Pumitamig

As investors search for clues about whether the PD-(L)1/VEGF bispecific class can live up to the hype that was sparked by Akeso and Summit Therapeutics' ivonescimab two years ago, newly released abstracts ahead of the upcoming American Society of Clinical Oncology (ASCO) meeting shed some light on a pair of fast followers (see – Spotlight On: Lung cancer bispecifics poised to take centre stage at ASCO this year).BioNTech and Bristol Myers Squibb offered the first substantial look at their contender, pumitamig (BNT327), in a setting comparable to ivonescimab's HARMONi-3 and HARMONi-6 studies — the latter a China-only trial due to report overall survival (OS) data at ASCO — while Pfizer released updated data for its own PD-1/VEGF bispecific, PF-08634404.Investors appeared encouraged by the pumitamig data in particular, with BioNTech's stock jumping about 6% in after-hours trading Thursday. On the other hand, shares in Summit, which recently reported some disappointing data from HARMONi-3, slid about 8% (see – KOL Views Preview: What interim PFS miss means for ivonescimab, PD-1/VEGF bispecifics in NSCLC).The pumitamig results are drawn from the Phase II portion of the ROSETTA Lung-02 trial, testing the bispecific plus chemotherapy in previously untreated advanced non–small-cell lung cancer (NSCLC) patients, regardless of PD-L1 status. The study enrolled patients with both squamous and non-squamous tumours.70% response rateAmong 40 evaluable patients, pumitamig plus chemotherapy achieved a 70% objective response rate (ORR), including two complete responses (CR) and 26 partial responses (PR). Disease control reached 100%, while tumour shrinkage appeared broadly similar across squamous (73.7%) and non-squamous disease (66.7%), with activity across PD-L1 levels. The lower 1400-mg dose numerically outperformed the higher-dose arm, with response rates of 81.8% in squamous disease and 72.7% in non-squamous disease.However, the data are still early. The confirmed response rate fell to 52.5% after excluding five pending confirmations, and duration-of-response data weren't mature yet at the November 2025 cutoff. Median treatment duration was 4.5 months and nearly 70% of patients remained on treatment at the time of analysis.Meanwhile, grade 3 or higher treatment-related adverse events (TRAEs) in ROSETTA Lung-02 occurred in 19 patients (44.2%), though only 8 cases (18.6%) were deemed directly related to pumitamig. Two patients (4.7%) discontinued treatment due to pumitamig-related TRAEs. Bleeding events were reported in 7 patients (16.3%), with only one grade 3 event, while severe immune-related toxicities were relatively uncommon.Pfizer's contenderMeanwhile, Pfizer's abstract offered an updated glimpse at a potential PD-(L)1/VEGF challenger. Pfizer acquired rights to PF-08634404, also known as SSGJ-707, from 3SBio last year in a deal worth $1.25 billion upfront (see – Spotlight On: Pfizer calls out differentiating features of newly in-licensed bispecific antibody).Unlike pumitamig, Pfizer's Phase II study evaluated the drug as a monotherapy in previously untreated patients with PD-L1–positive advanced NSCLC.At the FDA-aligned 10 mg/kg dose in 34 evaluable patients, the drug achieved a confirmed ORR of 67.6%, with median progression-free survival reaching 12.4 months for non-squamous patients and 8.9 months for squamous patients after a little over 15 months of follow-up. Median duration of response and OS had not yet been reached.The most common side effects were pneumonia (8.4%), hypertension (7.2%) and haemoptysis (6%), though discontinuation rates remained relatively low. Pfizer recently advanced its drug as a combination with chemotherapy for first-line patients in the Phase III Symbiotic-Lung-01 study.

Pumitamig data from the ongoing Phase 2/3 ROSETTA Lung-02 trial in first-line non-small cell lung cancer mark the third global data set to consistently show encouraging anti-tumor activity for pumitamig in combination with chemotherapy Gotistobart Phase 2 overall survival data in patients with platinum-resistant ovarian cancer add to the growing body of evidence supporting its potential as a chemotherapy-free treatment option Continued advancement of late-stage oncology pipeline with 25+ Phase 2 and Phase 3 clinical trials, including 13 ongoing pivotal trials as well as novel-novel combination trials across major cancer types MAINZ, Germany, May 22, 2026 – BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) will present new clinical data and trial updates from its late-stage oncology pipeline and innovative combination programs at the 2026 American Society of Clinical Oncology (“ASCO”) Annual Meeting held in Chicago, from May 29 to June 02. Two oral presentations will highlight new data for key strategic assets pumitamig and gotistobart. In addition, four trial in progress poster presentations will illustrate advancement of the Company’s ongoing pivotal trials and novel-novel combination trials, including antibody-drug conjugates (“ADC”). “Achieving more for patients with cancer through translating science into innovative therapies is our unwavering ambition at BioNTech,” said Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech . “At this year’s ASCO, our presentations underscore our oncology strategy of building a diversified portfolio of complementary modalities delivering differentiated therapeutic profiles across tumor types with high unmet medical need. We are focused on accelerating key strategic programs, both as monotherapies and combinations with standard of care treatments, to deliver our first wave of oncology innovations to patients. Simultaneously, and building on this momentum, we are advancing novel-novel combination approaches, including ADC-based regimens, to unlock the full synergistic potential of our pipeline.” Highlights of BioNTech’s late-stage oncology programs to be presented at ASCO 2026: Pumitamig (BNT327/BMS986545) – an investigational bispecific immunomodulator combining PD-L1 checkpoint inhibition and VEGF-A neutralization, developed in collaboration with Bristol Myers Squibb Company (“BMS”): 1L NSCLC: Data from the interim analysis of the Phase 2 dose-optimization part of the global Phase 2/3 ROSETTA Lung-02 clinical trial ( NCT06712316 ) showed encouraging anti-tumor activity in first-line (“1L”) non-small cell lung cancer (“NSCLC”). The trial evaluated pumitamig plus chemotherapy in patients with non-squamous and squamous NSCLC without actionable genomic alterations and across PD-L1 expression levels. These data mark the third global data set to consistently show encouraging anti-tumor activity for pumitamig plus chemotherapy, adding to the reported global data in small cell lung cancer and triple-negative breast cancer. The results inform the ongoing pivotal Phase 3 part of ROSETTA Lung-02 evaluating pumitamig plus chemotherapy versus pembrolizumab plus chemotherapy. Updated data from a later cut-off date will be presented in a rapid oral presentation. Gotistobart (BNT316/ONC-392) – an investigational tumor microenvironment-selective regulatory T cell depletion candidate targeting CTLA-4, developed in collaboration with OncoC4, Inc. (“OncoC4”): PROC : Data from the Phase 2 PRESERVE-004 clinical trial ( NCT05446298 ) evaluating gotistobart plus pembrolizumab in heavily pre-treated patients with platinum-resistant ovarian cancer (“PROC”) showed durable anti-tumor activity and clinically meaningful overall survival outcomes. Together with a manageable safety profile, the results add to the growing body of evidence supporting gotistobart’s potential as a chemotherapy-free treatment option, complementing the recently announced data in second and later line squamous non-small cell lung cancer. BioNTech is advancing a diversified oncology pipeline spanning next-generation immunomodulators, ADCs, and mRNA cancer immunotherapies, both as monotherapies and novel treatment combination approaches. With more than 25 Phase 2 and Phase 3 clinical trials, including 13 ongoing pivotal trials as well as 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 on the ASCO website . Further information on BioNTech’s late-stage oncology portfolio can be accessed here . Full presentation details: Medicine Abstract Title Abstract Number/Presentation Details Pumitamig Phase 2 data from ROSETTA Lung-02, a global randomized Phase 2/3 trial of pumitamig (PDL1 × VEGF-A bsAb) + chemotherapy in 1L NSCLC Abstract # 8513 Rapid Oral Abstract Session Lung Cancer - Non-Small Cell Metastatic May 30, 2026, 1:15 - 2:45pm CDT Phase 2/3 trial of pumitamig (PD-L1 ×VEGF-A bsab) plus chemotherapy versus bevacizumab plus chemotherapy in previously untreated, unresectable, or metastatic colorectal cancer (ROSETTA CRC-203) Abstract # TPS3672 Poster Session Genitourinary Cancer - Prostate, Testicular, and Penile Poster Board: 229a May 31, 2026: 9:00am-12:00pm CDT Gotistobart Overall survival for patients with pre-treated platinum-resistant ovarian cancer receiving gotistobart in combination with pembrolizumab Abstract # 5511 Rapid Oral Abstract session Gynecologic Cancer May 30, 2026: 8:00 - 9:30am CDT BNT326/YL202 BNT326-01: A Phase 1b/2 trial of BNT326/YL202 (HER3 ADC) as monotherapy and in combination with pumitamig (anti-PD-L1 × VEGF bsAb) in patients with advanced solid tumors Abstract # TPS3160 Poster Session Developmental Therapeutics -Molecularly Targeted Agents and Tumor Biology Poster Board: 294b May 30, 2026: 1:30 - 4:30pm CDT BNT324/DB-1311 BNT324-03: A Phase 3, randomized, open-label trial of BNT324/DB-1311, a B7H3 ADC, versus docetaxel in patients with taxane-naïve metastatic castration-resistant prostate cancer (mCRPC) Abstract # TPS5137 Poster Session Genitourinary Cancer - Prostate, Testicular, and Penile Poster Board: 229a May 31, 2026: 9:00am - 12:00pm CDT Trastuzumab pamirtecan (BNT323/DB-1303) Fern-EC-01 (BNT323-01): A phase 3 trial of trastuzumab pamirtecan (HER2 ADC) versus investigator’s choice of chemotherapy in patients with previously treated, HER2-expressing, recurrent endometrial cancer (EC) Abstract # TPS5645 Poster Session Gynecologic Cancer Poster Board: 302b June 1, 2026: 9:00am - 12:00pm CDT 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) in multiple indications, the investigational anti-CTLA-4 antibody gotistobart (BNT316/ONC-392) in multiple indications, the investigational B7H3-targeted ADC BNT324/DB-1311 in metastatic castration-resistant prostate cancer, the investigational HER2-targeted ADC trastuzumab pamirtecan (BNT323/DB-1303) in recurrent endometrial cancer, and the investigational HER3-targeted ADC BNT326/YL202 as monotherapy and in combination with pumitamig in NSCLC and advanced solid tumors; 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; the ability of BioNTech’s mRNA technology to demonstrate clinical efficacy outside of BioNTech’s infectious disease platform; and the potential safety and efficacy of BioNTech’s product candidates. 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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 March 31, 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, PhD Investors@biontech.de