BioNTech's Dual Readouts: A Lung-Cancer Combo Delivers, While a Breast-Cancer Candidate Poses Hard Questions
Published on 11/03/2026 at 07:20 | Editorial boerse-global.de
BioNTech and Bristol Myers Squibb disclosed on 25 October a confirmed objective response rate of 36.7% for pumitamig combined with docetaxel, drawn from the ROSETTA Lung-107 study in advanced non-small cell lung cancer. Thirty patients were evaluable for efficacy. The participants had already undergone immunotherapy and chemotherapy, and their disease had progressed during or after that first-line treatment, according to the two companies. Preliminary median progression-free survival in the phase-2 trial came in at 6.9 months, and the safety profile was described as manageable. BioNTech filed a mandatory Form 6-K disclosure alongside the results.
Pumitamig also anchors a collaboration with Gilead Sciences unveiled roughly two weeks earlier. Under that arrangement, the partners intend to test the drug alongside sacituzumab govitecan — marketed as Trodelvy — in advanced triple-negative breast cancer with low or absent PD-L1 expression. Gilead is to supply sacituzumab govitecan, while BioNTech and Bristol Myers Squibb plan to swap out chemotherapy for the drug in the first-line ROSETTA Breast-01 study, subject to regulatory clearance. BioNTech would remain sponsor and operator of the phase-3 trial.
The picture is far less flattering for trastuzumab pamirtecan, developed with DualityBio. In the phase-3 DYNASTY-Breast02 trial, reported on 26 October, the primary endpoint was met: progression-free survival improved by a statistically significant margin over physician's choice of chemotherapy. That margin, however, was modest. Overall survival data had not yet matured. The study enrolled patients with metastatic, hormone-receptor-positive breast cancer and low HER2 expression.
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Safety raised its own flags. Interstitial lung disease appeared more frequently than in earlier trials, with a small share of grade 3 to 5 events; Reuters reported that the tally included severe and fatal cases. In the current treatment landscape, the companies conceded, the potential benefit to patients may be limited. They said they will review the findings and determine next steps — and the 26 October announcement carried no decision on how to proceed.
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