Merck: LEAP-006, LEAP-008 Trials Fails To Meet Dual Primary Endpoints

(RTTNews) - Merck (MRK) and Eisai today provided updates on two Phase 3 trials, LEAP-006 and LEAP-008, evaluating KEYTRUDA, plus LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, in patients with certain types of metastatic non-small cell lung cancer.

The Phase 3 LEAP-006 trial evaluating KEYTRUDA plus LENVIMA in combination with pemetrexed and platinum-containing chemotherapy versus KEYTRUDA with pemetrexed and platinum-containing chemotherapy as a first-line treatment for adult patients with metastatic, nonsquamous non-small cell lung cancer did not meet its dual primary endpoints of overall survival and progression free survival.

The Phase 3 LEAP-008 trial evaluating KEYTRUDA plus LENVIMA versus docetaxel as a treatment for patients with metastatic NSCLC who progressed on or after platinum-containing chemotherapy and one prior anti-PD-1/-L1 immunotherapy, and have confirmation that EGFR-, ALK- or ROS1-directed therapies are not indicated, did not meet its dual primary endpoints of overall survival and progression free survival.

The company noted that the results from the LEAP-006 and LEAP-008 trials do not affect the current approved indications for the KEYTRUDA plus LENVIMA combination or other ongoing trials from the LEAP clinical program.

KEYTRUDA plus LENVIMA is approved in the U.S., the EU, Japan and other countries for the treatment of advanced renal cell carcinoma and certain types of advanced endometrial carcinoma.

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