Relay Therapeutics Reports Strong Phase 1/2 Zovegalisib Data, Validating Phase 3 Dose in Breast Cancer

summarizeSummary

Relay Therapeutics announced positive Phase 1/2 clinical trial data for its lead drug candidate, zovegalisib, in metastatic breast cancer, supporting the ongoing Phase 3 trial.

check_boxKey Events

• Positive Phase 1/2 Zovegalisib Data

  Relay Therapeutics announced encouraging Phase 1/2 ReDiscover trial data for zovegalisib in combination with fulvestrant at the recommended Phase 3 dose.

• Strong Efficacy in Heavily Pre-treated Patients

  The trial showed a median progression-free survival (PFS) of 11.1 months and an objective response rate (ORR) of 43% (52% in second-line patients) in heavily pre-treated patients with PI3Kα-mutated, HR+/HER2- metastatic breast cancer.

• Favorable Tolerability Profile

  The 400mg BID fed dose was generally well tolerated, with a safety profile consistent with previously disclosed data and primarily low-grade, manageable adverse events.

• Validation of Phase 3 Dose

  The data supports the selection of the 400mg BID fed regimen for the ongoing pivotal Phase 3 ReDiscover-2 trial, reinforcing confidence in the drug's development.

auto_awesomeAnalysis

Relay Therapeutics announced positive Phase 1/2 data for zovegalisib, its lead drug candidate, in PI3Kα-mutated, HR+/HER2- metastatic breast cancer. The reported median progression-free survival (PFS) of 11.1 months and objective response rate (ORR) of 43% (52% in second-line patients) are significant for a heavily pre-treated patient population. The favorable tolerability profile, consistent with previous data, further de-risks the program. This data validates the 400mg BID fed dose currently being used in the ongoing pivotal Phase 3 ReDiscover-2 trial, reinforcing confidence in the drug's potential and its Breakthrough Therapy Designation.