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NCCN Research Program to Support Studies of Taiho's Futibatinib in Molecularly Defined Tumors

NEW YORK – The National Comprehensive Cancer Network's Oncology Research Program announced today that its experts will provide study oversight for four clinical trials involving Taiho Oncology's futibatinib.

Futibatinib is an inhibitor of FGFR1, FGFR2, FGFR3, and FGFR4 and has previously demonstrated preliminary antitumor activity in a Phase I dose-escalation trial. In the four studies selected by the NCCN's ORP, the drug is being evaluated in a variety of molecularly defined patient populations. 

The studies were selected by a scientific review committee involving oncologists from NCCN member institutions. These studies will now receive oversight support from NCCN, while Taiho will provide futibatinib and fund the studies. Martin Birkhofer, senior VP of Taiho, said in a statement that this provides the company an opportunity to further explore the full potential of futibatinib in a variety of solid tumors while expanding collaborations with key investigators.

In the Phase IB study, futibatinib will be investigated in combination with olaparib (AstraZeneca/Merck's Lynparza) in patients with BRCA1/2-altered solid tumors at the MD Anderson Cancer Center.

A Phase II study will evaluate futibatinib in combination with the anti-PD1 drug pembrolizumab (Merck's Keytruda) in patients with microsatellite stable endometrial carcinoma, also at MD Anderson, while another Phase II study will combine futibatinib with pembrolizumab as a second-line treatment for patients with FGF19-expressing hepatocellular carcinoma at the Mayo Clinic.

In addition, a preclinical research project at the Ohio State University Comprehensive Cancer Center will explore futibatinib as a monotherapy and in combination with other treatments in tumors with novel FGFR alterations.

"There have been some recent discoveries on how FGFR aberrations can impact tumor progression and survival in patients with different cancers, with endometrial cancer being one example," NCCN CMO Wui-Jin Koh said in a statement. "The selected studies offer unique and critical opportunities to learn more about which patients will receive the most benefit from FGFR inhibitors and which approaches are likely to lead to the best outcomes."