The Phase 3 LEAP-008 trial evaluating Keytruda plus Lenvima versus docetaxel for metastatic NSCLC 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 OS and PFS. 

At the study's final analysis, there was no improvement in OS for patients treated with Keytuda plus Lenvima with chemotherapy compared to Keytruda with chemotherapy. 

Earlier interim analyses did not demonstrate a statistically significant improvement in PFS or objective response rate, a key secondary endpoint.

In the LEAP-006 and LEAP-008 trials, the safety profiles of the Keytruda plus Lenvima-based treatment regimens were consistent with those observed in previously reported studies.

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

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