BioNTech SE (BNTX) Form 6-K — Oct 26, 2026
BioNTech and partner DualityBio announced topline results from the DYNASTY-Breast02 global Phase 3 trial of trastuzumab pamirtecan (BNT323/DB-1303) in HR+/HER2-low metastatic breast cancer. The trial met its primary endpoint with a statistically significant, yet modest, PFS improvement versus investigator's choice chemotherapy, and OS data were not mature at this interim analysis. Safety showed a higher rate of interstitial lung disease than in prior trials, with most cases Grade 1-2 but severe and fatal Grade 3-5 events reported in a small proportion of patients. No other new safety signals were observed.
Key figures
- Trial
- DYNASTY-Breast02 (NCT06018337)
- Endpoint
- PFS met with statistically significant but modest improvement; OS data not mature
- Patients randomized
- 541
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