Core Insights - Relay Therapeutics announced interim clinical data for zovegalisib, an investigational allosteric, pan-mutant, and isoform-selective inhibitor of PI3Kα, showing promising efficacy in patients with metastatic breast cancer [1][10] Efficacy Data - The median progression-free survival (PFS) was reported as 10.3 months for all patients and 11.4 months for second-line (2L) patients [6] - Among patients with measurable disease, the objective response rate (ORR) was 39%, while the ORR for 2L patients was 47% [6] - Efficacy was consistent across various subsets, with a median PFS of 11.4 months and ORR of 44% for patients who received prior SERD [7] Patient Population - As of October 15, 2025, 118 patients were enrolled in the zovegalisib + fulvestrant arm of the ReDiscover study, with significant prior therapy levels noted [4] - Among the 64 patients receiving 600mg twice daily, 44% had two or more prior lines of therapy, and 29% had detectable ESR1 mutations at baseline [4] Ongoing Trials - The Phase 3 ReDiscover-2 trial is ongoing, focusing on zovegalisib + fulvestrant in PI3Kα-mutated, CDK4/6 pre-treated, HR+/HER2- advanced breast cancer [8] - The ReDiscover trial is also evaluating zovegalisib in combination with fulvestrant and CDK inhibitors [3] Company Overview - Relay Therapeutics is a clinical-stage company focused on developing precision medicine therapies for cancer and genetic diseases, with zovegalisib being its lead program [12] - The company utilizes its Dynamo platform to discover and develop mutant-selective inhibitors of PI3Kα, addressing a significant patient population in the U.S. [10][12]
Relay Therapeutics Announces Efficacy Subset Analysis of Zovegalisib (RLY-2608) + Fulvestrant in Breast Cancer Patients Pre-Treated with SERD or with ESR1 Mutations at SABCS 2025