BioNTech and DualityBio Announce Topline Results of the DYNASTY-Breast02 Global Phase 3 Clinical Trial Evaluating Trastuzumab Pamirtecan in HR+/HER2-low Metastatic Breast Cancer
BioNTech and DualityBio announced that the DYNASTY-Breast02 Phase 3 trial of trastuzumab pamirtecan (BNT323/DB-1303) met its primary endpoint, showing a statistically significant but modest PFS improvement versus chemotherapy in HR+/HER2-low metastatic breast cancer. The signal is clouded: interim OS data were not mature, and a higher rate of interstitial lung disease was reported versus prior trials, with severe and fatal events in a small proportion of patients.
Key figures
- Drug Name
- trastuzumab pamirtecan (BNT323/DB-1303)
- Phase Of Trial
- Phase 3
- Nct id
- NCT06018337
- Os status
- not mature at interim analysis
- Indication
- HR+/HER2-low metastatic breast cancer
- Trial name
- DYNASTY-Breast02
- Primary endpoint
- PFS met with statistically significant but modest improvement
- Patients randomized
- 541
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