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Announces modest PFS improvement for trastuzumab pamirtecan in HR+/HER2-low breast cancer trial
BNTXBioNTech SE
BioNTech SE and DualityBiologics announced topline results from the global Phase 3 DYNASTY-Breast02 clinical trial evaluating trastuzumab pamirtecan. The study met its primary endpoint, demonstrating a statistically significant but modest improvement in progression-free survival compared to chemotherapy in patients with HR+/HER2-low metastatic breast cancer who progressed on endocrine therapy. Overall survival data were not mature at this interim analysis. A higher rate of interstitial lung disease was observed, though most cases were Grade 1 or 2. The companies stated that the limited potential benefit suggests they will discuss next steps regarding the drug's development in this indication. BioNTech SE is a global biopharmaceutical company pioneering novel investigative therapies for cancer and other serious diseases.