BioNTech, DualityBio breast cancer drug shows modest progression-free survival benefit in Phase 3 trial
BNTX•BioNTech and DualityBio said trastuzumab pamirtecan met the primary endpoint in the Phase 3 DYNASTY-Breast02 trial, with a significant but modest progression-free survival benefit versus chemotherapy. Interim overall survival data were immature, and interstitial lung disease included some severe or fatal cases.
1. Trial results and safety
Trastuzumab pamirtecan improved progression-free survival significantly but modestly versus chemotherapy in chemotherapy-naive patients with HR-positive, HER2-low metastatic breast cancer whose disease had progressed on endocrine therapy. Interim overall survival data were not yet mature. Interstitial lung disease occurred more frequently than in earlier studies; most cases were mild or moderate, but some were severe or fatal. The partners said they saw limited potential benefit relative to available treatments and would review the data to decide next steps.
