Skip to main content
Premium Trial:

Request an Annual Quote

Merck, Eisai Discontinue Phase III Trial of Keytruda, Lenvima Combo Therapy

NEW YORK – Merck and Eisai on Friday said they will close the Phase III LEAP-010 trial of Merck's anti-PD-1 therapy Keytruda (pembrolizumab) and Eisai's tyroskine kinase inhibitor Lenvima (lenvatinib) as a first-line treatment for recurrent or metastatic head and neck squamous cell carcinoma whose tumors express PD-L1.

The decision follows a second interim analysis in which Keytruda-Lenvima failed to demonstrate an improvement in overall survival compared to Keytruda plus placebo, and the likelihood of reaching the threshold for statistical significance for overall survival was estimated to be low.

In the trial, investigators compared a treatment regimen comprising a 20 mg oral dose of Lenvima once a day and 200 mg Keytruda by intravenous infusion on day 1 of each 21-day cycle to a placebo with intravenous Keytruda on the same schedule. Dosing continued until disease progression or unacceptable toxicity occurred for up to 35 cycles. The primary outcome measures were objective response rate and progression-free survival.

In the first interim analysis, patients treated with Keytruda-Lenvima had a statistically significant improvement in progression-free survival and overall response rate compared to Keytruda plus placebo.

"Although the progression-free survival results from this study were encouraging, unfortunately, the combination did not result in an overall survival benefit for patients," Gregory Lubiniecki, VP of global clinical development for Merck, said in a statement. "We will apply lessons from this trial to help continue advancing research of this combination."

The LEAP-009 trial of Keytruda and Lenvima compared to chemotherapy in patients with recurrent or metastatic head and neck cancer will not be affected by the discontinuation of LEAP-010.