Positive high-level results from the pivotal DESTINY-Breast04 Phase III trial showed Enhertu (trastuzumab deruxtecan) demonstrated a statistically-significant and clinically-meaningful improvement in both progression-free survival (PFS) and overall survival (OS) in patients with HER2-low unresectable and/or metastatic breast cancer regardless of hormone receptor (HR) status versus physician’s choice of chemotherapy.
Enhertu is a HER2-directed antibody drug conjugate (ADC) being jointly developed by UK pharm major AstraZeneca (LSE: AZN) and Japan’s Daiichi Sankyo (TYO: 4568). Enhertu is forecast by some analysts to have the potential for peak sales of $7 billion.
All patients in the trial received a HER2 test, and the results were centrally confirmed. HER2-low status was defined as an immunohistochemistry (IHC) score of 1+ or IHC 2+ with a negative in-situ hybridization (ISH) score.
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