The approval was based on the P-III head-to-head (DESTINY-Breast03) trial that evaluates Enhertu (5.4mg/kg) vs T-DM1 (3.6mg/kg) in 524 patients with HER2+ unresectable & metastatic breast cancer prior treated with trastuzumab & taxane at multiple sites in Asia, EU, North America, Oceania & South America
The results showed a 72% reduction in risk of disease progression or death, m-PFS (not reached vs 6.8mos.). At the time of the PFS analysis, 16.4% had died, OS was immature, ORR (79.7% vs 34.2%)
The safety profile was consistent with prior trials. Enhertu is a HER2-directed ADC that consists of HER2 mAb attached to topoisomerase I inhibitor payload, an exatecan derivative via a stable tetrapeptide-based cleavable linker
Ref: AstraZeneca | Image: AstraZeneca
