Celcuity Presents Overall Survival Data from Phase 1b Study Evaluating Gedatolisib in Combination with Palbociclib and Endocrine Therapy at the 2024 San Antonio Breast Cancer Symposium
Celcuity (CELC) announced overall survival (OS) data from a Phase 1b trial evaluating gedatolisib in combination with palbociclib and endocrine therapy for HR+, HER2- advanced breast cancer. The study showed promising results with a median OS of 77.3 months in treatment-naïve patients and 33.9 months in patients previously treated with CDK4/6 inhibitors.
The data was presented at the San Antonio Breast Cancer Symposium (SABCS) in December 2024. The trial results support Celcuity's clinical development strategy of simultaneously blocking ER, CDK4/6, and PAM signaling pathways, which forms the basis for their ongoing VIKTORIA-1 and planned VIKTORIA-2 Phase 3 trials.
Celcuity (CELC) ha annunciato i dati di sopravvivenza globale (OS) provenienti da uno studio di Fase 1b che valuta il gedatolisib in combinazione con il palbociclib e una terapia endocrina per il cancro al seno avanzato HR+, HER2-. Lo studio ha mostrato risultati promettenti con una sopravvivenza mediana di 77,3 mesi nei pazienti mai trattati e 33,9 mesi nei pazienti precedentemente trattati con inibitori CDK4/6.
I dati sono stati presentati al San Antonio Breast Cancer Symposium (SABCS) nel dicembre 2024. I risultati dello studio supportano la strategia di sviluppo clinico di Celcuity che prevede il blocco simultaneo delle vie di segnalazione ER, CDK4/6 e PAM, che costituisce la base per i loro attuali trial di Fase 3 VIKTORIA-1 e il pianificato VIKTORIA-2.
Celcuity (CELC) anunció datos de supervivencia general (OS) de un ensayo de Fase 1b que evalúa el gedatolisib en combinación con palbociclib y terapia endocrina para el cáncer de mama avanzado HR+, HER2-. El estudio mostró resultados prometedores con una supervivencia mediana de 77,3 meses en pacientes nunca tratados y 33,9 meses en pacientes tratados previamente con inhibidores de CDK4/6.
Los datos se presentaron en el Simposio de Cáncer de Mama de San Antonio (SABCS) en diciembre de 2024. Los resultados del ensayo apoyan la estrategia de desarrollo clínico de Celcuity de bloquear simultáneamente las vías de señalización ER, CDK4/6 y PAM, que forman la base para sus ensayos de Fase 3 en curso VIKTORIA-1 y el planificado VIKTORIA-2.
Celcuity (CELC)는 HR+, HER2- 진행성 유방암에 대한 팔보시클립과 내분비 요법과 함께 겐다톨리시브를 평가한 1b상 시험의 전체 생존(OS) 데이터를 발표했습니다. 이 연구는 치료를 받지 않은 환자에서 중위 생존 기간이 77.3개월이며, CDK4/6 억제제로 이전에 치료를 받은 환자에서 33.9개월로 나타났습니다.
이 데이터는 2024년 12월 샌안토니오 유방암 심포지엄(SABCS)에서 발표되었습니다. 시험 결과는 ER, CDK4/6 및 PAM 신호 경로를 동시에 차단하는 Celcuity의 임상 개발 전략을 지원하며, 이는 현재 진행 중인 VIKTORIA-1과 계획된 VIKTORIA-2 3상 시험의 기초가 됩니다.
Celcuity (CELC) a annoncé des données sur la survie globale (OS) issues d'un essai de Phase 1b évaluant le gedatolisib en combinaison avec le palbociclib et une thérapie endocrinienne pour le cancer du sein avancé HR+, HER2-. L'étude a montré des résultats prometteurs avec une survie médiane de 77,3 mois chez des patients n'ayant jamais été traités et 33,9 mois chez des patients ayant été auparavant traités avec des inhibiteurs CDK4/6.
Les données ont été présentées au San Antonio Breast Cancer Symposium (SABCS) en décembre 2024. Les résultats de l'essai soutiennent la stratégie de développement clinique de Celcuity qui consiste à bloquer simultanément les voies de signalisation ER, CDK4/6 et PAM, ce qui constitue la base de leurs essais de Phase 3 en cours VIKTORIA-1 et du prévu VIKTORIA-2.
Celcuity (CELC) hat Daten zur Gesamtüberlebensrate (OS) aus einer Phase-1b-Studie vorgestellt, die Gedatolisib in Kombination mit Palbociclib und endokriner Therapie bei HR+, HER2- fortgeschrittenem Brustkrebs untersucht. Die Studie zeigte vielversprechende Ergebnisse mit einer mittleren OS von 77,3 Monaten bei zuvor nicht behandelten Patienten und 33,9 Monaten bei Patienten, die zuvor mit CDK4/6-Inhibitoren behandelt wurden.
Die Daten wurden im Dezember 2024 auf dem San Antonio Breast Cancer Symposium (SABCS) präsentiert. Die Ergebnisse der Studie unterstützen die klinische Entwicklungsstrategie von Celcuity, die gleichzeitig die ER-, CDK4/6- und PAM-Signalwege blockiert, was die Grundlage für ihre laufenden Phase-3-Studien VIKTORIA-1 und den geplanten VIKTORIA-2 bildet.
- Strong median OS of 77.3 months in treatment-naïve patients
- Favorable OS of 33.9 months in previously treated patients
- Results support ongoing Phase 3 trials VIKTORIA-1 and VIKTORIA-2
- None.
Insights
The Phase 1b survival data for gedatolisib shows promising results in breast cancer treatment. The 77.3-month median overall survival in treatment-naïve patients is particularly noteworthy, suggesting strong efficacy in first-line settings. The 33.9-month survival in previously treated patients also indicates meaningful clinical benefit in more challenging second-line scenarios.
The triple pathway blockade strategy (ER, CDK4/6 and PAM signaling) represents an innovative approach that could potentially address resistance mechanisms common in breast cancer treatment. This data supports the ongoing Phase 3 VIKTORIA-1 trial and planned VIKTORIA-2 study, positioning gedatolisib as a potential key player in both first and second-line treatment landscapes for HR+/HER2- advanced breast cancer.
These strong survival data significantly enhance gedatolisib's commercial potential and Celcuity's market position. With a
The dual-phase 3 strategy targeting both first and second-line treatments expands the potential market opportunity substantially. Success in either indication could translate to significant revenue potential, given the large addressable market for HR+/HER2- breast cancer treatments.
Median overall survival (OS) among patients with HR+, HER2- advanced breast cancer who were treatment-naïve in the advanced setting was 77.3 months
Median OS among patients previously treated with a CDK4/6 inhibitor was 33.9 months
MINNEAPOLIS, Dec. 11, 2024 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced overall survival (OS) data from two patient cohorts evaluated in a Phase 1b trial with gedatolisib, a pan-PI3K/mTORC1/2 inhibitor, in combination with palbociclib and either letrozole or fulvestrant, in patients with HR+, HER2-advanced or metastatic breast cancer. Results will be presented in a poster session at the San Antonio Breast Cancer Symposium (SABCS) being held December 10-13 at the Henry B. Gonzalez Convention Center in San Antonio, Texas.
The poster presents overall survival data among patients with HR+, HER2- advanced breast cancer who were either treatment-naïve (N=41) or whose disease progressed during prior treatment with a CDK4/6 inhibitor (N=27). For the treatment-naïve patient cohort (Escalation Arm A and Expansion Arm A), median OS was 77.3 months (
“The median OS results reported for gedatolisib in combination with palbociclib and endocrine therapy are encouraging and compare favorably to published data for currently available first- or second-line standard-of-care regimens for patients with HR+/HER2- advanced breast cancer,” said Igor Gorbatchevsky, MD, Chief Medical Officer of Celcuity. “These results highlight the promising clinical development strategy of simultaneously blocking the ER, CDK4/6, and PAM (PI3K/AKT/mTOR) signaling pathways. This approach provided the rationale for our two Phase 3 clinical trials, the ongoing VIKTORIA-1 and planned VIKTORIA-2, which are and will be evaluating this treatment strategy in patients with HR+, HER2- advanced breast cancer in the second- and first-line setting, respectively.”
This poster, and two additional posters presenting nonclinical data for gedatolisib at the SABCS, are available on the publications page of the Celcuity website.
About Gedatolisib
Gedatolisib is a potent, reversible inhibitor that selectively targets all Class I PI3K isoforms and mTORC1 and mTORC2 to blockade PI3K/AKT/mTOR signaling activity. Its mechanism of action and pharmacokinetic properties are highly differentiated from other currently approved and investigational therapies that target PI3K, AKT, or mTOR alone or together. Inhibiting all four Class I PI3K isoforms and mTORC1/2 limits the potential development of drug resistance compared with isoform-specific PI3K, AKT or mTOR specific inhibitors. A robust response rate and a manageable side effect profile were reported for the Phase 1b clinical trial that evaluated gedatolisib in combination with palbociclib and endocrine therapy in patients with HR+/HER2- advanced breast cancer. Gedatolisib, in combination with palbociclib and fulvestrant, has been granted U.S. Food and Drug Administration (FDA) Breakthrough Therapy designation for the treatment of HR+/HER2- advanced breast cancer that has progressed following treatment with a CDK4/6 inhibitor in combination with an aromatase inhibitor.
About Celcuity
Celcuity is a clinical-stage biotechnology company focused on development of targeted therapies for treatment of multiple solid tumor indications. The company's lead therapeutic candidate is gedatolisib, a potent, pan-PI3K and mTOR inhibitor. Its mechanism of action and pharmacokinetic properties are highly differentiated from other currently approved and investigational therapies that target PI3K or mTOR 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- advanced breast cancer is currently enrolling patients. More detailed information about the VIKTORIA-1 study can be found at ClinicalTrials.gov. A Phase 1b/2 clinical trial, CELC-G-201, evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer, is enrolling patients. A Phase 3 clinical trial, VIKTORIA-2, evaluating gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for patients with HR+/HER2- advanced breast cancer is expected to begin enrolling patients in the second quarter of 2025. Celcuity is headquartered in Minneapolis. Further information about Celcuity can be found at www.celcuity.com. Follow us on LinkedIn and Twitter.
Forward-Looking Statements
This press release contains statements that constitute "forward-looking statements" including, but not limited to, the design of our clinical trials; the timing of initiating and enrolling patients in, and receiving results and data from, our clinical trials; the costs and expected results from any ongoing or planned clinical trials; the market opportunity for gedatolisib; revenue expectations; our strategy, marketing and commercialization plans, including the benefits of strategic decisions regarding studies and trials; other expectations with respect to Celcuity's lead product candidate, gedatolisib, and its CELsignia platform; our anticipated use of cash; and the strength of our balance sheet. In some cases, you can identify forward-looking statements by terminology such as "may," "should," "expects," "plans," "anticipates," "believes," "estimates," "predicts," "potential," "intends" or "continue," and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. Forward-looking statements are subject to numerous risks, uncertainties, and conditions, many of which are beyond the control of Celcuity. These include, but are not limited to, unforeseen delays in our clinical trials, our ability to obtain and maintain regulatory approvals to commercialize our products, and the market acceptance of such products, the development of therapies and tools competitive with our products, our ability to access capital upon favorable terms or at all, and those risks set forth in the Risk Factors section in Celcuity's Annual Report on Form 10-K for the year ended December 31, 2023 filed with the Securities and Exchange Commission on March 27, 2024. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Celcuity undertakes no obligation to update these statements for revisions or changes after the date of this press release, except as required by law.
View source version of release on GlobeNewswire.com
Contacts:
Celcuity Inc.
Brian Sullivan, bsullivan@celcuity.com
Vicky Hahne, vhahne@celcuity.com
(763) 392-0123
ICR Healthcare
Patti Bank, patti.bank@icrhealthcare.com
(415) 513-1284
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