Relay’s Zovegalisib Delivers 60% Volumetric Response, 89% Investigator-Reported Improvement
Relay Therapeutics reported a 60% volumetric lesion response at 12 weeks across three zovegalisib dose levels, including 29% at 100mg BID, with 89% investigator-reported and 79% patient-reported symptom improvements. No patients discontinued due to adverse events, and expansion cohorts at 400mg QD and 300mg BID are open.
1. Efficacy Results
In the Phase 2 ReInspire trial Part 1, 32 adults and adolescents received zovegalisib across 100mg BID, 300mg BID, and 400mg BID cohorts. Of 20 response-evaluable patients, 60% achieved at least 20% volumetric reduction by week 12, including 29% response at the lowest dose, while 95% experienced some lesion shrinkage.
2. Clinical Improvement Measures
Investigator global impression assessments showed 89% of patients achieved clinical improvement at week 12, and 79% of patients reported symptom relief on patient global impression scales, indicating meaningful benefit in pain and functional outcomes.
3. Safety and Tolerability
The interim safety profile supported chronic dosing, with no discontinuations due to adverse events across all dose levels. Adverse events were manageable, confirming a potential therapeutic window for long-term use.
4. Expansion Cohorts and Next Steps
Relay Therapeutics has opened expansion cohorts at 400mg once daily and 300mg BID for adults and adolescents, while pediatric dose-finding continues in younger age groups. The company plans further evaluation of efficacy, safety, pharmacokinetics, and pharmacodynamics in these cohorts.