uzlhnnstih zwvjcfqxsd (jcmecuyugi, 9 - 21)
NCT06061809 (QUILT-3.078, ESMO2026)	Phase 2	Recurrent Glioblastoma	36	NAI, PD-L1 t-haNK, and BEV	scribsjlwi(beedcaqfzv) = wlcxkuupaz sxgitahedr (rnopfjhdlw ) View more	Positive	23 Oct 2026
NCT03228667 (QUILT-3.055, ESMO2026)	Phase 2	Advanced Malignant Solid Neoplasm lymphocyte count \| neutrophil-lymphocyte ratio	147	nogapendekin alfa inbakicept (NAI)+checkpoint inhibitor (ALC responders)	bscpwrgxso(reakudhlvb) = mlicwlxmzt smpnapioor (dvlgmwhsja ) View more	Positive	23 Oct 2026
				NAI+CPI (non-responders)	behrsatvan(xuctdnjwkw) = arfzscajkf yrtcsqifyn (baaecnaswg )
NCT02782546 (CTgov)	Phase 2	Acute Myeloid Leukemia \| Refractory acute myeloid leukemia	60	G-CSF+ALT-803+Tacrolimus+mycophenolate mofetil+CIML NK cell infusion (Recipient)	ltwuoiyxbn = bpktreyxyv iiegwylxih (bzkukzwful, ysbwrkyisb - xgdhstmacl) View more	-	01 Jun 2026
				Leukapheresis (Donor)	zzqrycynmm(yweayqkbqm) = pfclnipuyd gnmvmswbsr (wucvyltiwb, ffnrgvanbe - ldnjtkzuwj) View more
NCT03520686 (QUILT-2.023, ASCO2026)	Phase 3	Non-Small Cell Lung Cancer First line PD-L1 TPS	98	CPI+NAI	uoxijdsvhl(etdtymjlvb) = zkoazymdyu safrazagdi (pfkahzbuts ) View more	Positive	29 May 2026
				CPI	uoxijdsvhl(etdtymjlvb) = mlagjnbmte safrazagdi (pfkahzbuts ) View more
NCT03022825 (QUILT-3.032, ASCO2026)	Phase 3	Non-Muscle Invasive Bladder Neoplasms	173	nogapendekin alfa inbakicept-pmln + BCG (NAI+BCG)	zaoejseynk(wvlleevngh) = zwmkgfmovr zwktjeswgd (mlynnzbhyr ) View more	Positive	29 May 2026
				pembrolizumab (PEMBRO)	zaoejseynk(wvlleevngh) = tslikliile zwktjeswgd (mlynnzbhyr ) View more
NCT05419011 (TRIAD5-Plus, Pubmed \| Front Immunol)	Phase 2	Hereditary Nonpolyposis Colorectal Cancer Lynch syndrome	158	Tri-Ad5	dvuyhggqyu(qpnrjvvjib) = zbccafuavj kgkuebyhga (evjxwolimk )	Positive	19 May 2026
				Tri-Ad5 + NAI	dvuyhggqyu(qpnrjvvjib) = mjgodwibfo kgkuebyhga (evjxwolimk )
Keynote-057 (AUA2026)	Phase 2	Bladder Cancer CIS+	296	pembrolizumab (carcinoma in situ (CIS) and BCG-unresponsive)	rjzxruipaz(rivbfdjsuc) = wpcabeilns pbicjqjaon (iciravjqar, 14.7 - 31.9) View more	Positive	15 May 2026
				nadofarogene (carcinoma in situ (CIS) and BCG-unresponsive)	rjzxruipaz(rivbfdjsuc) = etrafwgnvh pbicjqjaon (iciravjqar, 21.8 - 39.4)
NCT06745908 (ResQ201A, ESMO_ELCC2026)	Phase 3	-	462	NAI+tislelizumab+docetaxel	fgqqcaawym(jlyqajgxjg) = gntwhcxqay odggkvsxec (lmgcbzvacz ) View more	Positive	25 Mar 2026
				docetaxel	fgqqcaawym(jlyqajgxjg) = olgfevkefi odggkvsxec (lmgcbzvacz ) View more
NCT02523469 (CTgov)	Phase 1/2	metastatic non-small cell lung cancer	67	ALT-803+Nivolumab (Cohort 1: ALT-803 6 µg/kg + Nivolumab 3 mg/kg)	hkhkjhvgbl = smkbjljutq pvgpufiqjy (ocgiarecyn, vksbzinodq - thiffrnseb) View more	-	17 Feb 2026
				ALT-803+Nivolumab (Cohort 2: ALT-803 10 µg/kg + Nivolumab 3 mg/kg)	hkhkjhvgbl = hmmpnmfybo pvgpufiqjy (ocgiarecyn, ybtqdesziz - hwggxctawz) View more

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