Celcuity’s Gedatolisib Doubles Survival Benefits in Advanced Breast Cancer Trial
Event summary
- Celcuity’s gedatolisib-triplet regimen reduced the risk of disease progression or death by 50% compared to alpelisib plus fulvestrant in the PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 trial.
- Median progression-free survival (PFS) was 11.1 months with the gedatolisib-triplet versus 5.6 months with alpelisib plus fulvestrant.
- The gedatolisib-doublet regimen reduced the risk of disease progression or death by 49% compared to alpelisib plus fulvestrant, with a median PFS of 11.3 months versus 5.6 months.
- Celcuity plans to submit these data to the FDA as a supplemental New Drug Application (sNDA) following the PDUFA goal date of July 17, 2026.
The big picture
Celcuity’s gedatolisib represents a significant advancement in targeting the PI3K/AKT/mTOR (PAM) pathway, offering a multi-target approach that has demonstrated superior efficacy and safety compared to single-target inhibitors. This development is crucial in the treatment of HR+/HER2- advanced breast cancer, a subtype that accounts for approximately 70% of all breast cancers. The strategic anomaly here is the unprecedented improvement in progression-free survival and objective response rates, positioning gedatolisib as a potential new standard of care if approved.
What we're watching
- Regulatory Approval
- Whether the FDA will grant approval for gedatolisib based on the VIKTORIA-1 trial results, potentially setting a new standard of care for HR+/HER2- advanced breast cancer.
- Market Adoption
- The pace at which gedatolisib could be adopted in the market, given its superior efficacy and safety profile compared to existing treatments.
- Clinical Development
- How the ongoing Phase 3 VIKTORIA-2 trial and other clinical studies will further validate gedatolisib’s potential in different patient populations and treatment settings.
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