88% overall response rate (15 out of 17) from interim data of pan-FGFR treatment (FGFRi)-naïve FGFR2-fusion cholangiocarcinoma (CCA) patients treated at the pivotal dose
Enrollment for the pivotal cohort anticipated to be completed in the second half of 2023
Relay Therapeutics to host a conference call on Monday, September 12, at 8:00 am E.T.
CAMBRIDGE, Mass., Sept. 11, 2022 (GLOBE NEWSWIRE) -- Relay Therapeutics, Inc. (Nasdaq: RLAY) today announced late breaking interim clinical data in an oral presentation for RLY-4008, an investigational, potent, selective and oral small molecule inhibitor of fibroblast growth factor receptor 2 (FGFR2), in a global phase 1/2 clinical trial in patients with FGFR2-altered CCA and multiple other solid tumors. The interim data presented today at the European Society for Medical Oncology (ESMO) Congress demonstrate an 88% overall response rate (ORR) at the pivotal dose of RLY-4008, 70 mg once daily (QD), as of August 1, 2022, and further support our hypothesis that selective inhibition of FGFR2 can improve the treatment for patients with FGFR2-driven tumors.
“We are thrilled to be sharing interim RLY-4008 data from patients treated at the pivotal dose with the ESMO community,” said Don Bergstrom, M.D., Ph.D., President of R&D at Relay Therapeutics. “We believe the interim ORR of 88% for these patients helps to demonstrate the potential power of our Dynamo platform to build transformative therapies for patients. Additionally, we continue to generate clinical data outside of CCA and anticipate sharing them in 2023. Beyond RLY-4008, we have a robust pipeline of precision medicine candidates, and we look forward to next presenting initial clinical data on our pan-mutant-selective PI3Kα inhibitor, RLY-2608, expected in the first half of 2023. Thank you to the patients, investigators and clinical trial teams who participate in clinical trials of our investigational therapies.”
Key Data Presented at ESMO Congress 2022
The data presented at the ESMO Congress were based on an August 1, 2022 data cut-off date from both the dose escalation and dose expansion phases of the trial. The interim data included a safety database of 195 patients, with 89 patients treated at the pivotal dose of 70 mg QD, of which 17 were FGFRi-naïve FGFR2-fusion CCA patients eligible for efficacy evaluation (patients with measurable disease who had opportunity for ≥2 tumor assessments to confirm response or discontinued treatment with