{"id":897330,"date":"2025-10-18T04:33:16","date_gmt":"2025-10-18T08:33:16","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/celcuity-provides-update-on-status-of-the-pik3ca-mutated-cohort-of-phase-3-viktoria-1-trial-and-releases-additional-data-analysis-from-phase-1b-clinical-trial\/"},"modified":"2025-10-18T04:33:16","modified_gmt":"2025-10-18T08:33:16","slug":"celcuity-provides-update-on-status-of-the-pik3ca-mutated-cohort-of-phase-3-viktoria-1-trial-and-releases-additional-data-analysis-from-phase-1b-clinical-trial","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/celcuity-provides-update-on-status-of-the-pik3ca-mutated-cohort-of-phase-3-viktoria-1-trial-and-releases-additional-data-analysis-from-phase-1b-clinical-trial\/","title":{"rendered":"Celcuity Provides Update on Status of the PIK3CA Mutated Cohort of Phase 3 VIKTORIA-1 Trial and Releases Additional Data Analysis From Phase 1b Clinical Trial"},"content":{"rendered":"<div class=\"mw_release\">\n<ul>\n<li>\n          <em>PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 clinical trial is fully enrolled<\/em><br \/>\n          \n        <\/li>\n<li>\n          <em>Additional analysis of data from a Phase 1b clinical trial that included all patients treated with gedatolisib combined with fulvestrant and palbociclib showed median progression-free survival (\u201cPFS\u201d) of 14.6 months in patients with HR+\/HER2-\/PIK3CA-mutated advanced breast cancer (\u201cABC\u201d)<\/em><br \/>\n          \n        <\/li>\n<\/ul>\n<p>MINNEAPOLIS, Oct.  18, 2025  (GLOBE NEWSWIRE) &#8212; Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced updates on the status of the <em>PIK3CA<\/em> mutant cohort of the Phase 3 VIKTORIA-1 clinical trial evaluating gedatolisib plus fulvestrant with and without palbociclib versus alpelisib and fulvestrant in adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, <em>PIK3CA<\/em> mutant (\u201cMT\u201d) tumors, locally advanced or metastatic breast cancer, following progression on, or after, treatment with a CDK4\/6 inhibitor and an aromatase inhibitor. Analysis of data from a Phase 1b clinical trial that evaluated gedatolisib combined with palbociclib and fulvestrant in the same population was also provided.<\/p>\n<p>\u201cWe are pleased to announce that the <em>PIK3CA<\/em> mutant cohort of the VIKTORIA-1 study is 100% enrolled,\u201d said Brian Sullivan, CEO and co-founder of Celcuity. \u201cBased on our current forecast of reaching the event threshold that will trigger primary analysis in the <em>PIK3CA<\/em> mutant cohort, we expect to report topline data sometime in late Q1 2026 or during Q2 2026.\u201d<\/p>\n<p>\n        <strong>Updated Analysis of Data from the Phase 1b Trial<\/strong>\n      <\/p>\n<p>In a presentation of results from the <em>PIK3CA<\/em> wild-type (\u201cWT\u201d) cohort of the VIKTORIA-1 study at the European Society for Medical Oncology (\u201cESMO\u201d) Congress, additional data from a Phase 1b clinical trial that evaluated gedatolisib in patients with HR+\/HER2- ABC was included. The analyses reported efficacy data from patients who were treated with the same drug regimen evaluated in the VIKTORIA-1 study, gedatolisib combined with fulvestrant and palbociclib.<sup>1<\/sup> This included patients from Escalation Arm B and Expansion Arms B, C and D of the Phase 1b study.<\/p>\n<p>Patients in Escalation Arm B and Expansion Arms B and C received a 180 mg dose of gedatolisib once weekly (\u201cweekly dose\u201d). Patients in Expansion Arm D received a 180 mg dose of gedatolisib on days 1, 8, and 15 of a four-week cycle (\u201cintermittent dose\u201d), which was the same dose regimen patients in the VIKTORIA-1 study received. The proportion of patients who received the intermittent dose of gedatolisib was 37% for those with<em> PIK3CA<\/em> MT tumors and 25% for those with <em>PIK3CA<\/em> WT tumors. The proportion of patients who received prior treatment with a CDK4\/6 inhibitor was 73% for those with <em>PIK3CA<\/em> WT tumors, and 71% for those with <em>PIK3CA<\/em> MT tumors.<\/p>\n<p>Median PFS and the objective response rate (\u201cORR\u201d) were assessed in sub-groups of patients according to their <em>PIK3CA<\/em> status (Table 1). For all analyzed patients with <em>PIK3CA<\/em> MT tumors (n=30), median PFS was 14.6 months and the ORR in response evaluable patients was 48%. Median PFS was 19.7 months and the ORR was 64% in patients with <em>PIK3CA<\/em> MT tumors who received the intermittent dose of gedatolisib used in the VIKTORIA-1 study. For patients with <em>PIK3CA<\/em> WT tumors (n=60), median PFS was 9.0 months and the ORR in response evaluable patients was 41%. Median PFS was 9.1 months and the ORR was 53% in patients with <em>PIK3CA<\/em> WT tumors who received the intermittent dose of gedatolisib used in the VIKTORIA-1 study.<\/p>\n<p>\n        <strong>Table 1: Efficacy Analysis of Phase 1b Patients Treated with Gedatolisib Plus Palbociclib Plus Fulvestrant<\/strong>\n      <\/p>\n<table align=\"center\" style=\"border-collapse: collapse;width:80%;border-collapse:collapse\">\n<tr>\n<td style=\"vertical-align: middle\">\u00a0<\/td>\n<td colspan=\"2\" style=\"border-top: solid black 1pt;border-right: solid black 1pt;border-bottom: solid black 1pt;border-left: solid black 1pt;text-align: center;vertical-align: middle;vertical-align: middle\">\n            <strong><br \/>\n              <em>PIK3CA<\/em><br \/>\n            <\/strong><br \/>\n            <strong> MT<\/strong>\n          <\/td>\n<td colspan=\"2\" style=\"border-top: solid black 1pt;border-right: solid black 1pt;border-bottom: solid black 1pt;text-align: center;vertical-align: middle;vertical-align: middle\">\n            <strong><br \/>\n              <em>PIK3CA<\/em><br \/>\n            <\/strong><br \/>\n            <strong> WT<\/strong>\n          <\/td>\n<\/tr>\n<tr>\n<td style=\"max-width:44%;width:44%;min-width:44%;text-align: center;vertical-align: middle;vertical-align: middle\">\u00a0<\/td>\n<td style=\"max-width:14%;width:14%;min-width:14%;border-bottom: solid black 1pt;border-left: solid black 1pt;text-align: center;vertical-align: middle;vertical-align: middle\">\n            <strong>All<\/strong>\n          <\/td>\n<td style=\"max-width:14%;width:14%;min-width:14%;border-right: solid black 1pt;border-bottom: solid black 1pt;text-align: center;vertical-align: middle;vertical-align: middle\">\n            <strong>Intermittent <br \/>Dose<\/strong>\n          <\/td>\n<td style=\"max-width:14%;width:14%;min-width:14%;border-bottom: solid black 1pt;text-align: center;vertical-align: middle;vertical-align: middle\">\n            <strong>All<\/strong>\n          <\/td>\n<td style=\"max-width:14%;width:14%;min-width:14%;border-right: solid black 1pt;border-bottom: solid black 1pt;text-align: center;vertical-align: middle;vertical-align: middle\">\n            <strong>Intermittent <br \/>dose<\/strong>\n          <\/td>\n<\/tr>\n<tr>\n<td style=\"border-top: solid black 1pt;border-right: solid black 1pt;border-left: solid black 1pt;vertical-align: middle;text-align: left;padding-left: 10.0px;vertical-align: middle\">\n            <strong>N<\/strong>\n          <\/td>\n<td style=\"padding-right: 0;border-right: solid black 1pt;text-align: center;vertical-align: middle;vertical-align: middle\">30<\/td>\n<td style=\"padding-right: 0;border-right: solid black 1pt;text-align: center;vertical-align: middle;vertical-align: middle\">11<\/td>\n<td style=\"padding-right: 0;border-right: solid black 1pt;text-align: center;vertical-align: middle;vertical-align: middle\">60<\/td>\n<td style=\"padding-right: 0;border-right: solid black 1pt;text-align: center;vertical-align: middle;vertical-align: middle\">15<\/td>\n<\/tr>\n<tr>\n<td style=\"border-right: solid black 1pt;border-left: solid black 1pt;vertical-align: middle;text-align: left;padding-left: 10.0px;vertical-align: middle\">\n            <strong>Median PFS (months)<\/strong>\n          <\/td>\n<td style=\"padding-right: 0;border-right: solid black 1pt;text-align: center;vertical-align: middle;vertical-align: middle\">14.6<\/td>\n<td style=\"padding-right: 0;border-right: solid black 1pt;text-align: center;vertical-align: middle;vertical-align: middle\">19.7<\/td>\n<td style=\"padding-right: 0;border-right: solid black 1pt;text-align: center;vertical-align: middle;vertical-align: middle\">9.0<\/td>\n<td style=\"padding-right: 0;border-right: solid black 1pt;text-align: center;vertical-align: middle;vertical-align: middle\">9.1<\/td>\n<\/tr>\n<tr>\n<td style=\"border-right: solid black 1pt;border-bottom: solid black 1pt;border-left: solid black 1pt;vertical-align: middle;text-align: left;padding-left: 10.0px;vertical-align: middle\">\n            <strong>ORR<\/strong>\n          <\/td>\n<td style=\"border-bottom: solid black 1pt;padding-right: 0;border-right: solid black 1pt;text-align: center;vertical-align: middle;vertical-align: middle\">48%<\/td>\n<td style=\"border-bottom: solid black 1pt;padding-right: 0;border-right: solid black 1pt;text-align: center;vertical-align: middle;vertical-align: middle\">64%<\/td>\n<td style=\"border-bottom: solid black 1pt;padding-right: 0;border-right: solid black 1pt;text-align: center;vertical-align: middle;vertical-align: middle\">41%<\/td>\n<td style=\"border-bottom: solid black 1pt;padding-right: 0;border-right: solid black 1pt;text-align: center;vertical-align: middle;vertical-align: middle\">53%<\/td>\n<\/tr>\n<tr>\n<td>\u00a0<\/td>\n<td>\u00a0<\/td>\n<td>\u00a0<\/td>\n<td>\u00a0<\/td>\n<td>\u00a0<\/td>\n<\/tr>\n<\/table>\n<p>\u201cWe are very encouraged by the median PFS of 14.6 months found in the entire <em>PIK3CA<\/em> mutant patient subgroup,\u201d said Igor Gorbatchevsky, MD, Chief Medical Officer of Celcuity. \u201cWhile the sample size is small, the median PFS from patients whose tumors had <em>PIK3CA<\/em> mutations and who received the Phase 3 intermittent gedatolisib dose is promising and consistent with the results from the overall group. We are looking forward to reporting Phase 3 data for this patient subgroup in 2026.\u201d<\/p>\n<p>\n        <strong>About Celcuity<\/strong>\n      <\/p>\n<p>Celcuity is a clinical-stage biotechnology company pursuing development of targeted therapies for treatment of multiple solid tumor indications. The company&#8217;s lead therapeutic candidate is gedatolisib, a potent, pan-PI3K and mTORC1\/2 inhibitor that comprehensively blockades the PAM pathway. Its mechanism of action and pharmacokinetic properties are differentiated from other currently approved and investigational therapies that target PI3K\u03b1, AKT, or mTORC1 alone or together. A Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib in combination with fulvestrant with or without palbociclib in patients with HR+\/HER2- ABC has completed enrollment and reported topline data for the <em>PIK3CA<\/em> WT cohort and has completed enrollment of patients for the <em>PIK3CA <\/em>mutant cohort. \u00a0A Phase 3 clinical trial, VIKTORIA-2, evaluating gedatolisib plus a CDK4\/6 inhibitor and fulvestrant as first-line treatment for patients with HR+\/HER2- ABC is currently enrolling patients. A Phase 1\/2 clinical trial, CELC-G-201, evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer, is ongoing. More detailed information about Celcuity\u2019s active clinical trials can be found at\u00a0<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=GrnM13bEhtMeIBRqlZ67KXxjNPY_yoazpJvPwdcfp6LubV-lpjED5jPHmGroy2COj8D12vevlc9AbPQhS-nHZQu4oRGVqyrAVfEjJxtTyBLACR9YRyuOFCg3T6s7ydAE\" rel=\"nofollow\" target=\"_blank\"><u>ClinicalTrials.gov<\/u><\/a>\u00a0. Celcuity is headquartered in Minneapolis.\u00a0Further information about Celcuity can be found at\u00a0<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=oGcrtya8PAcWsDv7CuaU2DBTFaUHabdYpXQsejktM475W5qd4A0wPM2smnGgZF1qHXceBKsbu1bkBFgxrrlyJdDJuXndd8Ctez0JeXweT-E=\" rel=\"nofollow\" target=\"_blank\"><u>www.celcuity.com<\/u><\/a> . Follow us on\u00a0<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=3aKn3FmGIiNF_osLdby3WzUk0ER94WxvLQC7I_XbmoHa625DpIh0-MsCBxcML8QrqeCjK7pDobvV5GXB5axoOMZetWqf9GNsIibEwQsavWs=\" rel=\"nofollow\" target=\"_blank\"><u>LinkedIn<\/u><\/a> and\u00a0<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=FhM2_8MywZZH1zWFp1sUWy9x1Fh_dIYnY5fNAa8SSfD7IvSCiuxHW4lm07uugyF66Za3ZZNg8s5C-BJfKF7d9w==\" rel=\"nofollow\" target=\"_blank\"><u>X<\/u><\/a>\u00a0.<\/p>\n<p>\n        <strong>Forward-Looking Statements<\/strong>\n      <\/p>\n<p>This press release contains statements that constitute \u201cforward-looking statements\u201d within the meaning of the Private Securities Litigation Reform Act of 1995 including statements relating to the potential therapeutic benefits of gedatolisib; the size, design and timing of our clinical trials, including the release of topline data; our interpretation of topline clinical trial data; and other expectations with respect to gedatolisib. Words such as, but not limited to, \u201clook forward to,\u201d \u201cbelieve,\u201d \u201cexpect,\u201d \u201canticipate,\u201d \u201cestimate,\u201d \u201cintend,\u201d &#8220;confidence,&#8221; &#8220;encouraged,&#8221; \u201cpotential,\u201d \u201cplan,\u201d \u201ctargets,\u201d \u201clikely,\u201d \u201cmay,\u201d \u201cwill,\u201d \u201cwould,\u201d \u201cshould\u201d and \u201ccould,\u201d and similar expressions or words identify forward-looking statements. The forward-looking statements included in this press release are based on management&#8217;s current expectations and beliefs which are subject to a number of risks, uncertainties and factors, including that our topline results are based on a preliminary analysis of key efficacy and safety data, and such data may change following a more comprehensive review of the data related to the clinical trial; unforeseen delays in our clinical trials; and unanticipated developments that may impact the design of our clinical trials. In addition, all forward-looking statements are subject to other risks detailed in our Annual Report on Form 10-K for the year ended December 31, 2024, as such risks may be updated in our subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by these cautionary statements, and we undertake no obligation to revise or update this press release to reflect events or circumstances after the date hereof.<\/p>\n<p>\n        <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=M4P0TlMWNsjQFYCtcE6EpHJ3z4POuS8lCIUvtn-mOqprR4UQOYBBnSTpgbEtHopAjGs-I5Luz9gRwT-47HMFEAnAwG2Ze3zTHIp8Ms72QrPyalOT6grzriOk3MUfMAOw1OxsvqhPqPQNRLP8B2_MWp-Sh9RU7EPJcRPsBKvI4uG8FPyYIiczoA4FqYCxO6wwcnJonGzflQkHOa0ZmenXgdCjLQGgdFO5NbP95-MSmqd7xvZB3dRIjuDO0qCF8LrNN0YhJQz_DAzjzwIqplXdq8psSvT1_TKLYNR2o7SLYJR6DYv11LC0jhnjvDRcyku4oGxpfz-p3AyrZC0e1tDxO2NayDOR9XL7XQprRdUtQNEVE-_kNrsuIinEKrf7k0bKG0oa5e8wCNV9250qz5qLdwW-yDPxa3orJT32pB7QLpjXKScx0xWpjlEBjHMYWvf3oTTJ_aEMIz1MjXD981sRI20LFrpJk4x98ID_akKyo9apoyhwNiI0c0xFE_F7epHhViXXqp_u1531oILLgeeb040k0y2v8qHOrXyBuhsWV_zOoxEZ2tbhEjiBIsmJXHDn2LnCUPh_Q0P5xCOdGpkIhjho1qcTiiIuld7eHX7HcyhOzusmtEhu97VWUDeg0JmXVTrXT2FumGscrAWmsE3fxHMJbVs-SWNRpwlnqUL4E9G99kmj7EEZJHd_VheBimF-jv1R7f1WJIM-jcCDdE_46xuSlXmDbLZmCTJxo8S4-ghYcUMXfyo6P7B3AoZx4jQ8\" rel=\"nofollow\" target=\"_blank\">View source version of release on GlobeNewswire.com<\/a>\n      <\/p>\n<p>\n        <strong>Reference:<\/strong>\n      <\/p>\n<ol>\n<li>Layman R., Lancet Oncol. 2024;25:474-8<\/li>\n<\/ol>\n<p>\n        <strong>Contacts:<\/strong>\u00a0<\/p>\n<p>Celcuity Inc.\u00a0<br \/>Brian Sullivan, <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=JcUmKqYRRClLvI6fTP_U5NNH2JpW9p8qD0DsWNcl96YN44clnrj5TUBLbuOpSN7YctO4BYSSA0diD-aXr_J5bP7F-lbUiHeKsILrAdtpvxI=\" rel=\"nofollow\" target=\"_blank\">bsullivan@celcuity.com<\/a>\u00a0<br \/>Vicky Hahne, <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=rKQAtsA0_yHk_N6FDy3kC3ypfyRYeaxWEj2L8zI69qSHzNqkmAXWkBDKBPmGaYRBcqMjKSZlxKbWhPH0N5J4e5OV9lufrNso7OHErrtXaGM=\" rel=\"nofollow\" target=\"_blank\">vhahne@celcuity.com<\/a>\u00a0<br \/>(763) 392-0123\u00a0<\/p>\n<p>ICR Healthcare<br \/>Patti Bank, patti.bank@icrhealthcare.com<br \/>(415) 513-1284<\/p>\n<p>      <img decoding=\"async\" alt=\"\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTU0Nzc3MSM3MjAyMTMyIzIxNTcwMDM=\" \/><br \/>\n      <br \/>\n      <img decoding=\"async\" alt=\"\" src=\"https:\/\/ml.globenewswire.com\/media\/ZTY0NmVmM2ItZWI3OC00YzNlLTlhOTAtNjkwNmFjMGM5NmY2LTExNjg1NzMtMjAyNS0xMC0xOC1lbg==\/tiny\/Celcuity-Inc-.png\" \/>\n    <\/div>\n<div class=\"mw_contactinfo\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 clinical trial is fully enrolled Additional analysis of data from a Phase 1b clinical trial that included all patients treated with gedatolisib combined with fulvestrant and palbociclib showed median progression-free survival (\u201cPFS\u201d) of 14.6 months in patients with HR+\/HER2-\/PIK3CA-mutated advanced breast cancer (\u201cABC\u201d) MINNEAPOLIS, Oct. 18, 2025 (GLOBE NEWSWIRE) &#8212; Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced updates on the status of the PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 clinical trial evaluating gedatolisib plus fulvestrant with and without palbociclib versus alpelisib and fulvestrant in adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA mutant (\u201cMT\u201d) tumors, &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/celcuity-provides-update-on-status-of-the-pik3ca-mutated-cohort-of-phase-3-viktoria-1-trial-and-releases-additional-data-analysis-from-phase-1b-clinical-trial\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Celcuity Provides Update on Status of the PIK3CA Mutated Cohort of Phase 3 VIKTORIA-1 Trial and Releases Additional Data Analysis From Phase 1b Clinical Trial&#8221;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-897330","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.9 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Celcuity Provides Update on Status of the PIK3CA Mutated Cohort of Phase 3 VIKTORIA-1 Trial and Releases Additional Data Analysis From Phase 1b Clinical Trial - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/celcuity-provides-update-on-status-of-the-pik3ca-mutated-cohort-of-phase-3-viktoria-1-trial-and-releases-additional-data-analysis-from-phase-1b-clinical-trial\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Celcuity Provides Update on Status of the PIK3CA Mutated Cohort of Phase 3 VIKTORIA-1 Trial and Releases Additional Data Analysis From Phase 1b Clinical Trial - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 clinical trial is fully enrolled Additional analysis of data from a Phase 1b clinical trial that included all patients treated with gedatolisib combined with fulvestrant and palbociclib showed median progression-free survival (\u201cPFS\u201d) of 14.6 months in patients with HR+\/HER2-\/PIK3CA-mutated advanced breast cancer (\u201cABC\u201d) MINNEAPOLIS, Oct. 18, 2025 (GLOBE NEWSWIRE) &#8212; Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced updates on the status of the PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 clinical trial evaluating gedatolisib plus fulvestrant with and without palbociclib versus alpelisib and fulvestrant in adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA mutant (\u201cMT\u201d) tumors, &hellip; Continue reading &quot;Celcuity Provides Update on Status of the PIK3CA Mutated Cohort of Phase 3 VIKTORIA-1 Trial and Releases Additional Data Analysis From Phase 1b Clinical Trial&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/celcuity-provides-update-on-status-of-the-pik3ca-mutated-cohort-of-phase-3-viktoria-1-trial-and-releases-additional-data-analysis-from-phase-1b-clinical-trial\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2025-10-18T08:33:16+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTU0Nzc3MSM3MjAyMTMyIzIxNTcwMDM=\" \/>\n<meta name=\"author\" content=\"Newsdesk\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Newsdesk\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"6 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/celcuity-provides-update-on-status-of-the-pik3ca-mutated-cohort-of-phase-3-viktoria-1-trial-and-releases-additional-data-analysis-from-phase-1b-clinical-trial\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/celcuity-provides-update-on-status-of-the-pik3ca-mutated-cohort-of-phase-3-viktoria-1-trial-and-releases-additional-data-analysis-from-phase-1b-clinical-trial\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"Celcuity Provides Update on Status of the PIK3CA Mutated Cohort of Phase 3 VIKTORIA-1 Trial and Releases Additional Data Analysis From Phase 1b Clinical Trial\",\"datePublished\":\"2025-10-18T08:33:16+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/celcuity-provides-update-on-status-of-the-pik3ca-mutated-cohort-of-phase-3-viktoria-1-trial-and-releases-additional-data-analysis-from-phase-1b-clinical-trial\\\/\"},\"wordCount\":1185,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/celcuity-provides-update-on-status-of-the-pik3ca-mutated-cohort-of-phase-3-viktoria-1-trial-and-releases-additional-data-analysis-from-phase-1b-clinical-trial\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.globenewswire.com\\\/newsroom\\\/ti?nf=OTU0Nzc3MSM3MjAyMTMyIzIxNTcwMDM=\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/celcuity-provides-update-on-status-of-the-pik3ca-mutated-cohort-of-phase-3-viktoria-1-trial-and-releases-additional-data-analysis-from-phase-1b-clinical-trial\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/celcuity-provides-update-on-status-of-the-pik3ca-mutated-cohort-of-phase-3-viktoria-1-trial-and-releases-additional-data-analysis-from-phase-1b-clinical-trial\\\/\",\"name\":\"Celcuity Provides Update on Status of the PIK3CA Mutated Cohort of Phase 3 VIKTORIA-1 Trial and Releases Additional Data Analysis From Phase 1b Clinical Trial - 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Market Newsdesk","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.marketnewsdesk.com\/index.php\/celcuity-provides-update-on-status-of-the-pik3ca-mutated-cohort-of-phase-3-viktoria-1-trial-and-releases-additional-data-analysis-from-phase-1b-clinical-trial\/","og_locale":"en_US","og_type":"article","og_title":"Celcuity Provides Update on Status of the PIK3CA Mutated Cohort of Phase 3 VIKTORIA-1 Trial and Releases Additional Data Analysis From Phase 1b Clinical Trial - Market Newsdesk","og_description":"PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 clinical trial is fully enrolled Additional analysis of data from a Phase 1b clinical trial that included all patients treated with gedatolisib combined with fulvestrant and palbociclib showed median progression-free survival (\u201cPFS\u201d) of 14.6 months in patients with HR+\/HER2-\/PIK3CA-mutated advanced breast cancer (\u201cABC\u201d) MINNEAPOLIS, Oct. 18, 2025 (GLOBE NEWSWIRE) &#8212; Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced updates on the status of the PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 clinical trial evaluating gedatolisib plus fulvestrant with and without palbociclib versus alpelisib and fulvestrant in adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA mutant (\u201cMT\u201d) tumors, &hellip; Continue reading \"Celcuity Provides Update on Status of the PIK3CA Mutated Cohort of Phase 3 VIKTORIA-1 Trial and Releases Additional Data Analysis From Phase 1b Clinical Trial\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/celcuity-provides-update-on-status-of-the-pik3ca-mutated-cohort-of-phase-3-viktoria-1-trial-and-releases-additional-data-analysis-from-phase-1b-clinical-trial\/","og_site_name":"Market Newsdesk","article_published_time":"2025-10-18T08:33:16+00:00","og_image":[{"url":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTU0Nzc3MSM3MjAyMTMyIzIxNTcwMDM=","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"6 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/celcuity-provides-update-on-status-of-the-pik3ca-mutated-cohort-of-phase-3-viktoria-1-trial-and-releases-additional-data-analysis-from-phase-1b-clinical-trial\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/celcuity-provides-update-on-status-of-the-pik3ca-mutated-cohort-of-phase-3-viktoria-1-trial-and-releases-additional-data-analysis-from-phase-1b-clinical-trial\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"Celcuity Provides Update on Status of the PIK3CA Mutated Cohort of Phase 3 VIKTORIA-1 Trial and Releases Additional Data Analysis From Phase 1b Clinical Trial","datePublished":"2025-10-18T08:33:16+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/celcuity-provides-update-on-status-of-the-pik3ca-mutated-cohort-of-phase-3-viktoria-1-trial-and-releases-additional-data-analysis-from-phase-1b-clinical-trial\/"},"wordCount":1185,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/celcuity-provides-update-on-status-of-the-pik3ca-mutated-cohort-of-phase-3-viktoria-1-trial-and-releases-additional-data-analysis-from-phase-1b-clinical-trial\/#primaryimage"},"thumbnailUrl":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTU0Nzc3MSM3MjAyMTMyIzIxNTcwMDM=","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/celcuity-provides-update-on-status-of-the-pik3ca-mutated-cohort-of-phase-3-viktoria-1-trial-and-releases-additional-data-analysis-from-phase-1b-clinical-trial\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/celcuity-provides-update-on-status-of-the-pik3ca-mutated-cohort-of-phase-3-viktoria-1-trial-and-releases-additional-data-analysis-from-phase-1b-clinical-trial\/","name":"Celcuity Provides Update on Status of the PIK3CA Mutated Cohort of Phase 3 VIKTORIA-1 Trial and Releases Additional Data Analysis From Phase 1b Clinical Trial - 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