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NCCN 2023: Phase II Trial of Futibatinib/Pembrolizumab in Subgroup With Hepatocellular Carcinoma

By: Celeste L. Dixon
Posted: Friday, April 7, 2023

An ongoing, single-arm phase II study will assess the benefit and safety of using a pan-FGFR inhibitor, futibatinib, in combination with the immune checkpoint inhibitor pembrolizumab in the second-line treatment of patients with FGF19-expressing advanced or metastatic hepatocellular carcinoma. Up to 25% of such patients express the FGF19 gene, explained Nguyen H. Tran, MD, of the Mayo Clinic, Rochester, Minnesota, and colleagues in their poster presented at the NCCN 2023 Annual Conference.

The trial’s primary endpoint is progression-free survival at 6 months, and secondary endpoints include overall survival, quality of life, and adverse events. Patients will receive pembrolizumab intravenously on day 1 of every 21-day cycle and take futibatinib orally every day.

The currently accruing study, called MC200402 ( identifier NCT04828486), is designed to have between 22 and 25 patients. “With 22 evaluable patients, we have 80% power to detect an improvement in 6-month progression-free survival from 25% (historical control) to 47%, assuming a one-sided significance level of 0.1,” explained the researchers. “Response will be assessed radiographically every 9 weeks.”

No randomized clinical trial data are currently available to guide therapy in patients whose disease has progressed after first-line treatment of atezolizumab/bevacizumab or tremelimumab/durvalumab. The estimated primary completion date for this trial is May 2023, with the estimated full study completion date being May 2024.

Disclosure: Dr. Tran reported no conflicts of interest.

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