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BioNTech & DualityBio reported topline P-III (DYNASTY-Breast02) results of trastuzumab pamirtecan (BNT323/DB-1303) vs investigator’s choice CT in CT-naïve pts (n=541) with HR+/HER2-low mBC who progressed on ET
The trial met its 1EP with a statistically significant but modest PFS improvement, while OS data were immature at the interim analysis; ILD rates were higher than in prior trials, mostly Grade 1/2, with severe & fatal events (Grade 3-5) in a small proportion of pts
The companies said potential benefit would be limited in the HR+/HER2-low mBC landscape & will discuss the data to determine next steps
Ref: GlobeNewswire | Image: BioNTech | Press Release
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The post BioNTech and DualityBio Report Topline P-III (DYNASTY-Breast02) Trial Results of Trastuzumab Pamirtecan for HR+/HER2-Low Metastatic Breast Cancer appeared first on PharmaShots.
BioNTech and DualityBio Report Topline P-III (DYNASTY-Breast02) Trial Results of Trastuzumab Pamirtecan for HR+/HER2-Low Metastatic Breast Cancer | PharmaVoice