Initiation of Phase 3 ReDiscover-2 trial of RLY-2608 + fulvestrant anticipated in the middle of 2025 in PI3Kα-mutated, CDK4/6 pre-treated, HR+/HER2- metastatic breast cancer
Presented interim data for RLY-2608 + fulvestrant showing 11.4-month median PFS in 2L patients with PI3Kα-mutated, HR+/HER2- metastatic breast cancer
Continued progression of other front-line breast cancer regimens, including initiation of atirmociclib triplet, and planning for development of future oral endocrine therapy combinations underway
Approximately $780 million in cash, cash equivalents and investments at end of Q4 2024, which will be prioritized to fully fund the execution of the ReDiscover-2 Phase 3 trial
CAMBRIDGE, Mass., Feb. 26, 2025 (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 reported fourth quarter and full year 2024 financial results and corporate highlights.
“Our RLY-2608 breast cancer program continued to advance and develop rapidly in 2024, driven by positive maturation of the RLY-2608 + fulvestrant doublet dataset, now with over 100 patients dosed and median PFS of 11.4 months in second-line patients. We also continue to make progress with our investigational triplet combinations, which we believe could potentially allow RLY-2608 to address patients in earlier settings,” said Sanjiv Patel, M.D., President and Chief Executive Officer of Relay Therapeutics. “Looking forward into 2025, it is our top priority to continue advancing our clinical programs, including the initiation of the RLY-2608 + fulvestrant Phase 3 trial in breast cancer patients. With a strong capital position that supports the execution of that pivotal trial, and a team with proven development experience, I am confident in our abilities to meaningfully advance these programs towards patients in oncology and genetic disease areas.”
Initiation of ReDiscover-2 Phase 3 trial of RLY-2608 + Fulvestrant in the Middle of 2025
- Relay Tx has conducted an end of Phase 2 meeting with the Food and Drug Administration (FDA) and announces the Phase 3 trial design, dose, and plans to initiate the trial in mid-2025
- Design
- Planned Phase 3 registrational study (ReDiscover-2) is a randomized, open-label, multicenter clinical trial that will evaluate the safety and efficacy of RLY-2608 + fulvestrant in PI3Kα-mutated, HR+/HER2- advanced breast cancer patients previously treated with a CDK4/6 inhibitor
- Comparator arm will be capivasertib + fulvestrant
- Key inclusion criteria include:
- Patients must be CDK4/6-experienced (either in the adjuvant or metastatic setting)
- Patients must have been on frontline endocrine therapy containing regimen for >6 months
- Patients may have seen up to 1 prior chemotherapy and no ADC in the metastatic setting
- Metabolic inclusion criteria: HbA1c