Celcuity Reports VIKTORIA-1 Update: Gedatolisib Triplet Median PFS of 21.5 Months in Breast Cancer Patients Without Liver Metastases
MINNEAPOLIS — Celcuity Inc. (Nasdaq: CELC) on October 24 presented new subgroup analyses from Study 2 of the Phase 3 VIKTORIA-1 trial at the European Society for Medical Oncology (ESMO) Congress 2026. In patients with HR-positive, HER2-negative advanced breast cancer carrying a PIK3CA mutation who had no liver metastases, the gedatolisib triplet (gedatolisib plus fulvestrant and palbociclib) produced a median progression-free survival of 21.5 months, versus 9.1 months for alpelisib plus fulvestrant, a hazard ratio of 0.46 (p=0.0016).
The data were presented by Dr. Barbara Pistilli, head of the Breast Cancer Unit at Gustave Roussy, in a late-breaking rapid oral presentation (LBA 16). Among patients with liver metastases, median progression-free survival was 9.1 months on the triplet versus 4.6 months on the control regimen (hazard ratio 0.47, p<0.0001); among patients with visceral metastases it was 9.8 versus 5.6 months (hazard ratio 0.52). In evaluable patients in the PIK3CA-mutant cohort, the triplet's objective response rate was 59 percent with a median duration of response of 19.4 months, versus 33 percent and 7.5 months for the control.
On safety, discontinuation of gedatolisib due to treatment-emergent adverse events in the mutant cohort was 5 percent for the triplet and 4 percent for the doublet, compared with 19 percent for alpelisib. The company said grade 3 stomatitis with gedatolisib was transient, falling below 3 percent by the second treatment cycle, and discontinuations due to stomatitis were 1 percent and 0 percent for the triplet and doublet.
"The additional data from Study 2 of VIKTORIA-1 show consistent and significant clinical benefit for important sub-groups of breast cancer patients treated with gedatolisib regimens," said Igor Gorbachevsky, Celcuity's chief medical officer, noting that patients without liver metastases represent approximately 60 to 70 percent of all patients treated in this setting. He said the triplet's median duration of response of over 19 months in both VIKTORIA-1 cohorts was, to the company's knowledge, the longest ever reported in the primary analysis of a Phase 3 trial in second-line HR+/HER2- advanced breast cancer.
Gedatolisib, marketed as REVTORPYK, is a pan-PI3K and mTORC1/2 inhibitor approved by the U.S. Food and Drug Administration (FDA) for patients in whom no PIK3CA mutation was detected, following progression on or after endocrine therapy in the metastatic setting; the new results concern the separate PIK3CA-mutant cohort. HR+/HER2- is the most common breast cancer subtype, accounting for about 70 percent of cases. Celcuity, headquartered in Minneapolis, is also running the Phase 3 VIKTORIA-2 trial of gedatolisib regimens as first-line treatment for advanced disease.
Source: GSM · USA (original Chinese edition)
Photo: 图：实验室研究人员进行样本处理（资料图）。照片：美国疾控中心（CDC），公共领域，经 Wikimedia Commons。 / Photo: A researcher at work in a laboratory (file photo). Photo by the U.S. Centers for Disease Control and Prevention, public domain, via Wikimedia Commons.
