BioNTech and Bristol Myers Squibb reported a confirmed tumor response rate of 36.7% among 30 evaluable patients receiving pumitamig plus docetaxel after advanced non-small cell lung cancer progressed following immunotherapy and chemotherapy.
The global Phase 2 ROSETTA Lung-107 trial is an open-label, single-arm study, meaning it has no comparison group. It enrolled 59 patients with metastatic squamous or non-squamous disease.
At the July 10 data cutoff, 50 patients were included in the analysis, with median follow-up of 12.2 weeks. Thirty-three remained on treatment.
Among the 30 patients evaluable for efficacy, the disease control rate was 90%. Responses occurred across tumor types and levels of PD-L1 expression. Median time to response was 1.4 months.
In the overall treated population, early median progression-free survival was 6.9 months, and the estimated six-month progression-free survival rate was 63.3%. The findings do not establish superiority over docetaxel alone because the trial lacks a control arm.
Pumitamig is an investigational bispecific antibody targeting PD-L1 and VEGF-A. It is designed to support immune activity against tumors while inhibiting blood vessel growth that helps sustain them.
Pumitamig-related adverse events occurred in 52% of patients, with Grade 3 or higher events in 18%. Four patients, or 8%, discontinued treatment because of these events.
Immune-related adverse events occurred in 22%, including Grade 3 or higher events in 10%. Bleeding events affected 16% and were limited to Grade 1 or 2. No pumitamig-related deaths or dose-limiting toxicities occurred.
The companies will use the findings to guide further development in this second-line lung cancer setting.
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