BioNTech and Bristol Myers Extend Survival in Lung Cancer

BioNTech (Nasdaq: BNTX) and Bristol Myers Squibb (NYSE: BMY), in the global Phase 2 ROSETTA Lung-107 clinical trial tracking 50 patients, shared initial clinical results for the combination of pumitamig and docetaxel in patients with metastatic non-small cell lung cancer previously treated with immunotherapy and chemotherapy. Data presented at the European Society for Medical Oncology (ESMO) Congress 2026 in Madrid, Spain, demonstrated that treatment with the bispecific immunomodulator pumitamig showed marked antitumor activity in tumor control.

What results were obtained from the Phase 2 clinical trial?

The study evaluated the combination of pumitamig and docetaxel administered at a dose of 1,400 mg every 3 weeks. As of the July 10, 2026 data cutoff date, with a median follow-up of 12.2 weeks across 50 patients, 33 remained on treatment, while among 30 patients evaluable for efficacy, the confirmed objective response rate was 36.7% and the disease control rate was 90.0%. The median time to response was 1.4 months. Responses occurred regardless of PD-L1 expression levels, with a response rate of 57.1% in the squamous cell group and 30.4% in the non-squamous group.

What advantage does pumitamig treatment offer to patients?

In the cohort comprising all 50 treated patients, median progression-free survival was calculated at 6.9 months, while the 6-month progression-free survival rate reached 63.3%. Docetaxel, the standard chemotherapy agent in current treatment protocols, historically provided a median progression-free survival of 3.6 to 3.9 months in squamous and non-squamous metastatic cases progressing after immunotherapy and chemotherapy.

In the 50 patients included in the safety analysis, the pumitamig combination was reported to offer a manageable safety profile and produce no new safety signals. While treatment-related adverse events of any grade occurred in 52.0% of patients, Grade 3 and higher adverse events were limited to 18.0%; 4 patients discontinued treatment as a result. Prof. Dr. Ozlem Tureci, Co-Founder and Chief Medical Officer of BioNTech, stated that the clinical evidence supports the pumitamig strategy in a patient group with limited options. Cristian Massacesi, Executive Vice President and Chief Medical Officer at Bristol Myers Squibb, reported that 4 global Phase 3 trials are currently underway for the drug.

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