BioNTech and DualityBio's HER2 ADC wins a 'modest' Phase 3 in HR+/HER2-low breast cancer
- The global Phase 3 DYNASTY-Breast02 trial of trastuzumab pamirtecan met its primary progression-free survival endpoint against physician's-choice chemotherapy.
- Patients had chemotherapy-naive, HR+/HER2-low metastatic breast cancer that progressed on endocrine therapy.
- The companies themselves call the benefit statistically significant but modest; overall survival data are still immature, and they are weighing next steps.
💡 Points
When the sponsors call their own win 'modest' in HER2-low, where Enhertu is the benchmark, they are signalling that this ADC will not displace it on efficacy. The more realistic path is a narrower niche or combinations, and the choice of next step will show how much BioNTech still wants to carry a HER2 ADC next to its bispecific bets.
BioNTech, DualityBio ponder next steps for HER2 ADC after 'modest' breast cancer results ↗