BioNTech, DualityBio Breast Cancer Drug Shows Modest Progression-Free Survival Benefit in Phase 3 Trial
- BioNTech and DualityBio reported trastuzumab pamirtecan met the primary endpoint in the Phase 3 DYNASTY-Breast02 trial.
- Progression-free survival improved significantly but modestly versus chemotherapy in chemotherapy-naive patients with HR-positive, HER2-low metastatic breast cancer progressing 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 see limited potential benefit relative to available treatments and will review the data to decide next steps.
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