Relay Therapeutics reports 44% ORR for zovegalisib triplet; plans Phase 3 in frontline breast cancer

Relay Therapeutics, Inc.

ORR of 44% (15/34) in heavily pre-treated, CDK4/6-experienced patients; 85% tumor reduction.
Grade 3 hyperglycemia 0% despite 47% pre-diabetic; only 3% discontinued zovegalisib due to TRAEs.
Phase 3 trial of zovegalisib + atirmociclib + AI in 1L PIK3CA-mutated HR+/HER2- breast cancer expected to start early 2027.
Pfizer to supply atirmociclib and palbociclib for the trial; Relay retains full rights to zovegalisib.
Median follow-up 7.4 months; 77% of patients remain on study; median PFS not yet mature.

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