BioNTech and Bristol Myers' immunotherapy trial shows promising tumor shrinkage results.

BioNTech and Bristol Myers' immunotherapy showed encouraging tumor shrinkage in a phase II trial, according to recent reports. This is a significant breakthrough in the development of cancer treatments, and the companies are hopeful that their collaboration will lead to improved outcomes for patients. Merck & Co., Inc. specializes in pharmaceuticals, vaccines, and animal health products, with a global presence in the US, Europe, China, Japan, and other regions.

BioNTech SE (Nasdaq: BNTX) and Bristol Myers Squibb Company (NYSE: BMY) recently presented interim data from a global randomized Phase 2 trial evaluating pumitamig (BNT327/BMS986545), an investigational bispecific antibody targeting PD-L1 x VEGF-A, in combination with chemotherapy for patients with extensive-stage small cell lung cancer (ES-SCLC). The trial, conducted in patients with untreated ES-SCLC, showed encouraging antitumor activity and a manageable safety profile.

The data, presented at the IASLC 2025 World Conference on Lung Cancer in Barcelona, revealed a 76.3% confirmed objective response rate (cORR), a 100% disease control rate (DCR), and a median progression-free survival (mPFS) of 6.8 months. The trial included 43 patients who received pumitamig in combination with standard of care chemotherapy, with a discontinuation rate of 14%. Pumitamig-related treatment-emergent adverse events of Grade ≥3 were reported in 1 patient at dose level 1 and five patients at dose level 2.

The companies are optimistic about the potential of pumitamig to set a new standard of care for first-line ES-SCLC and beyond. A global randomized Phase 3 trial, ROSETTA LUNG-01 (NCT06712355), is ongoing to further evaluate the efficacy and safety of pumitamig plus chemotherapy versus atezolizumab plus chemotherapy as a first-line treatment in patients with untreated ES-SCLC.

The interim data presented at the IASLC 2025 conference add to the growing body of evidence indicating the potential of pumitamig to improve outcomes across a wide range of solid tumors. The companies are committed to continuing their collaboration to advance the development of pumitamig as a potential new treatment option with meaningful clinical benefit for patients.

References:

[1] https://www.globenewswire.com/news-release/2025/09/08/3146265/0/en/First-Disclosure-of-Global-Interim-Phase-2-Data-for-BioNTech-and-Bristol-Myers-Squibb-PD-L1xVEGF-A-Bispecific-Antibody-Pumitamig-BNT327-BMS986545-in-Patients-with-Extensive-Stage-S.html