Futibatinib shows promise for cholangiocarcinoma in phase 2 study
Positive efficacy and safety results from an interim analysis of Phase 2 study evaluating futibatinib (TAS-120) in patients with intrahepatic cholangiocarcinoma harboring FGFR2 gene fusions or other rearrangements, who have failed at least one line of therapy were presented at the 2020 American Society of Clinical Oncology Virtual Annual Meeting.
In the FOENIX-CCA2 trial, 103 patients received futibatinib 20 mg once daily until disease progression or unacceptable toxicity. The primary endpoint of is independent central radiology reviewed objective response rate and secondary endpoints include disease control rate, duration of response (DOR), and safety.
Data for 67 patients with a at least 6 months of follow up were reported in interim analysis. Objective response rate was 37.3% and median duration of response was 8.31 months.
Common treatment-related adverse events at the time of analysis were hyperphosphatemia, diarrhea, and dry mouth.
“The interim analysis demonstrated that treatment with the covalently-binding FGFR inhibitor futibatinib may lead to meaningful clinical benefit in patients with refractory iCCA with FGFR2 gene fusions or other rearrangements,” said medical oncologist Lipika Goyal, MD, MPhil of the Massachusetts General Hospital Cancer Center, in a press release. “In a disease with limited treatments, this drug could be an effective and well-tolerated option for patients and the oncologists that care for them.”