The combination therapy of MSD’s Keytruda (pembrolizumab) and Eisai’s Lenvima (lenvatinib) has failed to meet its primary endpoints in a Phase III trial.

The Phase III LEAP-001 study (NCT03884101) evaluated the combination therapy as a first-line treatment in patients with advanced or recurrent endometrial carcinoma. The primary endpoints of the trial were a prespecified statistical improvement in overall survival (OS) and progression-free survival (PFS).

The setback follows the failure of Keytruda and AstraZeneca’s Lynparza (olaparib) combination therapy in Phase III KEYLYNK-008 trial (NCT03976362) in patients with metastatic squamous non-small cell lung cancer. The Phase III trial failed to meet its primary endpoint by not demonstrating an improvement in OS with Keytruda plus Lynparza, compared to Keytruda plus placebo.

Keytruda and Lenvima are high-grossing drugs for the respective companies. Keytruda generated $6.3bn in sales in Q3 FY 2023, as per MSD’s financials. Lenvima is forecasted to generate Y293bn ($1.613bn) in sales in FY 2023, as per Eisai’s Q2 FY 2023 financials.

Keytruda is an anti-PD 1 monoclonal antibody which is being evaluated as a combination therapy with the tyrosine kinase inhibitor drug, Lenvima as part of a LEAP clinical programme. The LEAP programme was developed as part of a strategic collaboration between MSD and Eisai to jointly develop and commercialise Lenvima in 2018.

The LEAP clinical programme has suffered failures in recent months. In August, the Phase III LEAP-010 trial (NCT04199104) evaluating the combination therapy failed to demonstrate improvement in OS compared to Keytruda and placebo combination in patients with recurrent or metastatic head and neck squamous cell carcinoma whose tumours express PD-L1. Following the results, the MSD and Eisai discontinued the trial.

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By GlobalData

In April, the Phase III LEAP-003 trial (NCT03820986) for Keytuda and Lenvima combination therapy in unresectable or metastatic melanoma was discontinued. The decision followed the independent data monitoring committee (DMC) recommendation based on the interim analysis showing no improvement in OS with the combination therapy compared to Keytruda and placebo combination. The OS improvement was one of the primary endpoints for the LEAP-003 trial.

In August 2022, the Phase III LEAP-002 trial (NCT03713593) evaluating the combination therapy in patients with unresectable hepatocellular carcinoma was discontinued. The combination therapy failed to meet the trial’s primary endpoints of overall survival and progression-free survival.

The combination therapy of Keytruda and Lenvima has been approved as the first-line therapy for advanced renal cell carcinoma in multiple countries, including the US. The combination therapy has also been approved for certain types of advanced endometrial carcinoma following prior systemic therapy in any setting.