BioNTech and Bristol Myers Squibb reported early results from ROSETTA Lung-107, a Phase 2 trial of investigational pumitamig plus docetaxel for metastatic non-small cell lung cancer (NSCLC) that progressed after first-line immunotherapy and chemotherapy. Among 30 patients whose tumors could be evaluated, 36.7% had a confirmed response and 90.0% had disease control. The findings are an early signal—not proof that pumitamig improves outcomes beyond docetaxel alone.
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What ROSETTA Lung-107 reported
The companies presented the global, open-label study as late-breaking rapid oral abstract LBA76 at the ESMO 2026 congress in Madrid on October 25.
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8 Pumitamig, an investigational PD-L1×VEGF-A bispecific immunomodulator, was given at 1,400 mg every three weeks with docetaxel.
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At the July 10, 2026 data cutoff, 50 patients had received treatment. Median follow-up was 12.2 weeks, and 30 patients were evaluable for tumor response.
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Among those 30 patients, the confirmed objective response rate was 36.7%, while the disease control rate was 90.0%. The companies reported responses across PD-L1 expression levels and in both squamous and non-squamous NSCLC; the cited reports do not provide numerical response rates for those subgroups.
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In the full group of 50 treated patients, median progression-free survival (PFS)—the time patients lived without their disease worsening—was 6.9 months. The reported six-month PFS rate was 63.3%.
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Safety findings and what remains unclear
Reports summarized pumitamig-related adverse events in 52% of patients, with grade 3 or higher events in 18% and discontinuations in 8%. They also reported no pumitamig-related deaths or dose-limiting toxicities.
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19 These figures should be read in the context of a 50-patient safety population and short median follow-up. The available reports do not provide a reliable bleeding rate for this trial.
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The results do not establish how the combination compares with docetaxel alone or historical docetaxel outcomes. ROSETTA Lung-107 had no control arm, so it cannot isolate pumitamig’s contribution to the responses or PFS observed.
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12 The small number of evaluable patients and brief follow-up also make the findings preliminary.
What the results mean
The response and PFS findings support further study of pumitamig plus docetaxel in this second-line setting, but they do not establish a new standard of care. A randomized comparison would be needed to determine whether adding pumitamig improves outcomes over docetaxel alone.
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