Recent Updates — BNTX
BioNTech SE and Bristol Myers Squibb announced first data from the global Phase 2 ROSETTA Lung-107 clinical trial evaluating pumitamig, an investigational PD-L1xVEGF-A bispecific immunomodulator, in combination with docetaxel for patients with metastatic non-small cell lung cancer (NSCLC) who progressed after first-line therapy. The data showed a confirmed objective response rate of 36.7% and a median progression-free survival of 6.9 months across squamous and non-squamous histologies and PD-L1 expression levels, with a manageable safety profile. These findings support continued investigation of pumitamig in this high unmet need population as part of a broader development program including multiple Phase 3 trials. BioNTech is a global biopharmaceutical company pioneering novel investigative therapies for cancer.
BioNTech SE and DualityBiologics announced topline results from the global Phase 3 DYNASTY-Breast02 clinical trial evaluating trastuzumab pamirtecan. The study met its primary endpoint, demonstrating a statistically significant but modest improvement in progression-free survival compared to chemotherapy in patients with HR+/HER2-low metastatic breast cancer who progressed on endocrine therapy. Overall survival data were not mature at this interim analysis. A higher rate of interstitial lung disease was observed, though most cases were Grade 1 or 2. The companies stated that the limited potential benefit suggests they will discuss next steps regarding the drug's development in this indication. BioNTech SE is a global biopharmaceutical company pioneering novel investigative therapies for cancer and other serious diseases.
BioNTech entered a clinical trial collaboration and supply agreement with Gilead Sciences to evaluate the investigational bispecific immunomodulator pumitamig in combination with Gilead's TROP2-directed antibody-drug conjugate sacituzumab govitecan. The partnership modifies the ongoing global Phase 3 ROSETTA Breast-01 trial, replacing chemotherapy with sacituzumab govitecan as the standard of care for first-line treatment of locally advanced or metastatic PD-L1 low or negative triple-negative breast cancer. BioNTech will continue to sponsor and lead the trial, while Gilead supplies the drug. Pumitamig is jointly developed by BioNTech and Bristol Myers Squibb. BioNTech operates as a global biopharmaceutical company pioneering novel investigative therapies for cancer.
BioNTech announced first topline results from the Phase 2/3 AHEAD-MERIT clinical trial for its investigational mRNA cancer immunotherapy candidate BNT113. The trial did not meet its first dual primary endpoint of progression-free survival (PFS) when comparing BNT113 plus pembrolizumab against pembrolizumab alone in patients with metastatic HPV16-positive head and neck squamous cell carcinoma. However, the Independent Data Monitoring Committee recommended continuing the trial to evaluate the second dual primary endpoint of overall survival (OS). Under the pre-specified statistical design, a statistically significant improvement in OS would establish a positive outcome despite the PFS result. BioNTech is a global biopharmaceutical company pioneering novel investigative therapies for cancer and other serious diseases.