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Relay Therapeutics Announces Full Dose Escalation Data for RLY-4008
Data from FGFRi-naïve FGFR2-fusion CCA patients represent subset of September 2022 presentation and remain consistent with previously reported results
About this update from Relay Therapeutics, Inc.
[{"type":"text","content":"Data from FGFRi-naïve FGFR2-fusion CCA patients represent subset of September 2022 presentation and remain consistent with previously reported results\nCAMBRIDGE, Mass., May 25, 2023 (GLOBE NEWSWIRE) -- Relay Therapeutics, Inc. (Nasdaq: RLAY), a clinical-stage precision medicine company transforming the drug discovery process by combining leading-edge computational and experimental technologies, today announced complete first-in-human dose escalation data for RLY-4008, an investigational, potent, selective and oral small molecule inhibitor of fibroblast growth factor receptor 2 (FGFR2). These data, from the global Phase 1/2 ReFocus study in patients with FGFR2-altered cholangiocarcinoma (CCA) and multiple other solid tumors, will be presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting on June 4, 2023. The data being presented at ASCO are generally consistent with those previously reported at the European Society for Medical Oncology (ESMO) Congress in September 2022. Key Data to be Presented at 2023 ASCO Annual Meeting The data that will be presented at the ASCO Annual Meeting are from the dose escalation portion of the ReFocus study, with a cut-off date of January 30, 2023. The dose escalation portion of the study enrolled 116 patients with advanced, FGFR2-altered solid tumors, the majority of whom have CCA (n=91), and investigated 15 doses, ranging from 20mg to 100mg, across three dose schedules – once daily (QD), once daily intermittent and twice daily. The ongoing dose expansion portion of the study includes pivotal and pivotal-supportive cohorts in CCA patients as well as three tumor-agnostic cohorts in patients with other tumor types (non-CCA). Data from the three non-CCA dose expansion cohorts will be presented in the second half of 2023. Among the 91 CCA patients in the dose escalation portion of the study, 25 had FGFR2 fusions and had not previously received an FGFR inhibitor (FGFRi-naïve FGFR2-fusion CCA). This represents a subset of the interim data reported at ESMO in September 2022, which also included some patients from the ongoing dose expansion cohorts. Eleven of these patients were treated at or above the pivotal dose of 70mg QD All 11 patients experienced radiographic tumor reductionsEight of the 11 patients (including all 4 patients receiving the pivotal dose) had a partial respons...