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Keytruda/Lenvima combo shows positive action in range of cancers

September 21, 2020

Merck (NYSE:MRK) and Eisai (OTCPK:ESALY) announce new data from two clinical trials evaluating the combination of Keytruda (pembrolizumab) and Lenvima (lenvatinib) in patients with a range of cancers. The results were presented at ESMO.

In the Phase 2 LEAP-004 study, patients with unresectable or advanced melanoma who had progressed on anti-PD-1/L1 therapy showed a 21.4% (n=22/103) overall response rate (ORR), including two complete responders and 20 partials. Median duration of response (DOR) was 6.3 months. Median progression-free survival (PFS) was 4.2 months although 73.8% of patients progressed or died. Median overall survival (OS) was 13.9 months. OS at month 9 was 65.4%.

In the Phase 2 LEAP-005 study, patient with previously treated solid tumors, including triple-negative breast, ovarian, gastric, biliary tract and colorectal cancers, glioblastoma multiforme and showed ORRs of 9.7 – 32.3%. Disease control rates (responders + stable cancer) ranged from 46.9 – 74.2%.

On the safety front, the rates of serious or greater treatment-emergent adverse events (TEAEs) ranged from 35 – 68%. There was one treat-related death in each arm except biliary tract cancer.

The trial is ongoing.

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