The Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Merck and Eisai regarding applications seeking accelerated approval for Keytruda (pembrolizumab) in combination with Lenvima (lenvatinib) for the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC).
The applications included data from the multicenter, open-label, phase 1b KEYNOTE-524/Study 116 trial that evaluated the combination therapy in 100 patients with unresectable HCC who did not receive prior systemic therapy. Results, which were presented at the 2020 American Society of Clinical Oncology Annual Meeting, showed an overall response rate of 36% (n=36) (95% CI, 26.6-46.2), with 1% of patients having a complete response and 35% of patients having a partial response.
In the CRL, the FDA stated that the data from KEYNOTE-524/Study 116 did not demonstrate a meaningful advantage over available therapies for unresectable or metastatic HCC with no prior systemic therapy for advanced disease. In response to the letter, a phase 3 trial, LEAP-002, has been initiated to assess the combination for first-line treatment of advanced HCC.
The FDA previously granted Breakthrough Therapy designation to Keytruda plus Lenvima for HCC.