BioNTech and Bristol Myers Squibb reported promising interim Phase 2 results from the ROSETTA Lung-02 trial of pumitamig, a bispecific PD-L1/VEGF-A antibody plus chemotherapy in advanced NSCLC, showing strong efficacy across subtypes and manageable safety as late-stage development advances.
Written By: Sana Khan BPharm
Reviewed By: Pharmacally Editorial Team
BioNTech and Bristol Myers Squibb presented encouraging interim Phase 2 results from the global Phase 2/3 ROSETTA Lung-02 trial (NCT06712316) evaluating pumitamig (BNT327/BMS-986545), a bispecific antibody targeting PD-L1 and VEGF-A, in combination with chemotherapy for previously untreated advanced non-small cell lung cancer (NSCLC).
Data presented during a rapid oral session at the 2026 ASCO Annual Meeting demonstrated strong anti-tumor activity across both non-squamous and squamous NSCLC, as well as across all PD-L1 subgroups.
Pumitamig simultaneously blocks PD-L1-mediated immune suppression and VEGF-A-driven angiogenesis, two pathways that contribute to tumor growth and resistance to immunotherapy. The dual-targeting approach aims to enhance anti-tumor immune responses while reshaping the tumor microenvironment, potentially improving outcomes beyond those achieved with PD-(L)1 inhibition alone.
Efficacy Outcomes
At the April 13, 2026 data cutoff, 40 response-evaluable patients had a median follow-up of 9.0 months. Confirmed objective response rates (cORR) reached 57.1% in patients with non-squamous NSCLC and 68.4% in those with squamous NSCLC. Disease control rates were 100% in both groups.
Responses were observed at both dose levels, with numerically higher activity at the lower dose. In this cohort, cORR reached 63.6% in non-squamous disease and 72.7% in squamous disease.
Clinical activity was also consistent across PD-L1 expression categories. Confirmed response rates were 47.6% among patients with PD-L1 tumor proportion scores (TPS) below 1%, 77.8% among those with TPS between 1% and 49%, and 100% among patients with TPS of 50% or higher.
Safety Profile
The regimen demonstrated a manageable safety profile. Grade 3 or higher treatment-related adverse events occurred in 48.8% of patients and were considered pumitamig-related in 23.3%. Four patients (9.3%) discontinued treatment because of adverse events.
Immune-related adverse events were reported in 37.2% of patients, while grade 3 or higher immune-related events occurred in 4.7%. Bleeding events occurred in 20.9% of patients, with only one grade 3 event reported.
Overall, the safety profile appeared manageable, with low treatment discontinuation rates and no new safety signals reported.
Strategic Context
Lead investigator Solange Peters, MD, PhD, highlighted the need for treatment strategies that extend beyond PD-(L)1 blockade alone, noting that many patients with advanced NSCLC eventually relapse following immunotherapy. The findings suggest that simultaneous inhibition of PD-L1 and VEGF-A may help broaden and deepen clinical responses across patient populations.
BioNTech Chief Medical Officer Özlem Türeci, MD, emphasized that pumitamig has now demonstrated encouraging efficacy signals across multiple global Phase 2 studies and across PD-L1 expression levels. The numerically higher response rates observed at the lower dose may help guide ongoing late-stage development and dose optimization efforts.
Late-Stage Development
ROSETTA Lung-02 is currently recruiting patients for its Phase 3 portion. Two additional global Phase 3 studies are also underway. ROSETTA Lung-201 is evaluating pumitamig following concurrent chemoradiation in patients with unresectable Stage III NSCLC, while ROSETTA Lung-202 is comparing the therapy with pembrolizumab in the first-line treatment of advanced NSCLC with PD-L1 TPS of at least 50%.
With three global Phase 3 trials now underway, BioNTech and Bristol Myers Squibb are positioning pumitamig as a potential next-generation immunotherapy platform in lung cancer. Upcoming registrational studies will determine whether the early efficacy signals translate into durable clinical benefit and a new treatment option for patients with NSCLC.
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About the Writer
Sana Jamil Khan (LinkedIn) is a B. Pharm graduate with a strong interest in medical writing and scientific communication. Her work focuses on interpreting clinical research, exploring developments in pharmaceutical science, and presenting complex medical information in a clear and accessible manner. She is particularly interested in topics related to human clinical studies, drug safety observations, and emerging therapeutic research.