Merck and Eisai Announce Failure of Two Phase III Trials of 'K-Lens' Combination in First- and Second-Line NSCLC

On September 22, MSD/Eisai jointly announced the latest progress of two Phase III LEAP-006 and LEAP-008 studies on the combination therapy of PD-1 treatment Keytruda (pembrolizumab) and tyrosine kinase inhibitor (TKI) Lenvima (lenvatinib), known as the "Kela Combination," for non-small cell lung cancer (NSCLC). Unfortunately, neither of these studies met the dual primary endpoints of overall survival (OS) and progression-free survival (PFS).

LEAP-006 Study Evaluates the Efficacy and Safety of Keytruda + Lenvatinib + Chemotherapy vs. Keytruda + Chemotherapy (Standard of Care) as First-Line Treatment in Patients with Metastatic Non-Squamous Non-Small Cell Lung Cancer. Results Show the Study Did Not Meet the Dual Primary Endpoints of OS and PFS.

LEAP-008 Study Aims to Evaluate the Efficacy and Safety of Keytruda + Lenvatinib + Chemotherapy vs. Keytruda + Chemotherapy (Standard Therapy) in Patients with Metastatic Non-Small Cell Lung Cancer Who Progressed After PD-(L)1 + Chemotherapy. The Results Showed That the Study Did Not Meet the Dual Primary Endpoints of OS and PFS.

In terms of safety, the safety profile of Keytruda + Lenvatinib in the two studies was consistent with what has been reported in previous studies, with no new safety signals identified.

"Kela Combination" has been approved in the United States, the European Union, Japan, and other regions for the treatment of advanced renal cell carcinoma (RCC) and specific types of endometrial cancer. MSD stated that the failures of the LEAP-006 and LEAP-008 studies will not affect the already approved indications of the "Kela Combination" or the ongoing clinical trials.

Moreover, the Phase III LEAP-010 study of the "Kela combination" for first-line treatment of tumors expressing PD-L1, recurrent or metastatic head and neck squamous cell carcinoma (HNSCC), also announced failure last month ().

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