AXL inhibitors(AXL receptor tyrosine kinase inhibitors), RET inhibitors(Tyrosine-protein kinase receptor RET inhibitors), ROS1 inhibitors(Proto-oncogene tyrosine-protein kinase ROS inhibitors)

Therapeutic Areas

NeoplasmsDigestive System DisordersEndocrinology and Metabolic Disease+ [11]

Active Indication

Neuroendocrine TumorsWell Differentiated Pancreatic Endocrine TumorExtra-pancreatic neuroendocrine tumor+ [180]

Inactive Indication

Advanced Bile Duct CarcinomaAdvanced breast cancerAdvanced Nasopharyngeal Carcinoma+ [58]

Originator Organization

Exelixis, Inc.

Active Organization

Exelixis, Inc.Hoffmann-La Roche, Inc.

University of Utah

+ [21]

Inactive Organization

Rps Medical Technology (Beijing) Co Ltd

University of Washington

Jiangsu Hansoh Pharmaceutical Group Co., Ltd.

+ [2]

License Organization

Ipsen SA

Takeda Pharmaceutical Co., Ltd.

Chugai Pharmaceutical Co., Ltd.

+ [7]

Drug Highest PhaseApproved

First Approval Date

United States (29 Nov 2012),

Thyroid Cancer, Medullary

RegulationPriority Review (United States), Breakthrough Therapy (United States), Fast Track (United States), Orphan Drug (United States)

Structure/Sequence

Molecular FormulaC32H30FN3O10

InChIKeyHFCFMRYTXDINDK-WNQIDUERSA-N

CAS Registry1140909-48-3

294

Clinical Trials associated with Cabozantinib (s)-Malate

NCT07848295

/ Not yet recruitingPhase 1

A Phase 1, Multicenter, Open-label, Study of BMS-986527, Healthy Donor Allogeneic CD70-targeted Chimeric Antigen Receptor (CAR) T Cells, as Monotherapy or in Novel Combinations in Participants With Clear Cell Renal Cell Carcinoma (ccRCC)

The purpose of this study is to assess the safety and tolerability of BMS-986527 in participants with Clear Cell Renal Cell Carcinoma (ccRCC)

Start Date31 Dec 2026

Sponsor / Collaborator

Juno Therapeutics, Inc.

[+1]

CTRI/2026/09/118492

/ Not yet recruitingNot Applicable

An Open Label Balanced Randomized Single Dose Two Treatment Two Sequence Four Period Fully Replicate Reference Scaled Average Truncated Oral Bioequivalence Study Comparing Cabozantinib Fumarate Salt Tablets 60mg Manufactured by BDR Pharmaceuticals International Pvt Ltd India With Cabometyx 60 mg Film Coated Tablets Cabozantinib Marketing Authorisation Holder Ipsen Pharma 70 Rue Balard 75015 Paris France in healthy males not of reproductive potential ie surgically sterile and females not of reproductive potential trial participants under fasting conditions - NIL

Start Date15 Oct 2026

Sponsor / Collaborator

BDR Pharmaceuticals International Pvt Ltd.

NCT07871864

/ RecruitingPhase 3IIT

FOSTER Evolving Study Platform

This clinical study is the initiative of the FOSTER (Fight OsteoSarcoma Through European Research) consortium and Gustave Roussy, which is the sponsor. Its aim is to evaluate the biology of tumour in greater depth by collecting samples of the tumour during the biopsy at diagnosis, and blood samples. This study is a platform study that evolves over time. This means that it allows for the evaluation of several treatments or therapeutic strategies within a single clinical trial, which can be modified and adapted over time.
The FOSTER evolving study platform aim to implement a comprehensive strategy of clinical, biological, radiological, therapeutic integrated research from diagnosis to relapse, with the aim to improve survival of osteosarcoma patients of all age, through randomised therapeutic questions at different phase of treatment from diagnosis to relapse. The platform study makes it possible to evaluate several treatments for the same disease, on an ongoing basis, using a main protocol with adaptable arms.
The FOSTER-CabOS trial (part 2 of FOSTER study) is a European Phase III clinical study . It assesses the efficacy of cabozantinib, a tyrosine kinase inhibitor, as a maintenance therapy post-standard treatment in osteosarcoma patients. The trial is randomized against Best Supportive Care to determine the effectiveness of cabozantinib in improving event-free survival. This maintenance therapy aims to prevent relapse among patients who have already received standard treatment for osteosarcoma.

Start Date01 Oct 2026

Sponsor / Collaborator

Gustave Roussy, Cancer Campus, Grand Paris

[+6]

100 Clinical Results associated with Cabozantinib (s)-Malate

100 Translational Medicine associated with Cabozantinib (s)-Malate

100 Patents (Medical) associated with Cabozantinib (s)-Malate

2,363

Literatures (Medical) associated with Cabozantinib (s)-Malate

31 Dec 2026·OncoImmunology

Efficacy and safety of cabozantinib plus nivolumab in advanced non-clear cell renal cell carcinoma: a nationwide multicenter study

Article

Author: Shin, Sang Joon ; Park, Ji Hyun ; Kim, Eo Jin ; Im, Hyeon-Su ; Kim, Chang Gon ; Kang, Byung Woog ; Park, Inkeun ; Jung, Eun Hee ; Kim, Junkyu ; Jo, Jungmin ; Park, Se Hoon ; Kim, In-Ho ; Kim, Se Hyun ; Lee, Jae-Lyun ; Beom, Seung Hoon ; Rha, Sun Young ; Park, Joo-Hwan

Non-clear cell renal cell carcinoma (nccRCC) represents a biologically heterogeneous group of tumors for which optimal systemic treatment strategies remain poorly defined despite recent therapeutic advances. To address this gap, we evaluated the clinical activity and safety of cabozantinib plus nivolumab in patients with advanced nccRCC. In this nationwide, multicenter retrospective cohort study conducted in the Republic of Korea, 62 patients received the combination across multiple lines of therapy, with most treated in the first-line setting. Papillary RCC was the most common histologic subtype (50.0%), followed by FH-deficient (22.6%), TFE3-rearranged (9.7%), chromophobe (6.5%), collecting duct (6.5%), and unclassified tumors (4.8%). With a median follow-up of 22.2 months (95% confidence interval [CI], 15.4-29.1), the objective response rate (ORR) was 45.2% (95% CI, 32.4-57.9) and the disease control rate (DCR) was 93.6% (95% CI, 87.3-99.8). Responses were seen across histologic subtypes (ORR = 48.4% in papillary, 50.0% in FH-deficient, 50.0% in TFE3-rearranged, 25.0% in chromophobe, 25.0% in collecting duct, and 33.3% in unclassified tumors; P = 0.876). Median progression-free and overall survival were 9.7 months (95% CI, 7.7-11.6) and 22.0 months (95% CI, 15.2-28.7), respectively. Grade 3-4 treatment-emergent adverse events occurred in 46.8% of patients, and treatment discontinuation due to toxicity was reported in 6.5%. These findings demonstrate that cabozantinib plus nivolumab provides clinically meaningful and durable antitumor activity with manageable toxicity across diverse histologic subtypes in advanced nccRCC, supporting further prospective evaluation of cabozantinib plus nivolumab in advanced nccRCC.

31 Dec 2026·Human Vaccines & Immunotherapeutics

Cost‑effectiveness of first‑line immunotherapy-based combination regimens for advanced renal cell carcinoma in China and the United States

Article

Author: Yan, Chunyan ; Zhao, Quan ; Li, Jiayan ; Diao, Ruigang ; Gao, Yuan ; Li, Zhengxiong

Immunotherapy‑based combination regimens provide significant clinical benefits but impose substantial economic burdens on national healthcare systems. This study assessed the cost-effectiveness of immunotherapy‑based combination regimens as first-line treatments for advanced renal cell carcinoma (aRCC) in China and the United States (US). A partitioned survival model was developed to evaluate the cost-effectiveness of all approved regimens with a lifetime horizon. The primary outcomes were total costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs). Sensitivity analyses were performed to evaluate model uncertainty. Compared to the sunitinib regimen, the ICERs for the toripalimab plus axitinib (T + A), nivolumab plus ipilimumab (N + I), lenvatinib plus pembrolizumab (L + P), pembrolizumab plus axitinib (P + A), nivolumab plus cabozantinib (N + C), avelumab plus axitinib (A + A) and atezolizumab plus bevacizumab (A + B) regimens in China were $64,536.98/QALY, $135,593.25/QALY, $174,956.58/QALY, $231,908.95/QALY, $728,876.75/QALY, $1,232,070.43/QALY, and $2,496,799.42/QALY, respectively. The ICERs for the N + I, T + A, N + C, P + A, L + P, A + A, and A + B regimens in the US were $160,243.50/QALY, $468,156.65/QALY, $804,963.69/QALY, $907,549.79/QALY, $2,170,769.66/QALY, $2,623,809.39/QALY, and $12,712,147.95/QALY, respectively. Probabilistic sensitivity analyses indicated that the probability of cost-effectiveness corresponding to N + I vs. sunitinib was 33.6% in the US. In China and the US, none of the seven first-line immunotherapy-based combination regimens was cost-effective compared with sunitinib for aRCC.

01 Dec 2026·EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES

Novel inhibitors of BCRP found among drugs used in the treatment of cancer

Article

Author: Deng, Feng ; Niemi, Mikko ; Tornio, Aleksi ; Hirvensalo, Päivi ; Filppula, Anne M ; Timonen, Martina

Breast cancer resistance protein (BCRP) is an ATP-binding cassette transporter involved in clinically relevant drug-drug interactions. We aimed to identify new BCRP inhibitors among drugs used in cancer treatment. Accordingly, 133 drugs were screened at 50 µM for inhibition of BCRP using vesicular transport assay. Half-maximal inhibitory concentrations (IC₅₀) were predicted, and compounds showing the highest inhibitory potencies relative to their systemic (I₁) or intestinal (I₂) concentrations were selected for experimental IC₅₀ determination. A mechanistic static model was used to predict potential interactions with the BCRP substrate rosuvastatin in humans. Food and Drug Administration Adverse Event Reporting System (FAERS) was searched for signals of rosuvastatin-induced rhabdomyolysis during co-administration with the investigated drugs. Of the 133 drugs screened, 42 had a predicted IC₅₀ value over 0.1 × I₁ and 61 over 10 × I₂, suggesting potential inhibition in humans. IC₅₀ values were experimentally determined for 24 selected drugs. Cabozantinib and midostaurin were the strongest inhibitors, with IC₅₀ values of 0.65 and 0.69 µM, respectively. Moreover, the model suggested that midostaurin, cabozantinib, and alpelisib could almost fully inhibit intestinal BCRP, nearly doubling rosuvastatin exposure (1.83- to 1.94-fold). Entrectinib, alpelisib, flutamide, abiraterone, and capecitabine were predicted to increase rosuvastatin exposure by 1.45- to 1.63-fold through BCRP inhibition. FAERS analysis indicated a higher frequency of rhabdomyolysis reports when abiraterone was co-administered with rosuvastatin compared with all reports without abiraterone, with a reporting odds ratio of 17.3. This study identified multiple previously unrecognized BCRP inhibitors, highlighting the potential for clinically relevant BCRP‑mediated drug-drug interactions in oncology patients.

614

News (Medical) associated with Cabozantinib (s)-Malate

20 Oct 2026

·www.biospace.com

Arcus Presents New Data from ARC-20 that Demonstrate the Opportunity for Casdatifan to Become a Foundational Treatment Across All Lines of Therapy in Kidney Cancer

Progression-free survival (PFS) for casdatifan plus anti-PD-1 in the first-line (1L) setting exceeded third-party benchmarks* for the approved anti-PD-1 plus anti-CTLA-4 regimen (ipilimumab plus nivolumab) and is similar to benchmarks for approved anti-PD-1 plus TKI regimens; the Phase 3 PEAK-20 study evaluating casdatifan plus ipilimumab and nivolumab is on track to start by year-end. PFS and overall survival (OS) in the second-line (2L) cohort evaluating casdatifan plus cabozantinib substantially exceeded benchmarks for cabozantinib monotherapy, including in patients who had previously progressed on TKIs; the ongoing Phase 3 PEAK-1 study is evaluating the same combination in the same patient population. An unprecedented nearly three-year median OS was reached in heavily pre-treated kidney cancer patients (majority third-line plus [3L+]) in the pooled monotherapy cohorts, exceeding the benchmark for the only approved HIF-2α inhibitor by more than one year; these data reinforce the potential for robust and durable HIF-2α inhibition to deliver a survival benefit across lines of therapy and support plans for a registrational trial to evaluate the combination of casdatifan plus tivozanib. HAYWARD, Calif.--(BUSINESS WIRE)--Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for the treatment of cancer and immune diseases, announced new data at an investor event in New York City from the ARC-20 platform study, which is evaluating casdatifan, an investigational next-generation HIF-2α inhibitor, alone or in combination, as a first-, second- and late-line treatment for clear cell renal cell carcinoma (ccRCC). “Across the RCC treatment continuum, and in every setting in which it has been studied, casdatifan has shown rapid disease control, a meaningful impact on survival, and was tolerable, both alone and in combination with standard-of-care therapies,” said Dr. Rana McKay, professor of medicine, urology, and radiation medicine, associate director of clinical sciences, at the UC San Diego Moores Cancer Center. “These are the attributes that matter most to physicians and patients.” “We are executing on a plan to develop casdatifan as a backbone therapy for all ccRCC patients,” said Richard Markus, M.D., Ph.D., chief medical officer at Arcus Biosciences. “The disease control that has been observed for casdatifan plus anti-PD-1 in the first line, the remarkable benefit that has been observed for patients in the second line, even after progressing on prior TKI treatment, and unprecedented three-year median overall survival from casdatifan monotherapy in patients who had progressed on multiple prior therapies reveal for the first time the potential associated with deep and durable HIF-2α inhibition. We are on track to initiate our second registrational trial in ccRCC, the first-line PEAK-20 study, by the end of this year. This study is enabled by the strong dataset we have generated in the first-line setting.” New data were presented from several cohorts of the ARC-20 study, which showed that every patient has the opportunity to benefit from casdatifan across each line of therapy over the course of their care. All cohorts had a data cut-off (DCO) of Sept. 4, 2026, and the data are summarized below. A detailed analysis can be accessed in a corporate deck published on the company’s website. First-line TKI-free combinations: Casdatifan plus anti-PD-1 zimberelimab (11.5 months of median follow-up) Landmark PFS values of 86% and 69% were observed at 6 and 12 months, respectively in this cohort (n=30), which far exceeded benchmarks for anti-PD-1 (pembrolizumab) monotherapy (61% and 38%) and the standard-of-care anti-PD-1 plus anti-CTLA-4 (ipilimumab and nivolumab) combination (65% and 50%) in this setting (Figure 1). These landmark values also compare favorably with benchmarks for approved anti-PD-1 plus TKI regimens. A 50% confirmed objective response rate (cORR) and 6.7% (n=2) rate of primary progression (progression at or before first scan) were observed, indicating early tumor control. These data compare favorably with benchmarks for pembrolizumab (36% cORR and 30% primary progression) and the ipilimumab and nivolumab combination (39% cORR and 20% primary progression) in this setting. No unexpected safety signals were observed at the time of DCO (n=30). The regimen has shown safety data that are consistent with those observed in other cohorts or prior studies of each molecule. Casdatifan plus ipilimumab plus zimberelimab ( 3 months of median follow-up) Only one patient experienced primary progression (4%, n=24 with at least one scan). No unexpected safety signals were observed at the time of DCO (n=31). Safety data from this cohort are expected to support initiation of PEAK-20, the planned 1L registrational trial evaluating casdatifan plus ipilimumab plus nivolumab, expected to start in the fourth quarter of 2026. Second-line casdatifan plus cabozantinib combination (21.3 months of median follow-up): A 14.5-month median PFS (mPFS) was reached in patients (n=43) treated with casdatifan plus cabozantinib, far exceeding benchmarks for cabozantinib in this setting (~10 months mPFS). The 18-month landmark OS was 77% for the combination (compared to ~60% for cabozantinib benchmarks in this setting [Figure 2]), cORR was 44% and primary progression was 5%. Casdatifan plus cabozantinib demonstrated impressive efficacy, including in patients who had progressed on a prior TKI therapy. TKI-pretreated patients represent approximately 60% of 2L patients in current practice and derive diminished benefit from subsequent TKI therapies. The efficacy of casdatifan plus cabozantinib was similar to that of patients who had not received a TKI in their prior treatment. No unexpected safety signals were observed at the time of DCO (n=44). The regimen has shown safety data that are consistent with those observed in other cohorts or prior studies of each molecule. Arcus is evaluating casdatifan plus cabozantinib, the most prescribed TKI, for the 2L treatment of ccRCC in the ongoing registrational Phase 3 PEAK-1 study. Late-line casdatifan monotherapy (28 months of median follow-up): A 35-month median OS (mOS), 13-month mPFS and 36% cORR were observed in the four pooled monotherapy cohorts (n=121), which evaluated casdatifan in heavily pre-treated patients with metastatic ccRCC (52% had received at least three prior lines of therapy), including both an anti-PD-1 and a VEGFR TKI. The four pooled monotherapy cohorts included: 50mg once daily (QD), 50mg twice daily (BID), 100mg QD (tablet) and 150mg QD. Casdatifan demonstrated improvements across each of the key efficacy measures relative to data from benchmark studies with a first-generation HIF-2α inhibitor (Figure 3). PFS data were similar whether patients had received one, two or three prior TKI-inclusive treatments, in contrast to what has been reported for the only approved HIF-2α inhibitor, which showed an inverse correlation between efficacy and more prior TKI-inclusive therapies in a similar patient population (LITESPARK-013). No unexpected safety signals were observed, and casdatifan showed acceptable and manageable adverse events across all doses. Arcus plans to initiate a registrational trial evaluating casdatifan plus tivozanib compared to tivozanib. Arcus is hosting an in-person and virtual investor event in New York today, beginning at 5:30 AM PT / 8:30 AM ET, to review the new casdatifan data. Investors may register and log in to the live webcast using the following link: . To access a replay of the event and accompanying slide presentation, please visit the “Investors & Media” section of the Arcus Biosciences website at . About Casdatifan (AB521) Casdatifan is a small-molecule inhibitor of hypoxia-inducible factor 2-alpha (HIF-2α), a master switch that turns on hundreds of genes in response to low oxygen levels. In a majority of people with the most common form of kidney cancer (clear cell renal cell carcinoma), genetic anomalies result in the dysregulation of this master switch and transformation of normal kidney cells into cancerous ones. Casdatifan was designed to provide deep and durable inhibition of the HIF-2α pathway. Early clinical studies have shown high response rates and a low primary progression rate relative to clinical benchmarks, warranting further investigation in late-stage studies. Casdatifan, which is administered in pill form once daily, has shown safety data that allow it to be investigated in combination with other treatments. The casdatifan development strategy is designed to generate evidence needed to establish casdatifan as a backbone therapy so that every ccRCC patient has the opportunity to benefit from casdatifan across each line of therapy. In addition to partner-operationalized studies, including combinations with casdatifan and anti-PD-X/VEGF bispecifics, Arcus is investigating casdatifan across multiple cohorts in the ARC-20 platform study, alone and in combination with other potential new treatment options, including in: The first-line setting with cohorts evaluating casdatifan plus zimberelimab, an anti-PD-1 (ongoing); casdatifan plus zimberelimab and ipilimumab, an anti-CTLA-4 (ongoing); and casdatifan plus ivonescimab, an anti-PD-1/VEGF bispecific (ongoing) The second-line setting with a cohort evaluating casdatifan plus cabozantinib, a TKI, in immunotherapy-experienced patients (ongoing) The late-line setting with a cohort evaluating casdatifan plus tivozanib, a TKI, in HIF-2α inhibitor-experienced patients (planned) Arcus is also enrolling PEAK-1, the global Phase 3 study evaluating casdatifan plus cabozantinib versus cabozantinib in immunotherapy-experienced patients with metastatic ccRCC. Casdatifan is an investigational molecule. Approval from any regulatory authority for its use has not been received, and its safety and efficacy have not been established. Taiho has development and commercial rights in Japan and other countries in Asia, excluding China. Arcus Biosciences holds full rights to casdatifan everywhere else globally. About RCC According to the American Cancer Society, kidney cancer is among the top 10 most commonly diagnosed forms of cancer among both men and women in the U.S., and an estimated 80,450 Americans will be diagnosed with kidney cancer in 2026. Clear cell RCC is the most common type of kidney cancer in adults. If detected in its early stages, the five-year survival rate for kidney cancer is high; for patients with advanced or late-stage metastatic kidney cancer, however, the five-year survival rate is only 19%. For metastatic kidney cancer, targeted drug therapies are one of the main treatment options. About Arcus Biosciences Arcus Biosciences is a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for the treatment of cancer and immune diseases. Founded in 2015, Arcus pairs proven biology with exceptional chemistry to create medicines that deliver meaningful improvements for patients. The company has advanced two oncology programs to Phase 3 clinical trials, including casdatifan, a HIF-2α inhibitor for clear cell renal cell carcinoma, and quemliclustat, a small-molecule CD73 inhibitor for pancreatic cancer. Arcus is also applying its small-molecule, medicinal chemistry and antibody capabilities to expand into immunology. Every program is held to the highest standard: outperform the current standard of care. For more information about Arcus Biosciences’ clinical and preclinical programs, please visit . Important Information Regarding Data Comparisons *Note: All referenced benchmarks are based on third-party data and do not represent head-to-head comparisons between casdatifan and any other products or candidates. Differences exist between study populations, sample sizes, inclusion and exclusion criteria, trial designs and many other factors, and caution should be exercised when comparing data across unrelated studies. Important Information Regarding Forward-Looking Statements This press release contains forward-looking statements. All statements regarding events or results to occur in the future contained herein are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, the timing and achievement of milestones, the initiation and completion of clinical trials, and the potential for casdatifan to become a backbone therapy for ccRCC patients. All forward-looking statements involve known and unknown risks and uncertainties and other important factors that may cause Arcus’s actual results, performance or achievements to differ materially from those expressed or implied by the forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, risks associated with: data not being a guarantee of future data and may not be replicated in other studies evaluating casdatifan, including the Phase 3 PEAK-1 study and the upcoming Phase 3 PEAK-20 and PEAK-30 studies; Arcus’s ability to manage the breadth and pace of its development plans for casdatifan; the unexpected emergence of adverse events or other undesirable side effects with casdatifan, alone or in combination with other agents; difficulties or delays in initiating, enrolling and completing clinical trials, including due to regulatory review, site activation, patient identification or enrollment, or manufacturing and supply constraints of investigational or standard-of-care products for such clinical trials; changes in the competitive landscape for Arcus’s programs; and the inherent uncertainty associated with pharmaceutical product development and clinical trials. Risks and uncertainties facing Arcus are described more fully in the “Risk Factors” section of Arcus’s most recent periodic report filed with the U.S. Securities and Exchange Commission (SEC) and in other filings that Arcus makes with the SEC from time to time, which are available at . You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Arcus disclaims any obligation or undertaking to update, supplement or revise any forward-looking statements contained in this press release, except to the extent required by law. The Arcus name and logo are trademarks of Arcus Biosciences, Inc. All other trademarks belong to their respective owners. Contacts Investor Inquiries: Pia Eaves VP of Investor Relations & Strategy (617) 459-2006 peaves@arcusbio.com Media Inquiries: Holli Kolkey VP of Corporate Affairs (650) 922-1269 hkolkey@arcusbio.com Maryam Bassiri Director of Corporate Affairs (510) 406-8520 mbassiri@arcusbio.com

Phase 3Clinical ResultImmunotherapy

19 Oct 2026

·www.biospace.com

BioNTech to Showcase Oncology Late-Stage Pipeline Progress and Pumitamig Novel-Novel Combination Data at ESMO 2026

Late-breaking oral presentation will feature first data from the global ROSETTA Lung-107 Phase 2 clinical trial evaluating pumitamig, a PD-L1×VEGF-A bispecific immunomodulator , plus docetaxel in patients with metastatic non-small cell lung cancer following prior immunotherapy plus chemotherapy Global Phase 2 data for pumitamig plus elfetabart drozuntecan, a B7-H3-targeting antibody-drug conjugate, expand the body of evidence for this novel-novel combination in multiple advanced solid tumors Updates from across the pumitamig clinical development program underscore its pan-tumor potential, including in lung and breast cancer patients with brain metastases and patients with neuroendocrine neoplasms MAINZ, Germany, October 19, 2026 – BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) will present new clinical data from its late-stage oncology pipeline with 16 abstracts spanning the Company’s tumor focus areas, including lung and breast cancer, at the European Society for Medical Oncology (“ESMO”) 2026 Congress held in Madrid, Spain, from October 23–27, 2026. Key oral presentations will focus on clinical data for pumitamig (BNT327/BMS986545), a PD-L1×VEGF-A bispecific immunomodulator being jointly developed with Bristol Myers Squibb (“BMS”), plus docetaxel in second-line metastatic non-small cell lung cancer (“NSCLC”) as well as pumitamig in combination with elfetabart drozuntecan (elfe-D or BNT324/DB-1311), a B7-H3-targeting antibody-drug conjugate (“ADC”) being jointly developed with Duality Biologics (Suzhou) Co. Ltd. (“DualityBio”), across several advanced solid tumors – complementing the data in lung cancer presented earlier this year. This new clinical data advances BioNTech’s differentiated novel-novel combination approach. Additional presentations for pumitamig and ADCs reflect BioNTech’s tumor-focused strategy aimed at addressing significant unmet medical needs across various stages of disease. “Sixteen abstracts spanning ten tumor types – this is our significant data presence at this year’s ESMO. It demonstrates momentum for our late-stage oncology pipeline across strategic key assets and tumor areas such as lung and breast cancer,” said Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech . “For our PD-L1xVEGF immunomodulator pumitamig, we will be sharing new data that highlights its pan-tumor potential, including in challenging treatment settings where patients still show limited benefit from current standard of care therapies. Our goal is to establish pumitamig as a potential backbone for future combination regimens across multiple tumor types, including novel-novel treatment combinations. At this year's conference, we will showcase the potential of this approach in two presentations featuring ADC combinations, aimed to further enhance outcomes for patients.” Highlights from BioNTech’s presentations at ESMO 2026: Pumitamig – an investigational PD-L1×VEGF-A bispecific immunomodulator: NSCLC: First data from the global ROSETTA Lung-107 Phase 2 clinical trial ( NCT06841055 ) evaluating pumitamig plus docetaxel in patients with metastatic NSCLC whose disease progressed after immunotherapy plus chemotherapy will be presented in a late-breaking oral presentation. This clinical trial extends evidence for pumitamig’s non-small cell lung cancer development program into the second-line setting where there remains high unmet medical need, representing the third global Phase 2 dataset in lung cancer. SCLC and TNBC with brain metastases: Results from a subgroup analysis of two Phase 2 clinical trials ( NCT06449209 ; NCT06449222 ) evaluating pumitamig plus chemotherapy in patients with small cell lung cancer (“SCLC”) or triple-negative breast cancer (“TNBC”) showed systemic efficacy generally consistent in patients with and without brain metastases. These early data suggest intracranial efficacy and add to the clinical evidence for pumitamig plus chemotherapy in tumor types where brain metastases often occur and remain challenging to treat as many systemic therapies have limited ability to cross the blood-brain barrier. 2L neuroendocrine neoplasms: First results from a Phase 2 clinical trial conducted in China ( NCT05879055 ) evaluating pumitamig plus FOLFIRI (folinic acid, fluorouracil, and irinotecan) chemotherapy in patients with unresectable neuroendocrine neoplasms after first-line platinum-based chemotherapy showed encouraging preliminary antitumor activity and a manageable safety profile. These data broaden the clinical evidence for pumitamig across diverse tumor types. Novel-novel combination of pumitamig and elfetabart drozuntecan, an investigational B7-H3-targeted ADC: Advanced solid tumors: First results from the global Phase 2 clinical trial ( NCT06953089 ) evaluating pumitamig in combination with elfetabart drozuntecan in patients with advanced solid tumors showed encouraging preliminary antitumor activity across multiple tumor types and a manageable safety profile, with minimal overlapping toxicities observed. These data support the potential of pumitamig as a backbone in novel treatment combinations, furthering BioNTech’s combination strategy across multiple tumor types with high unmet medical need. BioNTech is advancing a diversified oncology pipeline spanning next-generation immunomodulators, ADCs, and mRNA cancer immunotherapies, both as monotherapies and novel-novel combination approaches. With 13 ongoing Phase 3 trials as well as multiple novel-novel combination trials, BioNTech is focused on developing innovative approaches to address the challenges of cancer treatment among the Company’s tumor focus areas from early- to late-stage conditions. All abstracts are available through the ESMO website . Further information on BioNTech’s oncology pipeline can be accessed here . Full presentation details: Candidate Abstract Title Abstract Number/Presentation Details Pumitamig A global phase 2, open-label trial of pumitamig (PD-L1 × VEGF-A bsAb) + docetaxel post-chemoimmunotherapy in mNSCLC: First data from ROSETTA Lung-107 Abstract #LBA76 Rapid Oral Presentation NSCLC, Metastatic Oct 25, 2026: 8:30 - 10:00am CET Efficacy of pumitamig (PD-L1 × VEGF-A bsAb) plus chemotherapy in patients with SCLC or TNBC with brain metastases: A subgroup analysis of two phase 2 trials Abstract #1951RO Rapid Oral Presentation Investigational Immunotherapy Oct 24, 2026: 8:30 - 10:00am CEST First results from a phase 2 trial of second-line pumitamig (PD-L1 × VEGF-A bsAb) plus chemotherapy in unresectable neuroendocrine neoplasms Abstract #2393O Proffered Paper Presentation NETs and Endocrine Tumours Oct 26, 2026: 10:15 - 11:45am CET ROSETTA RCC-208: A phase 1/2, open-label, randomized study of pumitamig alone or in combination with ipilimumab or cabozantinib in advanced renal cell carcinoma (RCC) Abstract #3639TiP Poster Presentation Renal Cancer Oct 23, 2026: 3:15 - 4:00pm CEST ROSETTA Gastric-204: A randomized, phase 2/3 study of first-line (1L) pumitamig + chemotherapy versus nivolumab (NIVO) + chemotherapy in advanced or metastatic gastric cancer (GC), gastroesophageal junction adenocarcinoma (GEJC), or esophageal adenocarcinoma (EAC) Abstract #3081eTiP ePoster Presentation Oesophagogastric Cancer Oct 23 - 27, 2026 A phase 1/2 trial of first-line pumitamig monotherapy or pumitamig plus ipilimumab in advanced or unresectable hepatocellular carcinoma (ROSETTA HCC-206) Abstract #1762eTiP ePoster Presentation Hepatocellular Carcinoma Oct 23 - 27, 2026 Pumitamig + elfetabart drozuntecan Elfetabart drozuntecan (Elfe-D; DB-1311/BNT324 [B7H3 ADC]) + pumitamig (PD-L1 x VEGF-A bsAb) in patients with advanced solid tumors: First results from a global phase 2 trial Abstract #999O Proffered Paper Presentation Developmental Therapeutics Oct 24, 2026: 2:45 - 4:15pm CEST Pumitamig + trastuzumab pamirtecan Pumitamig + trastuzumab pamirtecan (T-Pam) in patients (pts) with HR+, HER2-low advanced/metastatic breast cancer (a/mBC): Phase 1 results of a phase 1/2, open-label trial (BNT323-03) Abstract #1777P Poster Presentation HER2+ Breast Cancer Oct 24, 2026: 12:00 - 12:45pm CEST Elfetabart drozuntecan Elfetabart drozuntecan (Elfe-D; DB-1311/BNT324 [B7H3 ADC]) in patients with platinum-resistant ovarian cancer (PROC): Efficacy and safety data from a Phase 2 dose optimization cohort Abstract #1255P Poster Presentation Gynaecological Cancers Oct 26, 2026: 12:00 - 12:45pm CET BNT324-03: A phase 3, randomized, open-label trial comparing elfetabart drozuntecan, a B7H3 antibody-drug conjugate (ADC), with docetaxel as treatment of patients (pts) with taxane-naïve metastatic castration-resistant prostate cancer (mCRPC) Abstract #2300TiP Poster Presentation Metastatic Prostate Cancer Oct 23, 2026: 3:15 - 4:00pm CEST Gotistobart Gotistobart plus pembrolizumab demonstrates durable antitumor activity in advanced melanoma refractory or resistant to both prior anti-CTLA-4 and anti-PD-(L)1 therapies Abstract #2106P Poster Presentation Melanoma Oct 24, 2026: 12:00 - 12:45 pm CEST BNT317 BNT317: An anti–PD-1 × CD39 bispecific antibody demonstrating preclinical antitumor activity Abstract #420P Poster Presentation Basic Science Oct 23, 2026: 3:15 - 4pm CEST Beruzatatug pelitecan (YL202/BNT326) Clinical outcomes of YL202/BNT326 (HER3 ADC) in advanced/metastatic HR+/HER2-null/low breast cancer (BC) in chemotherapy (chemo)-naïve and exposed patients (pts) Abstract #1881P Poster Presentation HR+ Breast Cancer Oct 24, 2026: 12:00 - 12:45pm CEST BNT329 A first-in-human phase 1/2 dose-escalation and expansion trial of BNT329 (an anti-carbohydrate antigen 19-9 antibody-drug conjugate [CA19-9 ADC]) in patients (pts) with advanced solid tumors that express CA19-9 Abstract #1076TiP Poster Presentation Developmental Therapeutics Oct 23, 2026: 3:15 - 4:00 pm CEST Health Economics and Outcomes Research (HEOR) Real-world progression-free survival (rwPFS) from chemotherapy initiation in patients with HR+/HER2– metastatic breast cancer (mBC) in the US Abstract #1880P Poster Presentation HR+ Breast Cancer Oct 24, 2026: 12:00 - 12:45pm CEST Real-world outcomes with first-line pembrolizumab-based chemoimmunotherapy in patients with advanced/metastatic non-small cell lung cancer in the USA Abstract #2705P Poster Presentation NSCLC, Metastatic Oct 26, 2026: 12:00 - 12:45pm CET About BioNTech BioNTech is a global next generation biopharmaceutical company pioneering novel investigative therapies for cancer and other serious diseases. In oncology, BioNTech is committed to transforming how cancer is treated. Its ambition is to develop innovative medicines with pan-tumor or synergistic potential to address cancer from multiple angles and across the full continuum of the disease from early- to late-stage. Its growing late-stage oncology pipeline comprises complementary treatment approaches spanning immunomodulators, antibody drug conjugates, and mRNA cancer immunotherapies. BioNTech has partnered with multiple global and specialized pharmaceutical collaborators leveraging complementary expertise and resources to accelerate innovation and drive progress, including Bristol Myers Squibb, Duality Biologics, Genentech, a member of the Roche Group, Genmab, MediLink, OncoC4, and Pfizer. For more information, please visit . BioNTech Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: the initiation, timing, progress and results of BioNTech’s research and development programs in oncology, including the targeted timing and number of additional potentially registrational trials; BioNTech’s and its collaborators’ current and future preclinical and clinical trials in oncology, including the investigational bispecific immunomodulator pumitamig (BNT327/BMS986545), the investigational anti-CTLA-4 antibody gotistobart (BNT316/ONC-392), the investigational B7H3-targeting ADC elfetabart drozuntecan (BNT324/DB-1311) alone and in combination with pumitamig, the investigational HER2-targeting ADC trastuzumab pamirtecan (BNT323/DB-1303) in combination with pumitamig, the investigational anti-PD-1×CD39 antibody BNT317, the investigational HER3-targeting ADC Beruzatatug pelitecan (Beru-Pel/YL202/BNT326), and the investigational CA19-9-targeting ADC BNT329; the nature and characterization of and timing for release of clinical data across BioNTech’s platforms, which is subject to peer review, regulatory review and market interpretation; the planned next steps in BioNTech’s pipeline programs, including, but not limited to, statements regarding timing or plans for initiation or enrollment of clinical trials, or submission for and receipt of product approvals and potential commercialization with respect to BioNTech’s product candidates; and the potential safety and efficacy of BioNTech’s product candidates. In some cases, forward-looking statements can be identified by terminology such as “will,” “may,” “should,” “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this press release are based on BioNTech’s current expectations and beliefs of future events and are neither promises nor guarantees. You should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond BioNTech’s control, and which could cause actual results to differ materially and adversely from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to: the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, projected data release timelines, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preclinical and clinical data, including the data discussed in this release, and including the possibility of unfavorable new preclinical, clinical or safety data and further analyses of existing preclinical, clinical or safety data; the nature of the clinical data, which is subject to ongoing peer review, regulatory review and market interpretation; the ability to produce comparable clinical results in future clinical trials; the timing of and BioNTech’s ability to obtain and maintain regulatory approval for its product candidates; discussions with regulatory agencies regarding timing and requirements for additional clinical trials; the impact of tariffs and escalations in trade policy; BioNTech’s ability to identify research opportunities and discover and develop investigational medicines; the ability and willingness of BioNTech’s third-party collaborators to continue research and development activities relating to BioNTech’s development candidates and investigational medicines; unforeseen safety issues and potential claims that are alleged to arise from the use of products and product candidates developed or manufactured by BioNTech; BioNTech’s and its collaborators’ ability to commercialize and market its product candidates, if approved; BioNTech’s ability to manage its development and related expenses; regulatory and political developments; BioNTech’s ability to effectively scale its production capabilities and manufacture its products and product candidates; risks relating to the global financial system and markets; and other factors not known to BioNTech at this time. You should review the risks and uncertainties described under the heading “Risk Factors” in BioNTech’s Report on Form 6-K for the period ended June 30, 2026 and in subsequent filings made by BioNTech with the SEC, which are available on the SEC’s website at . These forward-looking statements speak only as of the date hereof. Except as required by law, BioNTech disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. CONTACTS Media Relations Jasmina Alatovic Media@BioNTech.de Investor Relations Douglas Maffei, Ph.D. Investors@BioNTech.de

Clinical ResultPhase 2ImmunotherapyASCOADC

19 Oct 2026

·www.biospace.com

Bristol Myers Squibb to Showcase Next-Generation Cancer Modalities and Leadership Across Solid Tumors at ESMO 2026

Late-breaking Phase 3 disclosures for izalontamab brengitecan (iza-bren), a potential first-in-class EGFR × HER3 bispecific ADC, in EGFR-mutated non-small cell lung cancer (PANKU-Lung01) and HR+/HER2- breast cancer (PANKU-Breast01) Late-breaking Phase 2 global data presentation for pumitamig, a PD-L1 × VEGF-A bispecific immunomodulator, from ROSETTA Lung-107 in metastatic non-small cell lung cancer PRINCETON, N.J.--(BUSINESS WIRE)-- $BMY #ESMO -- Bristol Myers Squibb (NYSE: BMY) today announced it will present new data from its oncology portfolio and pipeline across a broad range of solid tumors at the European Society for Medical Oncology (ESMO) 2026 Congress to be held October 23-27 in Madrid, Spain. Across 12 oral presentations and nearly 60 disclosures, the company will highlight progress across differentiated therapeutic approaches, including: Late-breaking global Phase 2 data for pumitamig, an investigational PD-L1 x VEGF-A bispecific immunomodulator, being jointly developed with BioNTech Two late-breaking, Phase 3 studies of izalontamab brengitecan (iza-bren), a potential first-in-class EGFR x HER3 bispecific antibody drug conjugate (ADC), sponsored by SystImmune’s parent company, Sichuan Biokin Pharmaceutical Co., Ltd. (Biokin) Long-term survival results evaluating Opdivo ® in combination with Yervoy ® in a Phase 3 late-breaking oral presentation “BMS is advancing a new generation of oncology medicines designed to address some of the most persistent challenges faced by patients with cancer,” said Cristian Massacesi, MD , executive vice president, chief medical officer and head of Development, Bristol Myers Squibb. “At ESMO 2026, we will share important data across both emerging and established modalities. From new Phase 3 results for iza-bren and new findings for pumitamig, to long-term survival data for Opdivo ® plus Yervoy ® , these results reflect the breadth of our oncology pipeline, and our focus on translating differentiated science into meaningful, durable outcomes for patients.” Key data highlights across diverse modalities and scientific approaches to be presented at the ESMO 2026 Congress: Abstract Title Author Presentation Type/# Session Title Session Date/Time (Local Time (Madrid) Thoracic Cancer A Global Phase 2, Open-label Trial of Pumitamig (PD-L1 × VEGF-A bsAb) + Docetaxel Post-chemoimmunotherapy in mNSCLC: First Data from ROSETTA Lung-107 Cho Rapid Oral #LBA76 Rapid Oral 2: NSCLC, Metastatic Sunday, October 25, 8:30 – 10:00 AM PANKU-Lung01: Randomized Phase 3 Study of Izalontamab Brengitecan (iza-bren) in EGFR-Mutant Non-Squamous Non-Small Cell Lung Cancer (NSCLC) After Progression on a Third Generation EGFR TKI Zhang Proffered Paper #LBA71 Proffered Paper 2: NSCLC, Metastatic Monday, October 26, 8:30 – 10:00 AM Phase 2 Study of Izalontamab Brengitecan (iza-bren) Plus Osimertinib in Patients with EGFR Mutant Locally Advanced or Metastatic NSCLC Zhou Poster #2575P Poster Display Session Monday, October 26, 12:00 – 12:45 PM Breast/Thoracic Cancer Efficacy of Pumitamig (PD-L1 × VEGF-A bsAb) Plus Chemotherapy in Patients with SCLC and TNBC with Brain Metastases: Subgroup Analyses of Two Phase 2 Trials Pavlakis Rapid Oral #1951RO Rapid Oral: Investigational Immunotherapy Saturday, October 24, 8:30 – 10:00 AM Breast Cancer PANKU-Breast01: Randomized Phase 3 Study of Izalontamab Brengitecan (iza-bren) in Previously Treated Unresectable Locally Advanced or Metastatic (LA/M) Hormone Receptor-Positive/HER2- negative (HR+/HER2-) Breast Cancer (BC) Lan Proffered Paper #LBA50 Proffered Paper 1: Breast Cancer, Early and Advanced Stage Friday October 23, 1:30 – 3:00 PM Head and Neck Cancer Phase 2 Study of Izalontamab Brengitecan (iza-bren) Plus Pembrolizumab in Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma Ji Rapid Oral #1542RO Rapid Oral: Head and Neck Cancer Sunday, October 25, 2:45 – 4:15 PM Gastrointestinal Cancer Prevalence, Prognosis, and Impact on Tumor Microenvironment of Homozygous MTAP Deletion in Advanced Solid Tumors Rodón Poster #4445P Poster Display Session Friday, October 23, 3:15 – 4:00 PM Final Overall Survival Results from CheckMate 8HW: Nivolumab plus Ipilimumab vs Nivolumab or Chemotherapy in MSI-H/dMMR Metastatic Colorectal Cancer Lonardi Rapid Oral #LBA32 Rapid Oral: Gastrointestinal Tumours, Lower Digestive Saturday, October 24, 2:45 – 4:15 PM Genitourinary Cancer Results From a Phase 3 Trial of Neoadjuvant Chemotherapy Alone vs in Combination with Nivolumab Followed by Postsurgical Adjuvant Nivolumab in Patients with Muscle-Invasive Bladder Cancer Necchi Proffered Paper #4736O Proffered Paper 1: Genitourinary Tumour, Renal and Urothelial Friday, October 23, 1:30 – 3:00 PM Pan Tumor Cancer First Results from a Phase 2 Trial of Second-Line Pumitamig (PD-L1 × VEGF-A bsAb) Plus Chemotherapy in Unresectable Neuroendocrine Neoplasms Xu Proffered Paper #2393O Proffered Paper: NETs and Endocrine Tumours Monday, October 26, 10:15 – 11:45 AM When Overall Survival Is Not Enough: The Emerging Need for Context-Sensitive Endpoint Frameworks in Oncology Cardone Proffered Paper #3315O Proffered Paper: Policy Sunday, October 25, 10:15 – 11:45 AM INDICATIONS OPDIVO ® (nivolumab), as a single agent, is indicated for the treatment of adult and pediatric patients 12 years and older with unresectable or metastatic melanoma. OPDIVO ® (nivolumab), in combination with YERVOY ® (ipilimumab), is indicated for the treatment of adult and pediatric patients 12 years and older with unresectable or metastatic melanoma. OPDIVO ® (nivolumab) is indicated for the adjuvant treatment of adult and pediatric patients 12 years and older with completely resected Stage IIB, Stage IIC, Stage III, or Stage IV melanoma. OPDIVO ® (nivolumab), in combination with platinum-doublet chemotherapy, is indicated as neoadjuvant treatment of adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (NSCLC). OPDIVO ® (nivolumab) in combination with platinum-doublet chemotherapy, is indicated for neoadjuvant treatment of adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements, followed by single-agent OPDIVO ® as adjuvant treatment after surgery. OPDIVO ® (nivolumab), in combination with YERVOY ® (ipilimumab), is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (≥1%) as determined by an FDA-authorized test, with no EGFR or ALK genomic tumor aberrations. OPDIVO ® (nivolumab), in combination with YERVOY® (ipilimumab) and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations. OPDIVO ® (nivolumab) is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO. OPDIVO ® (nivolumab), in combination with YERVOY ® (ipilimumab), is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma (MPM). OPDIVO ® (nivolumab), in combination with YERVOY ® (ipilimumab), is indicated for the first-line treatment of adult patients with intermediate or poor risk advanced renal cell carcinoma (RCC). OPDIVO ® (nivolumab), in combination with cabozantinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC). OPDIVO ® (nivolumab) is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy. OPDIVO ® (nivolumab), as a single agent, is indicated for the treatment of adult patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin or after 3 or more lines of systemic therapy that includes autologous HSCT. OPDIVO ® (nivolumab), in combination with doxorubicin, vinblastine, and dacarbazine (AVD), is indicated for the treatment of adult and pediatric patients 12 years and older with previously untreated, Stage III or IV classical Hodgkin lymphoma (cHL). OPDIVO ® (nivolumab) is indicated for the treatment of adult patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy. OPDIVO ® (nivolumab), as a single agent, is indicated for the adjuvant treatment of adult patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection of UC. OPDIVO ® (nivolumab), in combination with cisplatin and gemcitabine, is indicated for the first-line treatment for adult patients with unresectable or metastatic urothelial carcinoma. OPDIVO ® (nivolumab) is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. OPDIVO ® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adult and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) unresectable or metastatic colorectal cancer (CRC) as determined by an FDA-authorized test. OPDIVO ® (nivolumab), as a single agent, is indicated for the treatment of adult and pediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. OPDIVO ® (nivolumab), in combination with YERVOY ® (ipilimumab), is indicated for the first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC). OPDIVO ® (nivolumab), in combination with YERVOY ® (ipilimumab), is indicated for the treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. OPDIVO ® (nivolumab) is indicated for the adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in adult patients who have received neoadjuvant chemoradiotherapy (CRT). OPDIVO ® (nivolumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (≥1). OPDIVO ® (nivolumab), in combination with YERVOY ® (ipilimumab), is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (≥1). OPDIVO ® (nivolumab) is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy. OPDIVO ® (nivolumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the treatment of adult patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma whose tumors express PD-L1 (≥1). IMPORTANT SAFETY INFORMATION Severe and Fatal Immune-Mediated Adverse Reactions Immune-mediated adverse reactions listed herein may not include all possible severe and fatal immune-mediated adverse reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. While immune-mediated adverse reactions usually manifest during treatment, they can also occur after discontinuation of OPDIVO or YERVOY. Early identification and management are essential to ensure safe use of OPDIVO and YERVOY. Monitor for signs and symptoms that may be clinical manifestations of underlying immune-mediated adverse reactions. Evaluate clinical chemistries including liver enzymes, creatinine, adrenocorticotropic hormone (ACTH) level, and thyroid function at baseline and periodically during treatment with OPDIVO and before each dose of YERVOY. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate. Withhold or permanently discontinue OPDIVO and YERVOY depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information). In general, if OPDIVO or YERVOY interruption or discontinuation is required, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy. Toxicity management guidelines for adverse reactions that do not necessarily require systemic steroids (e.g., endocrinopathies and dermatologic reactions) are discussed below. Immune-Mediated Pneumonitis OPDIVO and YERVOY can cause immune-mediated pneumonitis. The incidence of pneumonitis is higher in patients who have received prior thoracic radiation. In patients receiving OPDIVO monotherapy, immune-mediated pneumonitis occurred in 3.1% (61/1994) of patients, including Grade 4 (<0.1%), Grade 3 (0.9%), and Grade 2 (2.1%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, immune-mediated pneumonitis occurred in 7% (31/456) of patients, including Grade 4 (0.2%), Grade 3 (2.0%), and Grade 2 (4.4%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune-mediated pneumonitis occurred in 3.9% (26/666) of patients, including Grade 3 (1.4%) and Grade 2 (2.6%). In NSCLC patients receiving OPDIVO 3 mg/kg every 2 weeks with YERVOY 1 mg/kg every 6 weeks, immune-mediated pneumonitis occurred in 9% (50/576) of patients, including Grade 4 (0.5%), Grade 3 (3.5%), and Grade 2 (4.0%). Four patients (0.7%) died due to pneumonitis. Immune-Mediated Colitis OPDIVO and YERVOY can cause immune-mediated colitis, which may be fatal. A common symptom included in the definition of colitis was diarrhea. Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. In patients receiving OPDIVO monotherapy, immune-mediated colitis occurred in 2.9% (58/1994) of patients, including Grade 3 (1.7%) and Grade 2 (1%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, immune-mediated colitis occurred in 25% (115/456) of patients, including Grade 4 (0.4%), Grade 3 (14%) and Grade 2 (8%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune-mediated colitis occurred in 9% (60/666) of patients, including Grade 3 (4.4%) and Grade 2 (3.7%). Immune-Mediated Hepatitis and Hepatotoxicity OPDIVO and YERVOY can cause immune-mediated hepatitis. In patients receiving OPDIVO monotherapy, immune-mediated hepatitis occurred in 1.8% (35/1994) of patients, including Grade 4 (0.2%), Grade 3 (1.3%), and Grade 2 (0.4%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, immune-mediated hepatitis occurred in 15% (70/456) of patients, including Grade 4 (2.4%), Grade 3 (11%), and Grade 2 (1.8%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune-mediated hepatitis occurred in 7% (48/666) of patients, including Grade 4 (1.2%), Grade 3 (4.9%), and Grade 2 (0.4%). OPDIVO in combination with cabozantinib can cause hepatic toxicity with higher frequencies of Grade 3 and 4 ALT and AST elevations compared to OPDIVO alone. Consider more frequent monitoring of liver enzymes as compared to when the drugs are administered as single agents. In patients receiving OPDIVO and cabozantinib, Grades 3 and 4 increased ALT or AST were seen in 11% (35/320) of patients. Immune-Mediated Endocrinopathies OPDIVO and YERVOY can cause primary or secondary adrenal insufficiency, immune-mediated hypophysitis, immune-mediated thyroid disorders, and Type 1 diabetes mellitus, which can present with diabetic ketoacidosis. Withhold OPDIVO and YERVOY depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information). For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field defects. Hypophysitis can cause hypopituitarism; initiate hormone replacement as clinically indicated. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism; initiate hormone replacement or medical management as clinically indicated. Monitor patients for hyperglycemia or other signs and symptoms of diabetes; initiate treatment with insulin as clinically indicated. In patients receiving OPDIVO monotherapy, adrenal insufficiency occurred in 1% (20/1994), including Grade 3 (0.4%) and Grade 2 (0.6%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, adrenal insufficiency occurred in 8% (35/456) of patients, including Grade 4 (0.2%), Grade 3 (2.4%), and Grade 2 (4.2%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, adrenal insufficiency occurred in 7% (48/666) of patients, including Grade 4 (0.3%), Grade 3 (2.5%), and Grade 2 (4.1%). In patients receiving OPDIVO and cabozantinib, adrenal insufficiency occurred in 4.7% (15/320) of patients, including Grade 3 (2.2%) and Grade 2 (1.9%). In patients receiving OPDIVO monotherapy, hypophysitis occurred in 0.6% (12/1994) of patients, including Grade 3 (0.2%) and Grade 2 (0.3%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, hypophysitis occurred in 9% (42/456) of patients, including Grade 3 (2.4%) and Grade 2 (6%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, hypophysitis occurred in 4.4% (29/666) of patients, including Grade 4 (0.3%), Grade 3 (2.4%), and Grade 2 (0.9%). In patients receiving OPDIVO monotherapy, thyroiditis occurred in 0.6% (12/1994) of patients, including Grade 2 (0.2%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, thyroiditis occurred in 2.7% (22/666) of patients, including Grade 3 (4.5%) and Grade 2 (2.2%). In patients receiving OPDIVO monotherapy, hyperthyroidism occurred in 2.7% (54/1994) of patients, including Grade 3 (<0.1%) and Grade 2 (1.2%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, hyperthyroidism occurred in 9% (42/456) of patients, including Grade 3 (0.9%) and Grade 2 (4.2%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, hyperthyroidism occurred in 12% (80/666) of patients, including Grade 3 (0.6%) and Grade 2 (4.5%). In patients receiving OPDIVO monotherapy, hypothyroidism occurred in 8% (163/1994) of patients, including Grade 3 (0.2%) and Grade 2 (4.8%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, hypothyroidism occurred in 20% (91/456) of patients, including Grade 3 (0.4%) and Grade 2 (11%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, hypothyroidism occurred in 18% (122/666) of patients, including Grade 3 (0.6%) and Grade 2 (11%). In patients receiving OPDIVO monotherapy, diabetes occurred in 0.9% (17/1994) of patients, including Grade 3 (0.4%) and Grade 2 (0.3%), and 2 cases of diabetic ketoacidosis. In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, diabetes occurred in 2.7% (15/666) of patients, including Grade 4 (0.6%), Grade 3 (0.3%), and Grade 2 (0.9%). Immune-Mediated Nephritis with Renal Dysfunction OPDIVO and YERVOY can cause immune-mediated nephritis. In patients receiving OPDIVO monotherapy, immune-mediated nephritis and renal dysfunction occurred in 1.2% (23/1994) of patients, including Grade 4 (<0.1%), Grade 3 (0.5%), and Grade 2 (0.6%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune-mediated nephritis with renal dysfunction occurred in 4.1% (27/666) of patients, including Grade 4 (0.6%), Grade 3 (1.1%), and Grade 2 (2.2%). Immune-Mediated Dermatologic Adverse Reactions OPDIVO and YERVOY can cause immune-mediated rash or dermatitis. Exfoliative dermatitis, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug rash with eosinophilia and systemic symptoms (DRESS) has occurred with PD-1/PD-L1 blocking antibodies. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-exfoliative rashes. Withhold or permanently discontinue OPDIVO and YERVOY depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information). In patients receiving OPDIVO monotherapy, immune-mediated rash occurred in 9% (171/1994) of patients, including Grade 3 (1.1%) and Grade 2 (2.2%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, immune-mediated rash occurred in 28% (127/456) of patients, including Grade 3 (4.8%) and Grade 2 (10%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune-mediated rash occurred in 16% (108/666) of patients, including Grade 3 (3.5%) and Grade 2 (4.2%). Other Immune-Mediated Adverse Reactions The following clinically significant immune-mediated adverse reactions occurred at an incidence of <1% (unless otherwise noted) in patients who received OPDIVO monotherapy or OPDIVO in combination with YERVOY, or were reported with the use of other PD-1/PD-L1 blocking antibodies. Severe or fatal cases have been reported for some of these adverse reactions: cardiac/vascular: myocarditis, pericarditis, vasculitis; nervous system: meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barré syndrome, nerve paresis, autoimmune neuropathy; ocular: uveitis, iritis, and other ocular inflammatory toxicities can occur; gastrointestinal: pancreatitis to include increases in serum amylase and lipase levels, gastritis, duodenitis; musculoskeletal and connective tissue: myositis/polymyositis, rhabdomyolysis, and associated sequelae including renal failure, arthritis, polymyalgia rheumatica; endocrine: hypoparathyroidism; hematologic/immune: hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis (HLH), systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenic purpura, solid organ transplant rejection, other transplant (including corneal graft) rejection; other: Myocarditis-Myositis-Myasthenia Gravis (or Myasthenia-Like) Overlap Syndrome, reporting as the co-occurrence of either two or all three adverse reactions. Contacts Bristol Myers Squibb Media Inquiries: media@bms.com Investors: investor.relations@bms.com Read full story here

Phase 2Phase 3Clinical ResultDrug ApprovalAccelerated Approval

100 Deals associated with Cabozantinib (s)-Malate

External Link

KEGG	Wiki	ATC	Drug Bank
D10095	Cabozantinib (s)-Malate	L01EX07	DB08875

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Neuroendocrine Tumors	United Kingdom	Ipsen SA	26 Sep 2025
Well Differentiated Pancreatic Endocrine Tumor	European Union	Ipsen Pharma SAS	24 Jul 2025
Well Differentiated Pancreatic Endocrine Tumor	Iceland	Ipsen Pharma SAS	24 Jul 2025
Well Differentiated Pancreatic Endocrine Tumor	Liechtenstein	Ipsen Pharma SAS	24 Jul 2025
Well Differentiated Pancreatic Endocrine Tumor	Norway	Ipsen Pharma SAS	24 Jul 2025
Extra-pancreatic neuroendocrine tumor	Australia	Ipsen Pty Ltd.	19 Jan 2018
Neuroendocrine tumor of pancreas	Australia	Ipsen Pty Ltd.	19 Jan 2018
Differentiated Thyroid Gland Carcinoma	South Korea	Ipsen Ltd.	26 Sep 2017
Renal Cell Carcinoma	South Korea	Ipsen Ltd.	26 Sep 2017
Hepatocellular Carcinoma	European Union	Ipsen Pharma SAS	09 Sep 2016
Hepatocellular Carcinoma	Iceland	Ipsen Pharma SAS	09 Sep 2016
Hepatocellular Carcinoma	Liechtenstein	Ipsen Pharma SAS	09 Sep 2016
Hepatocellular Carcinoma	Norway	Ipsen Pharma SAS	09 Sep 2016
Advanced Renal Cell Carcinoma	United States	Exelixis, Inc.	25 Apr 2016
Thyroid Cancer, Medullary	United States	Exelixis, Inc.	29 Nov 2012

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Solid tumor	NDA/BLA	China	Jiangsu Hansoh Pharmaceutical Group Co., Ltd.	28 Sep 2020
Refractory Differentiated Thyroid Gland Carcinoma	Phase 3	United States	ECOG-ACRIN Medical Research Foundation, Inc.	27 Dec 2024
Refractory Thyroid Gland Carcinoma	Phase 3	United States	ECOG-ACRIN Medical Research Foundation, Inc.	27 Dec 2024
Metastatic osteosarcoma	Phase 3	-	Children's Oncology Group	13 Jan 2023
Unresectable Bone Sarcoma	Phase 3	-	Children's Oncology Group	13 Jan 2023
Advanced Urothelial Carcinoma	Phase 3	United States	National Cancer Institute	03 Jun 2022
Advanced Urothelial Carcinoma	Phase 3	Canada	National Cancer Institute	03 Jun 2022
Bladder Cancer	Phase 3	United States	National Cancer Institute	03 Jun 2022
Bladder Cancer	Phase 3	Canada	National Cancer Institute	03 Jun 2022
Metastatic Urethral Urothelial Carcinoma	Phase 3	United States	National Cancer Institute	03 Jun 2022

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05411081 (SWOG S2200, ESMO2026)	Phase 2	Papillary Renal Cell Carcinoma	33	Cabozantinib 60 mg oral daily	czbglcahuq(aekuvzwror): HR = 0.46 (90.0% CI, 0.22 - 0.97), P-Value = 0.043 View more	Positive	23 Oct 2026
				Cabozantinib 60 mg oral daily+ Atezolizumab 1200 mg IV every 3 weeks
ESMO2026	Not Applicable	Advanced Renal Cell Carcinoma First line	208	Cabozantinib combined with nivolumab (cabo/nivo)	iqkkbxscex(cavbhrkkkv) = swpqgyuogo nvzoautqhi (cfytxpwdpk ) View more	Positive	23 Oct 2026
				Cabozantinib combined with nivolumab (cabo/nivo) (Favourable risk)	imwphfdjbp(pkaimywgns) = knhsztbrzc bcxkzsmffh (mwouawfusk )
NCT03937219 (COSMIC-313, ESMO2026)	Phase 3	Advanced Renal Cell Carcinoma First line kidney injury molecule-1 (KIM-1)	855	Nivolumab + Ipilimumab + Placebo	pyxaqgnwvf(zdehymhmml) = wrrxossbqw lmvcvklhdx (kgwemedyrj ) View more	Positive	23 Oct 2026
				Nivolumab + Ipilimumab + Cabozantinib	pyxaqgnwvf(zdehymhmml) = hdlnwkyeug lmvcvklhdx (kgwemedyrj ) View more
ESMO2026	Not Applicable	Advanced Renal Cell Carcinoma	70	Cabozantinib + RT	uyvazollah(cjyourflaz) = vghhrxhdbh nchjiuyptv (tsuaqnepde, 25.2 - 48.9) View more	Positive	23 Oct 2026
				Cabozantinib + RT (IMDC poor-risk)	uyvazollah(cjyourflaz) = htvalwdgvi nchjiuyptv (tsuaqnepde ) View more
NCT01639508 (ESMO2026)	Phase 2	ROS1-fusion-positive	7	Cabozantinib	aforoiseva(itqgbqpwij) = ypexzghfee mhaokkpruj (axxhedxjut, 9.9 - 81.5) View more	Positive	23 Oct 2026
NCT05660954 (GETNE-CABOTHYROID, ESMO2026)	Phase 2	Refractory Thyroid Gland Carcinoma	41	Cabozantinib	ebtpsttubw(dvflvzlbjo) = cewqfzikgu nzmgitzlou (tnmhpveuww, 14.0 - NR) View more	Positive	23 Oct 2026
ESMO2026	Not Applicable	Metastatic Renal Cell Carcinoma	87	Cabozantinib alone	eafsrfvkyd(ipvnrlagdv) = Higher concentrations tended to be associated with ≥ G2 toxicity hnitxhockl (vbdahfanto )	Positive	23 Oct 2026
				Cabozantinib with nivolumab
ESMO2026	Not Applicable	Metastatic Renal Cell Carcinoma Second line VHL \| PBRM1 \| SETD2 ... View more	75	Cabozantinib (long responders (LR))	rppjniqtrg(wxibkwqnmi) = wrawrvsefo nxhlwqzkpo (mdpvuxqgne ) View more	Positive	23 Oct 2026
				Cabozantinib (primary refractory (PR))	xzbxdwwscr(adzzzyxlnp) = ohpbbxvxcv cofcaucaza (bnoeliracs )
ESMO2026	Not Applicable	Metastatic Renal Cell Carcinoma Second line \| Third line	61	cabozantinib (continuous 60 mg starting dose)	vqjzwdiegs(oisdsbmrzs) = mewevcrbyp tkregidxsu (bzcfnumkrj ) View more	Positive	23 Oct 2026
				cabozantinib (continuous 40 mg starting dose)	vqjzwdiegs(oisdsbmrzs) = nfmzqktzlb tkregidxsu (bzcfnumkrj ) View more
NCT05048901 (TCOG 2221, ESMO2026)	Phase 1/2	Gastro-Enteropancreatic Neuroendocrine Tumor	42	Cabozantinib 60 mg daily and Lanreotide 120 mg every 4 weeks	zlvozatkrm(vxgnyhaido) = fvdyaqbznc vtpcsnlfvs (qlrsegougo, 6.7 - 43.7) View more	Positive	23 Oct 2026
				Cabozantinib 60 mg daily and Lanreotide 120 mg every 4 weeks (pancreatic NET (pNET))	zlvozatkrm(vxgnyhaido) = nxyixnjnms vtpcsnlfvs (qlrsegougo, 22.4 - 32.6)

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