12 of 20 evaluable patients achieved a volumetric response at 12 weeks in Relay Therapeutics’ Phase 2 ReInspire trial, with one later unconfirmed response lifting the rate to 65%.
The 60% response rate far exceeded Leerink’s 20%–25% bar for success and topped Novartis’ 11% week-16 result for Vijoice in a failed PROS study, strengthening Relay’s case for accelerated approval discussions with the FDA.
22 patients had enrolled by April 15, mostly with PIK3CA-related overgrowth spectrum, and Relay said 300 mg twice daily appears to capture the efficacy ceiling while higher doses bring more tolerability challenges.
89% of patients showed investigator-measured clinical improvement and 71% of pain symptoms improved; two of 22 patients had grade 3 or higher treatment-related adverse events, with no dose discontinuations reported.
Relay is opening expansion cohorts at 400 mg once daily and 300 mg twice daily for patients 12 and older, while also running a dose-finding study in children aged six to 11.
Beyond its stunning trial results, can Relay’s drug platform revolutionize how we target other disease-causing proteins in medicine?
As a new PI3Kα drug war begins, can Relay's inhibitor outmaneuver Novartis's multi-billion dollar bet in cancer and rare diseases?
With a 60% response rate, is this the breakthrough vascular malformation patients have been waiting for, or is the hype premature?
Relay Therapeutics’ Zovegalisib Delivers 60% Lesion Reduction in Phase 2 for PIK3CA-Driven Vascular Anomalies
Overview
Relay Therapeutics has announced highly promising Phase 2 results for zovegalisib, a novel treatment designed for PIK3CA-driven vascular anomalies. The pivotal study showed that 60% of response-evaluable adults and adolescents experienced a volumetric lesion response at 12 weeks, highlighting zovegalisib’s strong efficacy. These breakthrough results set a new benchmark in the treatment landscape for these challenging conditions, offering substantial clinical benefit to patients who often have limited options. The high response rate and differentiated safety profile position zovegalisib as a potential new standard for managing PIK3CA-driven vascular anomalies.