BioNTech and Bristol Myers report 36.7% response in lung-cancer trial
Pumitamig plus docetaxel showed early activity after immunotherapy and chemotherapy, but the Phase 2 study had no control arm.
Adrian Kessler
The confirmed objective response rate was 36.7 per cent as BioNTech SE NASDAQBNTX and Bristol Myers Squibb Company NYSEBMY reported Phase 2 pumitamig results on Sunday. The response analysis covered 30 efficacy-evaluable patients receiving pumitamig plus docetaxel, without a control arm to establish whether adding the antibody improved outcomes.
The companies' Oct. 25 release describes treatment after metastatic non-small cell lung cancer progressed on immunotherapy plus chemotherapy. The July 10 cutoff included 50 treated patients, with median follow-up of 12.2 weeks; the partners said the findings would inform further development in this setting.
BioNTech is a Germany-based global biopharmaceutical company with a commercial vaccine business and an expanding oncology pipeline. Pumitamig is an investigational antibody targeting PD-L1 and VEGF-A, combining two biological targets in a single medicine.
BioNTech closed at US$88.12 in New York at 4:00 p.m. EDT on Oct. 23, according to NASDAQBNTX. Bristol Myers closed at US$61.48 at 4:00 p.m. EDT on Oct. 23, according to NYSEBMY; both closes preceded the release.
ROSETTA Lung-107 tested pumitamig with docetaxel, with dose expansion using 1,400 milligrams of the antibody every three weeks. Its registered primary measures include safety and investigator-assessed confirmed objective response, while progression-free survival is secondary.
Among efficacy-evaluable patients, disease control reached 90 per cent. Across all treated patients, estimated median progression-free survival was 6.9 months, with a 95 per cent confidence interval running from 4.2 months to not reached.
The release compares that survival estimate with historical docetaxel results of approximately 3.6 months for non-squamous disease and 3.9 months for squamous disease. Those patients were outside this trial, so the comparison cannot isolate pumitamig's contribution; the release provides no randomized treatment comparison or FDA agreement on the design.
Pumitamig-related adverse events of grade 3 or higher occurred in 18 per cent of treated patients, and related events led to treatment discontinuation in four patients. There were no pumitamig-related deaths, but those attribution-specific figures do not describe all toxicity from the combination.
"These findings support continued investigation of pumitamig in this population with high unmet need," trial investigator Byoung Chul Cho, professor of medical oncology at Yonsei Cancer Center, said in the release.
Lung-Cancer Programmes Target Different Treatment Settings
Eli Lilly and Company NYSELLY also reported lung-cancer combination data on Oct. 25, with a confirmed response rate of 62 per cent among 77 patients receiving olomorasib plus chemoimmunotherapy. That study treated previously untreated disease with a KRAS G12C mutation, so its response rate cannot rank the drugs against each other.
Lilly expects initial randomized SUNRAY-01 data in the first half of 2027. BioNTech and Bristol Myers said four global Phase 3 lung-cancer trials of pumitamig were ongoing, but did not announce a dated next step for the second-line programme.
Read more: Lilly reports 14.5-month response duration with olomorasib lung-cancer combination
The broader iShares Biotechnology ETF stood at US$207.74 at the Oct. 23 close, at 4:00 p.m. EDT, according to NASDAQIBB. That provides a sector reference before the Sunday presentations, rather than a reaction to their findings.
BioNTech reported €16.6 billion in cash, cash equivalents and security investments as of June 30 in its Aug. 4 financial update. The balance is historical, and the trial release supplies no cash-runway forecast.
The next scheduled corporate checkpoint is BioNTech's Nov. 3 results and update, which will report third-quarter finances and provide a new corporate account of development progress.
