Merck, Eisai provide update on Phase 3 trials, LEAP-006 and LEAP-008

Merck (MRK) and Eisai (ESAIY) provided updates on two Phase 3 trials, LEAP-006 and LEAP-008, evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, 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. LEAP-006: 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, a current standard of care option in this disease setting, as a first-line treatment for adult patients with metastatic, nonsquamous non-small cell lung cancer who have confirmation that epidermal growth factor receptor-, anaplastic lymphoma kinase- or c-ros oncogene 1-directed therapies are not indicated, did not meet its dual primary endpoints of overall survival and progression free survival. At the study’s final analysis, there was not an improvement in OS for patients treated with KEYTRUDA 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. LEAP-008: The Phase 3 LEAP-008 trial evaluating KEYTRUDA plus LENVIMA versus docetaxel, a current second line standard of care option, 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 OS and PFS. At the final analysis of the study, there was not an improvement in OS for patients who received KEYTRUDA plus LENVIMA compared to docetaxel. Earlier interim analyses did not demonstrate a statistically significant improvement in PFS or ORR, a key secondary endpoint. In both the LEAP-006 and LEAP-008 trials, the safety profiles of the KEYTRUDA plus LENVIMA-based treatment regimens were consistent with that observed in previously reported studies evaluating the combination. A full evaluation of the data from these studies is ongoing. The companies will work with investigators to share the results with the scientific community.