Update on two phase III trials evaluating Lenvima; (lenvatinib) plus Keytruda; (pembrolizumab) in patients with certain types of metastatic non-small cell lung cancer

LEAP-006: The Phase III LEAP-006 trial evaluating Lenvima plus Keytruda in combination with pemetrexed (Alimta) 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, non-squamous non-small cell lung cancer (NSCLC) who have confirmation that epidermal growth factor receptor (EGFR)-, anaplastic lymphoma kinase (ALK)- or c-ros oncogene 1 (ROS1)- directed therapies are not indicated, did not meet its dual primary endpoints of overall survival (OS) and progression free survival (PFS). 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 (ORR), a key secondary endpoint.

LEAP-008: The Phase III LEAP-008 trial evaluating Lenvima plus Keytruda 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 Lenvima plus Keytruda-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.

“Despite great progress in recent years, unmet needs still remain in the treatment of patients with metastatic non small cell lung cancer, particularly for those without targetable biomarkers,” said Dr. Corina Dutcus, Senior Vice President, Global Clinical Development, Oncology at Eisai Inc. “Keytruda plus Lenvima has demonstrated survival benefit in advanced renal cell carcinoma and advanced endometrial carcinoma, and while we are disappointed that the final analyses of these non-small cell lung cancer studies did not show the same benefit, we remain committed to applying learnings from these studies and furthering research in oncology for people with unmet needs. We thank all the patients, their families and the investigators involved.”

Lenvima plus Keytruda is approved in the U.S., the EU, Japan and other countries for the treatment of advanced renal cell carcinoma (RCC) and certain types of advanced endometrial carcinoma. Lenvatinib is marketed as Kisplyx for advanced RCC in the EU. Eisai and Merck & Co., Inc., Rahway, NJ, USA are studying the Lenvima plus Ketruda combination through the LEAP (LEnvatinib And Pembrolizumab) clinical program in various tumor types, including but not limited to endometrial carcinoma, hepatocellular carcinoma, RCC, head and neck cancer, gastric cancer and esophageal cancer across multiple clinical trials. Results from the LEAP-006 and LEAP-008 trials do not affect the current approved indications for the Lenvima and Keytruda combination or other ongoing trials from the LEAP clinical program.