Phase 3 Breast Cancer Win Is Modest, With Higher Lung-Inflammation Rate
BNTX is trading near its 52-week low of $79.52 (11% above the low).
Summary
BioNTech and DualityBio said the DYNASTY-Breast02 Phase 3 trial of trastuzumab pamirtecan met its primary endpoint, a statistically significant but modest improvement in progression-free survival versus chemotherapy in HR+/HER2-low metastatic breast cancer. Overall survival data were not mature at this interim look. The bigger problem is safety: interstitial lung disease occurred at a higher rate than in prior trials of the drug, with Grade 3-5 severe and fatal cases in a small proportion of patients. The companies themselves said the available efficacy and safety data suggest the potential benefit to patients would be limited given the current treatment landscape, and they will discuss the data and determine next steps. That language undercuts the commercial case for one of BioNTech's lead ADC assets and comes after the October 13 disclosure that BNT113 missed its PFS endpoint in head and neck cancer.
Updates
· SEC 6-K — The DYNASTY-Breast02 trial randomized 541 patients with HER2-low expression 1:1 to trastuzumab pamirtecan or investigator's choice chemotherapy (capecitabine, paclitaxel or nab-paclitaxel).
At the time of this announcement, BNTX was trading at $88.37 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $22.1B. The 52-week trading range was $79.52 to $124.00. This news item was assessed with negative market sentiment and an importance score of 8 out of 10. Source: GlobeNewswire.