Relay Therapeutics reports zovegalisib + fulvestrant Phase 1/2 data: 11.1 mo median PFS at RP3D

Relay Therapeutics, Inc.

Median PFS of 11.1 months (95% CI 7.3-13.0) in 57 evaluable PI3Kα-mutated HR+/HER2- mBC patients.
Confirmed ORR 43% overall (15/35) and 52% in second-line patients (11/21).
Safety consistent with prior 600mg fasted; only 4 of 60 patients discontinued due to TRAEs.
Pharmacokinetics of 400mg BID fed comparable to 600mg BID fasted; most patients above IC80.
FDA Breakthrough Therapy designation already granted; Phase 3 ReDiscover-2 trial ongoing since mid-2025.

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