BioNTech and Bristol Myers Squibb say their experimental cancer drug pumitamig has delivered encouraging early results in a global mid-stage study in advanced non-small cell lung cancer.
The development adds momentum to one of the most closely watched immuno-oncology programs in development.
The companies reported interim Phase 2 data from the ROSETTA Lung-02 trial, testing pumitamig (also known as BNT327 or BMS-986545) in combination with chemotherapy in patients with previously untreated advanced NSCLC. The results were presented at the 2026 ASCO Annual Meeting in Chicago.
The data showed encouraging anti-tumor activity, with high response rates observed in both non-squamous and squamous NSCLC and at each PD-L1 expression level.
“Despite significant immuno-oncology advances in the treatment of non-small cell lung cancer, most advanced diseases relapse on or after a PD-(L)1 checkpoint inhibitor treatment,1 indicating that targeting this immunologic pathway alone is insufficient to achieve durable responses,” said Solange Peters, Lead Investigator and Director of Oncology at the University Hospital of Lausanne, Switzerland.
“I am encouraged by the efficacy signal with this bispecific approach, showing robust responses across subtypes and PD-L1 levels, supporting the continued investigation of pumitamig and its potential to deliver improved outcomes for a broad range of patients with NSCLC.”
Across 40 response-evaluable patients, the combination achieved a confirmed objective response rate (cORR) of 57.1% in non-squamous disease and 68.4% in squamous disease, with disease control rate hitting 100%.
Even higher responses were seen at a lower dose level, where cORR reached 63.6% in non-squamous and 72.7% in squamous NSCLC.
Importantly, activity was consistent across biomarker subgroups. The safety profile was described as manageable, though not without notable toxicities. Grade ≥ 3 treatment-related adverse events occurred in 48.8% of patients, while immune-related adverse events were seen in 37.2%.
Bleeding events were reported in 20.9% of patients, with one grade 3 event recorded.
Experts involved in the study said the findings support further development of the drug.
BioNTech’s Chief Medical Officer, Özlem Türeci, highlighted the mechanism driving the drug’s design. “The data we are presenting today provide further evidence of the potential of pumitamig to enhance anti-tumor responses in advanced lung cancer, one of the most challenging indications, by simultaneously targeting PD-L1 and VEGF-A with a single molecule."
Bristol Myers Squibb also pointed to the breadth of its ongoing program and ambition to reshape standard of care. “We are committed to advancing the science of lung cancer with pumitamig and improving on the standard of care for people with this challenging disease,” said Anne Kerber, Senior Vice President, Head of Development, Hematology, Oncology, Cell Therapy at Bristol Myers Squibb.
“With one of the broadest registrational programs in the class, we are focused on accelerating the development of pumitamig together with BioNTech, with the goal of delivering meaningful benefit to patients, including those who have been left behind by current therapies.”
The drug is now moving deeper into late-stage development, with multiple global Phase 3 trials underway across lung cancer and other tumor types. These include head-to-head studies against current standards of care such as pembrolizumab and durvalumab.
