BioNTech, BMS report Phase 2 pumitamig data in NSCLC after immunotherapy progression

BioNTech SE and Bristol Myers Squibb Company announced on October 25, 2026 the first data from the global Phase 2 "ROSETTA Lung-107" trial (NCT06841055), testing pumitamig plus docetaxel in patients with metastatic non-small cell lung cancer whose disease progressed after first-line immunotherapy plus chemotherapy. The combination showed a confirmed objective response rate of 36.7% across PD-L1 expression levels and both squamous and non-squamous histology, following progression on immunotherapy plus chemotherapy, with an early median progression-free survival of 6.9 months, compared with an average PFS below 4 months for standard-of-care docetaxel.¹ The data were presented in a late-breaking rapid oral presentation (abstract #LBA76) at the ESMO Congress 2026 in Madrid, Spain.¹

As of a July 10, 2026 cutoff, 50 patients had a median follow-up of 12.2 weeks, with 33 remaining on treatment; among 30 efficacy-evaluable patients, the disease control rate was 90.0%.¹ Across the overall treated population of 50, median PFS was 6.9 months (95% CI: 4.2 to not reached), with a six-month PFS rate of 63.3%.¹ On safety, treatment-related adverse events of any grade occurred in 52.0% of patients and grade 3 or higher in 18.0%, with immune-related AEs in 22.0% of patients and no pumitamig-related deaths or dose-limiting toxicities.¹

This update follows BioNTech's October 22, 2026 announcement of a collaboration and supply agreement with Gilead Sciences to modify the Phase 3 ROSETTA Breast-01 trial, under which BioNTech and BMS plan to replace chemotherapy with sacituzumab govitecan in the trial regimen, pending regulatory authority approval, to reflect the latest standard of care for patients.² That announcement itself followed BioNTech's October 19, 2026 disclosure that it would present 16 abstracts on its oncology pipeline at ESMO 2026, held October 23 to 27, 2026, in Madrid.