Celcuity shares slumped 15% despite Phase 3 VIKTORIA-1 data showing gedatolisib triplet therapy halved progression or death risk versus alpelisib plus fulvestrant, with median PFS of 11.1 months versus 5.6 months. The triplet produced a 48.9% objective response rate and only 2.6% discontinuation for treatment-related adverse events, underscoring tolerability.
The VIKTORIA-1 study enrolled hormone receptor-positive, HER2-negative, PIK3CA-mutant advanced or metastatic breast cancer patients to evaluate gedatolisib in combination with fulvestrant and palbociclib (triplet) and fulvestrant alone (doublet) against alpelisib plus fulvestrant.
Triplet therapy reduced the risk of disease progression or death by 50%, with median progression-free survival of 11.1 months versus 5.6 months for the comparator. The doublet regimen showed a 49% risk reduction and median PFS of 11.3 months, demonstrating consistent benefit across both approaches.
The gedatolisib triplet achieved an objective response rate of 48.9% with a median response duration of 15.7 months, while the doublet delivered a 35.7% response rate and 24.2-month median duration, highlighting sustained clinical benefit in responders.
Both gedatolisib regimens were generally well tolerated, with discontinuation rates of 2.6% for triplet and 3.8% for doublet versus 7.1% for alpelisib plus fulvestrant. Despite these positive findings, shares dropped 15% following the data release.
Investors
Finance
Finviz
