Celcuity reports phase 3 win for gedatolisib in PIK3CA-mutant breast cancer

Celcuity said its phase 3 VIKTORIA-1 trial met its primary endpoint in the PIK3CA-mutant cohort, with gedatolisib plus fulvestrant and palbociclib showing a statistically significant, clinically meaningful progression-free survival benefit versus alpelisib plus fulvestrant in people with HR-positive, HER2-negative advanced breast cancer whose disease progressed on or after a CDK4/6 inhibitor and an aromatase inhibitor. The company also said a gedatolisib-plus-fulvestrant doublet beat alpelisib plus fulvestrant on progression-free survival, though that comparison sat outside the trial’s hierarchical primary analysis. Full results are slated for a late-breaking oral presentation at the ASCO Annual Meeting, May 29 to June 2, 2026, in Chicago. (globenewswire.com)

Why it matters: For oncology teams, the readout suggests gedatolisib could emerge as a new competitor in the post-CDK4/6, PIK3CA-mutant setting, where treatment sequencing is already shifting. The current FDA-approved targeted option in this biomarker-defined population is Roche’s inavolisib, approved in October 2024 with palbociclib and fulvestrant for endocrine-resistant HR-positive, HER2-negative advanced breast cancer with a PIK3CA mutation, alongside a companion diagnostic. Celcuity is also already under FDA Priority Review for a separate gedatolisib application in the PIK3CA wild-type population, with a PDUFA date of July 17, 2026, underscoring how quickly the drug could move across adjacent breast cancer subgroups if regulators are persuaded by the full dataset. (fda.gov)

What to watch: The key next step is the ASCO presentation, where clinicians will look for the actual hazard ratios, median progression-free survival, safety tradeoffs, and whether gedatolisib appears differentiated enough from established PI3K-pathway options to change practice. (globenewswire.com)