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FDA Grants Breakthrough Therapy Designation to Pembrolizumab Plus Lenvatinib in Advanced HCC

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The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to the programmed cell death protein 1 inhibitor pembrolizumab in combination with the multiple kinase inhibitor lenvatinib for the potential first-line treatment of patients with advanced unresectable hepatocellular carcinoma (HCC) not amenable to locoregional treatment.

The designation is based on updated interim results from the phase Ib KEYNOTE-524/Study 116 trial. An earlier interim analysis was presented at the American Association for Cancer Research (AACR) Annual Meeting 2019 (Abstract CT061/18).

More About KEYNOTE-524/Study 116

KEYNOTE-524/Study 116 is a multicenter, open-label, single-arm phase Ib study evaluating the safety and efficacy of the combination of pembrolizumab (200 mg intravenously every 3 weeks) and lenvatinib (12 mg/day for patients weighing 60 kg or more, and 8 mg/day for patients weighing less than 60 kg) in patients with unresectable HCC classified as Barcelona Clinic Liver Cancer stage B or C, Child-Pugh class A, and ECOG performance status of 0 or 1.

The primary endpoints are tolerability and safety, and the secondary endpoints include overall survival, objective response rate, progression-free survival, and time to progression using modified Response Evaluation Criteria in Solid Tumors (mRECIST) criteria.

Tumor assessments of complete response or partial response were confirmed at least 4 weeks (or longer) after initial response. The first part of the trial evaluated tolerability by assessing dose-limiting toxicities during the first cycle of treatment in patients for whom no other appropriate therapy was available. After tolerability was confirmed, additional patients with no prior systemic therapy for unresectable HCC were enrolled in the expansion part of the trial, which is evaluating objective response rate and duration of response as measured by mRECIST and Response Evaluation Criteria in Solid Tumors (RECIST 1.1) based on independent imaging review.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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