On May 22, 2026 BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company") reported it 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) (Free ASCO Whitepaper) ("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").

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"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 (Free ASCO Whitepaper), 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 (Free ASCO Whitepaper) 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 (Free ASCO Whitepaper) 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

(Press release, BioNTech, MAY 22, 2026, View Source [SID1234666009])