Bumitamig and docetaxel combination posts 36.7% response rate in lung cancer
Key Facts
BioNTech and Bristol Myers Squibb on October 25, 2026, announced the first global Phase 2 data for bumitamig with docetaxel in patients with metastatic non-small cell lung cancer. In the efficacy-evaluable group of 30 patients, the confirmed objective response rate was 36.7%, while the disease control rate reached 90.0%. The study included patients whose disease progressed during or after first-line chemo-immunotherapy. The results are an early signal of activity for the combination in this treatment setting. But the study is open-label and single-arm, so it does not provide a direct comparison with a control group.
Among all 50 patients who received treatment, median progression-free survival was 6.9 months, and the six-month progression-free survival rate was 63.3%. The companies compared this result with historical estimates for docetaxel after chemo-immunotherapy, in which median progression-free survival was about 3.6 months for non-squamous disease and 3.9 months for squamous disease. These figures provide context for the result, but they do not represent a randomized comparison of the two treatments in the same study. The difference therefore must be viewed in light of the different comparison design and does not by itself establish the combination’s superiority. The survival data also came from an early analysis of treated patients.
The analysis was based on a data cutoff of July 10, 2026, when median follow-up was 12.2 weeks and 33 of the 50 patients were still receiving treatment. Confirmed response varied by PD-L1 expression level: 42.9% among those with a level below 1%, 33.3% among those with levels from 1 to 49%, and 40.0% among those at 50% or higher. By tumor type, the rate was 57.1% in squamous tumors versus 30.4% in non-squamous tumors. These results show subgroup readings within the study sample. They break down what the study recorded by patient and tumor characteristics, alongside the overall rate.
In safety data, immune-related adverse events occurred in 22.0% of patients, and VEGF-related events in 26.0%. The companies said there were no deaths related to bumitamig or dose-limiting toxicities. The study evaluates a dose of 1400 mg of bumitamig with docetaxel every three weeks. This provides details on the tested treatment regimen alongside the reported safety indicators. These figures remain part of the early results readout alongside the efficacy data.
ROSETTA Lung-107 enrolled 59 patients at sites in Australia, South Korea, Spain, Turkey, the United Kingdom and the United States. It is a global, open-label, single-arm Phase 2 study involving patients with Stage 4 squamous or non-squamous lung cancer whose disease progressed after first-line chemo-immunotherapy. These criteria place the results in the context of a defined patient group, not all lung cancer cases or everyone who has previously received treatment. The announcement came as BioNTech attended the ESMO 2026 conference in Madrid, running from October 23 to 27. The company had announced a conference program comprising 16 research abstracts across ten tumor types.
The bumitamig data are part of a broader development program that the companies said includes seven ongoing global Phase 3 trials. The ROSETTA Lung-107 announcement provides Phase 2 data for the drug with docetaxel after disease progression following chemo-immunotherapy. The results announced here come from an analysis of 50 patients, with relatively short median follow-up at the data cutoff. BioNTech shares closed at $88.12 on October 23, 2026, two days before the data announcement. The closing price alone did not include details on the stock’s movement during the session.