Complete Response from FDA for Keytruda + Lenvima combination to treat hepatocellular carcinoma ( Liver Cancer)- Merck Inc. + Eisai

Eisai Co., Ltd. and Merck & Co., Inc., announced that the FDA has issued a Complete Response Letter (CRL) regarding Eisai’s and Merck’s applications seeking accelerated approval of Lenvima, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, plus Keytruda, Merck’s anti-PD-1 therapy, for the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC) ( Liver Cancer).

The applications were based on data from the Phase 1b Study 116/KEYNOTE-524 trial, which showed clinically meaningful efficacy in the single-arm setting. These data were recently presented at the 2020 American Society of Clinical Oncology Annual Meeting and supported a Breakthrough Therapy designation granted by the FDA in July 2019. Ahead of the PDUFA action dates of Eisai’s and Merck’s applications, another combination therapy was approved based on a randomized controlled trial that demonstrated overall survival. Consequently, the CRL stated that the applications do not provide evidence that Keytruda in combination with Lenvima represents a meaningful advantage over available therapies for the treatment of unresectable or metastatic HCC with no prior systemic therapy for advanced disease.

Since the applications for Study 116/KEYNOTE-524 no longer meet the criteria for accelerated approval, both companies plan to work with the FDA to take appropriate next steps, which include conducting a well-controlled clinical trial that demonstrates substantial evidence of effectiveness and the clinical benefit of the combination. As such, LEAP-002, the Phase III trial evaluating the Lenvima plus Keytruda combination as a first-line treatment for advanced HCC, is currently underway and fully enrolled. The CRL does not impact the current approved indications for Lenvima or for |Keytruda