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Celcuity's Phase 3 VIKTORIA-1 Trial Achieves Primary Endpoint With Clinically Meaningful Improvement in Progression-Free Survival in PIK3CA Mutant Cohort
Detailed data for the gedatolisib triplet and doublet regimens will be presented at a late-breaking abstract oral session at the 2026 ASCO Annual MeetingMINNEAPOLIS, May 01, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced positive topline results from the PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 clinical trial evaluating gedatolisib plus fulvestrant with or without palboci
About this update from Celcuity Inc.
[{"type":"image","alt":"Celcuity Inc.","displaySize":"","headline":null,"caption":"Celcuity Inc.","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":85,"url":"https://media.zenfs.com/en/globenewswire.com/0f5ff122ae01812e1c96be03e8598b65"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/aT0CeGgbDCIqj5AUGMKkCg--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTExOQ--/https://media.zenfs.com/en/globenewswire.com/0f5ff122ae01812e1c96be03e8598b65","width":300,"height":85}},"lazy":false},{"type":"text","content":"Detailed data for the gedatolisib triplet and doublet regimens will be presented at a late-breaking abstract oral session at the 2026 ASCO Annual Meeting","length":153,"tagName":"p"},{"type":"text","content":"MINNEAPOLIS, May 01, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced positive topline results from the PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 clinical trial evaluating gedatolisib plus fulvestrant with or without palbociclib in patients with hormone receptor positive (“HR+”), human epidermal growth factor receptor 2 negative (“HER2-”), PIK3CA mutant locally advanced or metastatic breast cancer (“ABC”), following progression on or after treatment with a CDK4/6 inhibitor and an aromatase inhibitor. Detailed results will be presented in a late-breaking abstract (“LBA”) oral session at the American Society of Clinical Oncology (“ASCO”) Annual Meeting, taking place May 29 – June 2, 2026, in Chicago, Illinois.","length":845,"tagName":"p"},{"type":"text","content":"The primary efficacy analysis of gedatolisib combined with fulvestrant and palbociclib (the “gedatolisib triplet”) demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (“PFS”) compared to alpelisib, a PI3Kα inhibitor, and fulvestrant. The secondary endpoint comparing gedatolisib plus fulvestrant (the “gedatolisib doublet”) versus alpelisib plus fulvestrant, which was not part of the primary efficacy analysis in the hierarchical order, also demonstrated a statistically significant and clinically meaningful improvement in PFS compared to alpelisib and fulvestrant. Both gedatolisib regimens were generally well tolerated, with manageable safety profiles, and no new safety signals.","length":7...