Daiichi Sankyo and AstraZeneca Report CHMP Positive Opinion for Enhertu + Perjeta to Treat HER2-Positive Metastatic Breast Cancer
Shots:
- The CHMP has recommended Enhertu (5.4mg/kg) + Perjeta for the 1L treatment of pts with HER2+ unresectable or metastatic breast cancer (MBC), backed by P-III (DESTINY-Breast09) trial data (n=1157)
- Trial assessed Enhertu ± Perjeta vs THP, where it improved PFS by 44% in 383 pts who had not received prior CT or HER2-targeted therapy, or had received neoadj./adj. HER2-targeted therapy for >6mos. before advanced/metastatic disease diagnosis
- mPFS was 40.7 vs 26.9mos., with consistent benefit across HR status, de novo/recurrent disease, & PIK3CA mutation subgroups. cORR was 85.1% vs 78.6%, incl. 58 vs 33 CRs & 268 vs 271 PRs, while mDOR was 39.2 vs 26.4mos. Data were published in THE NEJM
Ref: Businesswire | Image: Daiichi Sankyo& AstraZeneca | Press Release
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