On September 12, 2022 Foundation Medicine, Inc., a pioneer in molecular profiling for cancer, and Relay Therapeutics (Nasdaq: RLAY), a clinical-stage precision medicine company transforming the drug discovery process by combining leading-edge computational and experimental technologies, reported a collaboration to develop FoundationOneCDx as a companion diagnostic for RLY-4008, the company’s investigational FGFR2 inhibitor (Press release, Foundation Medicine, SEP 12, 2022, View Source [SID1234619449]).
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RLY-4008 is a selective oral small molecule inhibitor of FGFR2, which is currently being evaluated for use in patients with FGFR2-mutated cholangiocarcinoma (CCA), or bile duct cancer, and other solid tumors. FGFR2 is one of four members of the FGFR family, a set of closely related proteins with highly similar protein sequences and properties. If the therapy and companion diagnostic are approved, FoundationOne CDx would be used to identify patients with FGFR2 fusions and select rearrangements in CCA who may be appropriate for treatment with RLY-4008.
Yesterday, at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) 2022 Congress, Relay presented interim clinical data for RLY-4008 from this patient population in pan-FGFR inhibitor naïve patients demonstrating an 88% overall response rate and anticipates fully enrolling this pivotal cohort in the second half of 2023.
"FGFR2-mutated cholangiocarcinoma is an aggressive condition that’s generally diagnosed in advanced stages when prognosis is poor and treatment options are limited," said Don Bergstrom, M.D., Ph.D., President of R&D at Relay Therapeutics. "We’re proud to partner with the leader in companion diagnostic approvals as we work to advance this potentially life-changing therapy and create access to it once approved."
Foundation Medicine’s portfolio of FDA-approved comprehensive genomic profiling tests offers physicians both blood- and tissue-based testing options for detecting genomic alterations that help guide personalized treatment decisions. As companion diagnostics, FoundationOne CDx and FoundationOneLiquid CDx allow oncologists to identify patients who may be appropriate for FDA-approved targeted therapies.
"Relay Therapeutics is an innovator in precision therapy development who shares our commitment to bringing more effective treatment options to patients, as expeditiously as possible," said Sanket Agrawal, Chief Biopharma Business Officer at Foundation Medicine. "We’re proud to join forces with them as they advance their novel approach to therapy development, and work to increase treatment options for patients living with cholangiocarcinoma."
The oral presentation from the ESMO (Free ESMO Whitepaper) Congress for RLY-4008 is available on the Relay Therapeutics website under Publications: View Source