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BioNTech and Bristol Myers Squibb Report Encouraging Global Phase 2 Data for Pumitamig in Advanced NSCLC After Progression on Immunotherapy Plus Chemotherapy

$BMYPress releaseOct 25, 2026, 3:29 AM ETRead the release

Bristol Myers Squibb and BioNTech announced first data from the Phase 2 ROSETTA Lung-107 trial of pumitamig plus docetaxel in second-line metastatic NSCLC, presented as a late-breaker at ESMO 2026. Among 30 efficacy-evaluable patients, the combination showed a confirmed objective response rate of 36.7% and disease control rate of 90.0%, with median PFS of 6.9 months versus roughly 3.6-3.9 months historically for standard-of-care docetaxel. Responses were consistent across PD-L1 expression levels and both squamous and non-squamous histologies, with a manageable safety profile and no new safety signals in 50 patients.

Key figures

Drug Name
pumitamig (BNT327/BMS986545)
Phase Of Trial
Phase 2
Confirmed orr
36.7%
Grade3 trae rate
18.0%
Patients treated
50
Median pfs months
6.9
Six month pfs rate
63.3%
Disease control rate
90.0%
Median followup weeks
12.2
Patients efficacy evaluable
30

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