Taiho Oncology Announces Presentation of Data for Futibatinib in Advanced Intrahepatic Cholangiocarcinoma at 2020 ASCO Meeting

• Published Month : Monday, 01 Jun 2020 11:00 am

"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 disease with limited treatments, this drug could be an effective and well-tolerated option for patients and the oncologists that care for them."

Taiho Oncology, Inc. has announced efficacy and safety results of an interim analysis of FOENIX-CCA2, a single-arm multicenter Phase 2 study evaluating futibatinib (TAS-120) in patients with intrahepatic cholangiocarcinoma (iCCA) harboring FGFR2 gene fusions or other rearrangements, who have failed at least one line of therapy. The data were presented online at the 2020 American Society of Clinical Oncology (ASCO) Annual Meeting from 10:30 a.m.-12:00 p.m. ET on Sunday, May 31, 2020.

"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 disease with limited treatments, this drug could be an effective and well-tolerated option for patients and the oncologists that care for them."

In the FOENIX-CCA2 trial, 103 patients with locally advanced or metastatic unresectable iCCA harboring FGFR2 gene rearrangements including fusions who had received one or more prior lines of systemic therapy received futibatinib 20 mg once daily until disease progression or unacceptable toxicity. The primary endpoint of the trial is independent central radiology reviewed objective response rate (ORR). Secondary endpoints include disease control rate (DCR), duration of response (DOR) and safety. The interim analysis reported data for 67 patients (65%) with a minimum of 6 months of follow up and found the ORR was 37.3% (1 CR=1.5%; 24 PR=35.8%). Median duration of response was 8.31 months. The most common treatment-related adverse events (all grades, grade 3) at the time of analysis were hyperphosphatemia (80.6%; 26.9%), diarrhea (37.3%; 0%), and dry mouth (32.8%; 0%). There were no grade 4 treatment related adverse events. Final results from the trial will be presented at a future medical meeting.

"FOENIX-CCA2 adds to the body of evidence supporting futibatinib as a potential treatment option for patients living with intrahepatic cholangiocarcinoma," said Martin J. Birkhofer, MD, Senior Vice President and Chief Medical Officer, Taiho Oncology, Inc. "We are pleased to see the interim results of the FOENIX-CCA2 trial, which point to the efficacy and tolerability of futibatinib in these patients, and we look forward to sharing the final results and progressing this investigational compound."

In May 2018, the U.S. Food and Drug Administration Office of Orphan Drug Development granted futibatinib orphan drug status for the treatment of cholangiocarcinoma.