Biontech SE（BNTX）のニュースとイベントBNTXBiontech SE

BioNTech and DualityBiologics Announce DYNASTY-Breast02 Trial Meets Primary Endpoint

BioNTech and DualityBiologics announced that the DYNASTY-Breast02 global Phase 3 clinical trial met its primary endpoint demonstrating a statistically significant, yet modest improvement in progression-free survival, or PFS, with trastuzumab pamirtecan compared to investigator's choice of chemotherapy in chemotherapy-naive patients with HR+/HER2-low metastatic breast cancer who have progressed on endocrine therapy. At this interim analysis for the secondary endpoint of overall survival, or OS, data were not mature. A higher rate of interstitial lung disease, or ILD, was reported in this trial compared to prior trials with trastuzumab pamirtecan, with most cases being Grade 1 and 2. Severe and fatal events were reported in a small proportion of patients. Otherwise, the overall safety profile was consistent with prior clinical trials and no new safety signals were observed. The available efficacy and safety data, as of this data cut-off date, suggest that the potential benefit to patients would be limited in the context of the HR+/HER2-low metastatic breast cancer treatment landscape. The companies will discuss the data and determine next steps. BioNTech and DualityBio are developing trastuzumab pamirtecan in three ongoing clinical trials, including two global Phase 3 clinical trials, in HR+/HER2-low metastatic breast cancer and in HER2-expressing recurrent endometrial cancer, as well as in a global Phase 1/2 clinical trial in patients with advanced/metastatic solid tumors.

BioNTech and Bristol Myers Squibb Announce Lung Cancer Trial Data

BioNTech (BNTX) and Bristol Myers Squibb Company (BMY) 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 in patients with metastatic non-small cell lung cancer, NSCLC, whose disease progressed on or after first-line immunotherapy plus chemotherapy. Key highlights: Pumitamig plus docetaxel demonstrated encouraging responses in squamous and non-squamous non-small cell lung cancer across PD-L1 expression levels with a confirmed objective response rate of 36.7% following progression on or after immunotherapy plus chemotherapy; An early median progression-free survival of 6.9 months was observed; Significant unmet need remains for patients who have progressed on an immunotherapy-containing regimen, with the average progression-free survival below 4 months for standard of care docetaxel ; Data represent the third global Phase 2 dataset for pumitamig in lung cancer and reinforce its potential to improve outcomes over current standards of care

BioNTech Collaborates with Gilead on Clinical Trial

BioNTech (BNTX) announced a clinical trial collaboration and supply agreement with Gilead Sciences (GILD) to evaluate pumitamig in combination with the TROP2-directed antibody-drug conjugate sacituzumab govitecan as first-line treatment for patients with locally advanced or metastatic PD-L1 low or negative triple-negative breast cancer. Pumitamig is an investigational bispecific immunomodulator designed to cooperatively bind to PD-L1 and VEGF-A that is being jointly developed by BioNTech and Bristol Myers Squibb (BMY). Under the terms of the agreement, BioNTech will continue to sponsor and lead the ROSETTA Breast-01 trial. Gilead will supply sacituzumab govitecan for the combination trial.