Merck and Eisai Reveal Latest Data from P-III (LEAP-015) Trial of Keytruda (pembrolizumab) and Lenvima (lenvatinib) Regimen to Treat Gastroesophageal Adenocarcinoma

Shots:

• P-III (LEAP-015) trial assessed Keytruda + Lenvima + CT (CAPOX or mFOLFOX6 regimen) as a 1L therapy for LA/M inoperable HER2- GE adenocarcinoma pts in 2 parts (P1: safety run-in & P2: main trial). LEAP program is also assessing it in hepatocellular carcinoma & esophageal cancer
• P2 pts (n=880) received Keytruda (400mg, IV Q6W, 2 cycles) + Lenvima (8mg, QD) + CT for ~12wks., followed by Keytruda (≤16 doses) + Lenvima (20mg, QD) or CT in consolidation phase. 1EPs were OS & PFS assessed in PD-L1+ (CPS ≥1) pts & all pts; 2EPs were ORR & DOR assessed in all pts
• Interim analysis showed improved PFS & ORR, failed to meet OS at the final analysis. Ongoing full evaluation data will be presented at future meetings; these results will not affect other ongoing trials

Ref: Merck & Eisai  | Image: Merck & Eisai

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