Celcuity Announces First Patient Dosed in Phase 3 VIKTORIA-2 Clinical Trial of Gedatolisib as a First-Line Treatment for HR+/HER2- Advanced Breast Cancer
Celcuity (NASDAQ:CELC) has initiated patient dosing in its Phase 3 VIKTORIA-2 clinical trial, evaluating gedatolisib combination therapy as a first-line treatment for HR+/HER2- advanced breast cancer (ABC) patients with endocrine therapy resistance.
Gedatolisib, a novel multi-target PI3K/AKT/mTOR inhibitor, demonstrated promising results in a Phase 1b trial when combined with palbociclib and letrozole, achieving a median progression-free survival of 48.6 months, median overall survival of 77.3 months, and an objective response rate of 79%.
The VIKTORIA-2 study aims to evaluate gedatolisib's efficacy in combination with CDK4/6 inhibitor and fulvestrant, regardless of patients' PIK3CA status or metabolic profile.
Celcuity (NASDAQ:CELC) ha iniziato la somministrazione ai pazienti nel suo trial clinico di Fase 3 VIKTORIA-2, che valuta la terapia combinata con gedatolisib come trattamento di prima linea per pazienti con carcinoma mammario avanzato (ABC) HR+/HER2- resistenti alla terapia endocrina.
Gedatolisib, un nuovo inibitore multi-target di PI3K/AKT/mTOR, ha mostrato risultati promettenti in uno studio di Fase 1b in combinazione con palbociclib e letrozolo, raggiungendo una sopravvivenza libera da progressione mediana di 48,6 mesi, una sopravvivenza globale mediana di 77,3 mesi e un tasso di risposta obiettiva del 79%.
Lo studio VIKTORIA-2 mira a valutare l鈥檈fficacia di gedatolisib in combinazione con l鈥檌nibitore CDK4/6 e fulvestrant, indipendentemente dallo stato PIK3CA o dal profilo metabolico dei pazienti.
Celcuity (NASDAQ:CELC) ha iniciado la dosificaci贸n de pacientes en su ensayo cl铆nico de Fase 3 VIKTORIA-2, que eval煤a la terapia combinada con gedatolisib como tratamiento de primera l铆nea para pacientes con c谩ncer de mama avanzado (ABC) HR+/HER2- resistentes a la terapia endocrina.
Gedatolisib, un novedoso inhibidor multitarget de PI3K/AKT/mTOR, mostr贸 resultados prometedores en un ensayo de Fase 1b combinado con palbociclib y letrozol, alcanzando una supervivencia libre de progresi贸n mediana de 48,6 meses, una supervivencia global mediana de 77,3 meses y una tasa de respuesta objetiva del 79%.
El estudio VIKTORIA-2 tiene como objetivo evaluar la eficacia de gedatolisib en combinaci贸n con el inhibidor CDK4/6 y fulvestrant, independientemente del estado PIK3CA o perfil metab贸lico de los pacientes.
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Celcuity (NASDAQ:CELC) a commenc茅 le traitement des patients dans son essai clinique de phase 3 VIKTORIA-2, qui 茅value la th茅rapie combin茅e 脿 base de gedatolisib en traitement de premi猫re ligne pour les patientes atteintes d鈥檜n cancer du sein avanc茅 (ABC) HR+/HER2- r茅sistant 脿 l鈥檋ormonoth茅rapie.
Gedatolisib, un inhibiteur multi-cible PI3K/AKT/mTOR innovant, a montr茅 des r茅sultats prometteurs lors d鈥檜n essai de phase 1b en association avec palbociclib et l茅trozole, atteignant une survie sans progression m茅diane de 48,6 mois, une survie globale m茅diane de 77,3 mois et un taux de r茅ponse objective de 79%.
L鈥櫭﹖ude VIKTORIA-2 vise 脿 茅valuer l鈥檈fficacit茅 de gedatolisib en combinaison avec un inhibiteur CDK4/6 et le fulvestrant, ind茅pendamment du statut PIK3CA ou du profil m茅tabolique des patientes.
Celcuity (NASDAQ:CELC) hat mit der Dosierung von Patienten in der Phase-3-Studie VIKTORIA-2 begonnen, die die Kombinationstherapie mit Gedatolisib als Erstlinientherapie f眉r HR+/HER2- fortgeschrittene Brustkrebspatienten (ABC) mit endokriner Therapieresistenz bewertet.
Gedatolisib, ein neuartiger Multi-Target-PI3K/AKT/mTOR-Inhibitor, zeigte vielversprechende Ergebnisse in einer Phase-1b-Studie in Kombination mit Palbociclib und Letrozol und erreichte ein medianes progressionsfreies 脺berleben von 48,6 Monaten, ein medianes Gesamt眉berleben von 77,3 Monaten und eine objektive Ansprechrate von 79%.
Die VIKTORIA-2-Studie zielt darauf ab, die Wirksamkeit von Gedatolisib in Kombination mit einem CDK4/6-Inhibitor und Fulvestrant zu bewerten, unabh盲ngig vom PIK3CA-Status oder metabolischen Profil der Patienten.
- Phase 1b trial showed impressive results with 48.6 months median progression-free survival
- Strong overall survival of 77.3 months in Phase 1b trial
- High objective response rate of 79% in previous trial
- Potential to address unmet medical need in endocrine therapy resistant patients
- None.
Insights
Celcuity's Phase 3 trial initiation for gedatolisib in breast cancer represents significant pipeline advancement with promising early efficacy data.
Celcuity has reached a crucial milestone with the dosing of the first patient in its Phase 3 VIKTORIA-2 trial for gedatolisib, signaling the advancement of their lead asset into the final stage of clinical development before potential regulatory submission. This trial specifically targets HR+/HER2- advanced breast cancer patients with endocrine therapy resistance as a first-line treatment option.
The compound's mechanism of action is particularly noteworthy - gedatolisib is a multi-target PAM pathway inhibitor that comprehensively blocks all four class I PI3K isoforms along with mTORC1 and mTORC2. This broad inhibition strategy differentiates it from existing single-target PI3K inhibitors which have shown limitations in efficacy and tolerability.
The preliminary data cited from the Phase 1b trial shows impressive efficacy signals:
The trial design appears to address an important unmet need - patients whose disease progressed during or shortly after adjuvant endocrine therapy. What's particularly meaningful is the intention to evaluate efficacy regardless of PIK3CA mutation status or metabolic profile, potentially broadening the addressable patient population compared to more genetically restricted treatment approaches.
MINNEAPOLIS, July 24, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced that the first patient has been dosed in VIKTORIA-2, its Phase 3 clinical trial evaluating gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for patients with HR+/HER2- advanced breast cancer (鈥淎BC鈥�) who are endocrine therapy resistant. Gedatolisib is an investigational, multi-target PI3K/AKT/mTOR (鈥淧AM鈥�) inhibitor that potently targets all four class I PI3K isoforms, mTORC1, and mTORC2 to induce comprehensive blockade of the PAM pathway.
鈥淲e are excited to begin enrolling patients in the Phase 3 VIKTORIA-2 trial and advancing gedatolisib into the front-line setting for HR-positive, HER2-negative advanced breast cancer,鈥� said Igor Gorbatchevsky, M.D., Chief Medical Officer of Celcuity. 鈥淭reatment na茂ve patients with advanced breast cancer who are endocrine treatment resistant receive limited benefit from a CDK4/6 inhibitor and fulvestrant, the current standard of care regimen for most of these patients. In patients with endocrine sensitive HR+/HER2- advanced breast cancer who received gedatolisib in combination with palbociclib and letrozole in a Phase 1b clinical trial, median progression free survival was 48.6 months, median overall survival was 77.3 months, and the objective response rate was
鈥淭here is an urgent need for better first-line therapeutic options for HR+/HER2- advanced breast cancer patients whose disease progressed while on or within 12 months of completing adjuvant endocrine treatment for early breast cancer,鈥� said Giuseppe Curigliano, M.D., Ph.D., Director of the Early Drug Development Division and co-chair for the Experimental Therapeutics Program at the European Institute of Oncology and co-principal investigator for the VIKTORIA-2 clinical trial. 鈥淭he Phase 3 VIKTORIA-2 study aims to evaluate whether the gedatolisib triplet can induce a clinically meaningful benefit in patients regardless of the PIK3CA status of their tumor or their metabolic profile. We intend to generate a robust data package with the goal of bringing gedatolisib to the clinic as a potential first-line treatment.鈥�
About VIKTORIA-2
VIKTORIA-2 is a Phase 3 open-label, randomized clinical trial to evaluate the efficacy and safety of gedatolisib combined with fulvestrant plus a CDK4/6 inhibitor in comparison to fulvestrant plus a CDK4/6 inhibitor as first-line treatment for patients with HR+/HER2- ABC who are endocrine therapy resistant. For the CDK4/6 inhibitor, investigators may choose either ribociclib or palbociclib. Prior to enrolling patients in the Phase 3 portion of the study and confirming the Phase 3 dose with ribociclib, a safety run-in of approximately 12-36 subjects will evaluate the safety profile of gedatolisib combined with ribociclib and fulvestrant. The safety profile of gedatolisib combined with fulvestrant and palbociclib is well described, but the investigational combination of gedatolisib with ribociclib has not yet been clinically tested.
For the Phase 3 study, approximately 638 subjects who meet the eligibility criteria will be assigned to a cohort based on their PIK3CA mutation status. After the investigator selects the CDK4/6 inhibitor for a subject, the subject will then be randomly assigned on a 1:1 basis to either Arm A (gedatolisib, fulvestrant, and Investigator鈥檚 choice of ribociclib or palbociclib) or Arm B (fulvestrant and Investigator鈥檚 choice of ribociclib or palbociclib). This global trial is expected to enroll subjects at up to 200 clinical sites across North America, Europe, Latin America, and Asia. The clinical trial primary endpoints are progression free survival ("PFS"), per RECIST 1.1 criteria, as assessed by blinded independent central review. The primary PFS endpoints will be evaluated separately in subjects who are PI3KCA wild type and PI3KCA mutant.
About Celcuity
Celcuity is a clinical-stage biotechnology company pursuing development of targeted therapies for treatment of multiple solid tumor indications. The company'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伪, 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- advanced breast cancer is currently enrolling patients. More detailed information about the VIKTORIA-1 study can be found at .听 A Phase 1b/2 clinical trial, CELC-G-201, evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer, is ongoing. 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 currently enrolling patients. Celcuity is headquartered in Minneapolis. Further information about Celcuity can be found at听. Follow us on听听补苍诲听.
Forward-Looking Statements
This press release contains statements that constitute "forward-looking statements" 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; and other expectations with respect to gedatolisib. Words such as, but not limited to, 鈥渓ook forward to,鈥� 鈥渂elieve,鈥� 鈥渆xpect,鈥� 鈥渁nticipate,鈥� 鈥渆stimate,鈥� 鈥渋ntend,鈥� "confidence," "encouraged," 鈥減otential,鈥� 鈥減lan,鈥� 鈥渢argets,鈥� 鈥渓ikely,鈥� 鈥渕ay,鈥� 鈥渨ill,鈥� 鈥渨ould,鈥� 鈥渟hould鈥� and 鈥渃ould,鈥� and similar expressions or words identify forward-looking statements. The forward-looking statements included in this press release are based on management'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 planned NDA for gedatolisib; and our ability to obtain and maintain regulatory approvals to commercialize gedatolisib. 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.
Contacts:听
Celcuity Inc.听
Brian Sullivan, 听
Vicky Hahne, 听
(763) 392-0123听
ICR Healthcare
Patti Bank,
(415) 513-1284
FAQ
What is the purpose of Celcuity's VIKTORIA-2 Phase 3 trial for gedatolisib?
What were the key results from gedatolisib's Phase 1b trial?
How does gedatolisib work in treating breast cancer?
What patient population will VIKTORIA-2 study target?
Will PIK3CA status affect patient eligibility for the VIKTORIA-2 trial?
