Celcuity Updates VIKTORIA-1 Breast Cancer Results at ESMO 2026
Celcuity presented updated Phase 3 VIKTORIA-1 data for gedatolisib in PIK3CA-mutant advanced breast cancer at ESMO 2026. In patients without liver metastases, median progression-free survival was 21.5 months for the triplet and 11.5 months for the doublet, compared with 9.1 months for alpelisib plus fulvestrant. Response rates in evaluable mutant-cohort patients were 59%, 43%, and 33%, while adverse-event discontinuation rates were lower for the gedatolisib regimens than for the alpelisib comparator.
Celcuity reported updated VIKTORIA-1 findings at ESMO 2026 for gedatolisib in PIK3CA-mutant HR+/HER2- advanced breast cancer. The triplet paired gedatolisib with fulvestrant and palbociclib; the doublet omitted palbociclib. In patients lacking liver metastases, median progression-free survival was 21.5 months for the triplet, 11.5 for the doublet, and 9.1 for alpelisib plus fulvestrant.
Among evaluable mutant-cohort patients, response rates were 59%, 43%, and 33%, with median response durations of 19.4, 27.8, and 7.5 months. Adverse-event discontinuations were 5% and 4% for gedatolisib regimens versus 19% for alpelisib. The doublet’s no-liver-metastases comparison had p=0.1627, so that subgroup result did not establish statistical significance.
Updated breast cancer trial data could matter to patients with PIK3CA-mutant HR+/HER2- advanced disease, their caregivers, and clinicians weighing treatment options. Longer progression-free survival and response duration may inform discussions about gedatolisib-based regimens, while lower adverse-event discontinuation rates could affect tolerability and treatment continuity. Because some subgroup comparisons were not statistically significant, observers may treat the findings as promising but not definitive, and any practical impact would depend on regulatory review, access, and clinical judgment.