Merck Receives the FDA Approval for Keytruda and Keytruda Qlex, Plus CT ± Avastin to Treat PD-L1+ Pt-Resistant Ovarian Carcinoma
Shots:
- The US FDA has approved Keytruda/Keytruda Qlex + paclitaxel ± Avastin for the treatment of adults with PD-L1+ (CPS ≥1) Pt-resistant epithelial ovarian, fallopian tube or primary peritoneal carcinoma, who have received 1 or 2 prior systemic therapy
- Approval was based on the P-III (KEYNOTE-B96/ENGOT-ov65) trial data assessing Keytruda (400mg, IV, Q6W) with CT ± Avastin vs PBO + CT ± Avastin in Pt-resistant recurrent ovarian cancer pts (n=643)
- Among 643 pts, 72% had PD-L1 CPS ≥1, 73% received Avastin, 46% had prior Avastin, & 47% had a Pt-free interval <3mos. The trial improved PFS by 28% (mPFS: 8.3 vs 7.2mos.) & reduced death risk by 24% (mOS: 18.2 vs 14mos.) in CPS ≥1 pts
Ref: Businesswire | Image: Merck | Press Release
Related News: Merck Initiates P-III (KANDLELIT-007) trial of Calderasib + Keytruda Qlex for KRAS G12C-Mutant Nonsquamous NSCLC
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