Breast-cancer triplet nearly triples time without progression in key subgroup, ESMO data show
Illustration: Press Pass USAA three-drug regimen built on the breast-cancer drug gedatolisib kept patients' cancer from progressing for a median of 21.5 months — versus 9.1 months on standard therapy — in a key subgroup of patients with PIK3CA-mutant, hormone-receptor-positive, HER2-negative advanced breast cancer, updated phase 3 results presented Saturday at the ESMO Congress in Madrid showed.
The data come from the PIK3CA-mutant cohort of Celcuity's phase 3 VIKTORIA-1 trial, presented by Dr. Barbara Pistilli of Gustave Roussy. Among patients without liver metastases, the gedatolisib triplet (gedatolisib plus fulvestrant and palbociclib) reached a median progression-free survival of 21.5 months, and the two-drug gedatolisib doublet 11.5 months, versus 9.1 months for alpelisib plus fulvestrant. The triplet's advantage carried a hazard ratio of 0.46, and its response rate was 59% versus 33% for the control arm.
The triplet also proved easier to stay on: only 5% of patients stopped gedatolisib because of treatment-related side effects, versus 19% who stopped alpelisib. In patients with liver metastases, median progression-free survival was 9.1 months on the triplet and 11.1 months on the doublet, versus 4.6 months on control — both comparisons statistically significant.
One important caveat: the U.S. approval granted in July 2026 for gedatolisib (sold as Revtorpyk) covers patients without a detected PIK3CA mutation — not this mutant subgroup, for which these results are new subgroup analyses rather than a new approval.
Sources: Celcuity / GlobeNewswire (Oct 24, 2026); NovaPharmaNews (Oct 24, 2026).
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