Celcuity Presents Updated Data at the 2025 ESMO Congress from Phase 1 Study Evaluating Gedatolisib Plus Darolutamide in Men with Metastatic Castration Resistant Prostate Cancer (“mCRPC”)
Celcuity (NASDAQ: CELC) reported updated Phase 1 data (data cut-off Aug 15, 2025) for gedatolisib plus darolutamide in men with metastatic castration resistant prostate cancer (mCRPC).
Key results for 38 patients with median follow-up 9.0 months: combined six-month radiographic PFS 67% and median rPFS 9.1 months. By dose: 120 mg gedatolisib — six-month rPFS 74%, median rPFS 9.5 months; 180 mg — six-month rPFS 61%, median rPFS 7.4 months.
Safety: no dose-limiting toxicities, no Grade 4/5 TRAEs, no treatment discontinuations due to TRAEs; Grade 3 TRAEs included rash 5.3%, stomatitis 2.6%, pruritus 2.6%. The company is enrolling an amended Phase 1/1b to identify the recommended Phase 2 dose.
Celcuity (NASDAQ: CELC) ha riportato dati aggiornati di fase 1 (taglio dati del 15 agosto 2025) per gedatolisib più darolutamide negli uomini con cancro della prostata metastatico resistente alla castrazione (mCRPC).
Risultati chiave per 38 pazienti con follow-up mediano 9,0 mesi: controllo radiografico di PFS a sei mesi combinato 67% e PFS mediana rPFS 9,1 mesi. Per dose: 120 mg gedatolisib — rPFS a sei mesi 74%, rPFS mediana 9,5 mesi; 180 mg — rPFS a sei mesi 61%, rPFS mediana 7,4 mesi.
Sicurezza: nessuna tossicità dose-dipendente limitante, nessun TRAE di Grado 4/5, nessuna interruzione del trattamento per TRAE; TRAE di Grado 3 incluse eritema 5,3%, stomatite 2,6%, prurito 2,6%. L’azienda sta conducendo un aggiornamento della Fase 1/1b per identificare la dose raccomandata per la fase 2.
Celcuity (NASDAQ: CELC) informó datos actualizados de fase 1 (corte de datos 15 de agosto de 2025) para gedatolisib más darolutamida en hombres con cáncer de próstata metastásico resistente a la castración (mCRPC).
Resultados clave para 38 pacientes con seguimiento mediano de 9,0 meses: PFS radiográfico a seis meses combinada 67% y PFS mediana rPFS 9,1 meses. Por dosis: 120 mg gedatolisib — PFS rPFS a seis meses 74%, rPFS mediana 9,5 meses; 180 mg — PFS rPFS a seis meses 61%, rPFS mediana 7,4 meses.
Seguridad: sin toxicidad límite de dosis, sin TRAEs de Grado 4/5, sin interrupciones del tratamiento por TRAEs; TRAEs de Grado 3 incluyeron erupción cutánea 5,3%, estomatitis 2,6%, prurito 2,6%. La compañía está inscribiendo una fase 1/1b enmendada para identificar la dosis recomendada para la fase 2.
Celcuity (NASDAQ: CELC)은 mCRPC(전이성 거세저항성 전립선암) 남성 환자에서 gedatolisib와 darolutamide를 병용한 1상 업데이트 데이터를 공개했습니다(데이터 컷오프 2025년 8월 15일).
메디안 추적기간 9.0개월인 38명 환자에 대한 주요 결과: 6개월 방사학적 PFS를 합친 값은 67%이고 중간 PFS(rPFS)는 9.1개월입니다. 용량별로: 120 mg gedatolisib — 6개월 rPFS 74%, 중간 rPFS 9.5개월; 180 mg — 6개월 rPFS 61%, 중간 rPFS 7.4개월.
안전성: 용량 한계를 초과하는 독성 없음, 4/5급 TRAE 없음, TRAE로 인한 치료 중단 없음; 3급 TRAE로는 발진 5.3%, 구강점막염 2.6%, 가려움증 2.6%이 포함됩니다. 회사는 권고 2상 용량을 식별하기 위해 수정된 1상/1b를 등록 중입니다.
Celcuity (NASDAQ: CELC) a rapporté des données mises à jour de phase 1 (cut-off des données 15 août 2025) pour gedatolisib plus darolutamide chez les hommes atteints d’un cancer de la prostate métastatique résistant après ablation testiculaire (mCRPC).
Résultats clés pour 38 patients avec un suivi médian de 9,0 mois : PFS radiologique à six mois combiné 67% et PFS médiane rPFS 9,1 mois. Par dose : 120 mg gedatolisib — rPFS à six mois 74%, rPFS médiane 9,5 mois; 180 mg — rPFS à six mois 61%, rPFS médiane 7,4 mois.
Sécurité : pas de toxicité limitant la dose, pas de TRAEs de Grade 4/5, pas d’interruption du traitement due aux TRAEs; les TRAEs de Grade 3 incluent érythème 5,3%, stomatite 2,6%, prurit 2,6%. La société mène une phase 1/1b amendée pour identifier la dose recommandée pour la phase 2.
Celcuity (NASDAQ: CELC) berichtete aktualisierte Phase-1-Daten (Daten-Cutoff 15. August 2025) für Gedatolisib plus Darolutamid bei Männern mit metastasiertem kastrationsresistentem Prostatakrebs (mCRPC).
Schlüsselergebnisse für 38 Patienten mit medianem Follow-up von 9,0 Monaten: kombinierte six-month radiografische PFS 67% und medianer rPFS 9,1 Monate. Nach Dosis: 120 mg Gedatolisib — six-month rPFS 74%, medianer rPFS 9,5 Monate; 180 mg — six-month rPFS 61%, medianer rPFS 7,4 Monate.
Sicherheit: keine dosislimitierenden Toxizitäten, keine TRAEs Grad 4/5, keine Therapiebewertungen aufgrund TRAEs; TRAEs Grad 3 einschließlich Hautausschlag 5,3%, Stomatitis 2,6%, Pruritus 2,6%. Das Unternehmen rekrutiert eine geänderte Phase-1/1b, um die empfohlene Phase-2-Dosis zu identifizieren.
سيكلوتي (Nasaq CELC) أصدرت بيانات مُحدّثة للمرحلة 1 (قطع البيانات 31 أغسطس 2025) لـ gedatolisib مع دارولوتاميد لدى الرجال المصابين بسرطان البروستاتا المنتشر المقاوم للخصي (mCRPC).
نتائج رئيسية لـ 38 مريضاً بمتابعة وسيطة 9.0 أشهر: البقاء الخالي من التقدم الإشعاعي خلال ستة أشهر مجتمعا 67% وبقاء المرض المتوسط rPFS 9.1 أشهر. حسب الجرعة: 120 mg gedatolisib — six-month rPFS 74%, median rPFS 9.5 أشهر; 180 mg — 61% و 7.4 أشهر.
السلامة: لا سموم حدِّية للجرعة، لا TRAEs من الدرجة 4/5، لا إنهاء العلاج بسبب TRAEs؛ TRAEs من الدرجة 3 شملت طفح جلدي 5.3%، التهاب الفم 2.6%، حكة 2.6%. الشركة تقوم بتسجيل تعديل في المرحلة 1/1b لتحديد جرعة المرحلة 2 الموصى بها.
Celcuity (NASDAQ: CELC) 已更新第一阶段数据（数据截止日期2025年8月15日）关于gedatolisib 加 darolutamide在转移性去势抵抗性前列腺癌（mCRPC）男性中的应用。
38名患者，中位随访时间为9.0月的关键结果：六个月的放射学PFS综合为67%，中位rPFS为9.1月。按剂量：120 mg gedatolisib——六个月rPFS 74%，中位rPFS 9.5月；180 mg——六个月rPFS 61%，中位rPFS 7.4月。
安全性：无剂量限制性毒性，无4/5级TRAE，無因TRAE导致的治疗中止；3级TRAE包括皮疹5.3%、口腔炎2.6%、瘙痒2.6%。公司正在招募经修订的1/1b期以确定第二阶段的推荐剂量。
- Six-month rPFS of 67% (combined)
- Median rPFS of 9.1 months (combined)
- No dose-limiting toxicities observed
- No patients discontinued treatment due to a TRAE
- Smaller Phase 1 cohort of 38 patients
- Higher 180 mg arm median rPFS of 7.4 months vs 9.5 months at 120 mg
- Grade 3 rash occurred in 5.3% of patients
Insights
Phase 1 combination data show manageable safety and a
The combination of gedatolisib and darolutamide demonstrated a median radiographic progression-free survival of
These facts imply a tolerable early safety profile and enough efficacy signal to justify expanded dose exploration. Key dependencies include how the amended Phase 1/1b selects the RP2D and whether the larger cohorts reproduce the observed rPFS benefit. Monitor enrollment and dose-selection readouts from the amended Phase 1/1b and the planned Phase 2 expansion, especially the randomized Phase 1b cohorts and the target of approximately 30 subjects at the RP2D; near-term milestones will come as those cohorts mature after the
- Median radiographic progression free survival (“rPFS”) was 9.1 months and the six-month rPFS rate was
67% - No patients discontinued study treatment due to a treatment-related adverse event (“TRAE”)
MINNEAPOLIS, Oct. 18, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced updated clinical results from the Phase 1 portion of a clinical trial evaluating gedatolisib in combination with Nubeqa® (darolutamide), an androgen receptor inhibitor, in men with mCRPC whose disease had progressed on prior treatment with a next generation androgen receptor inhibitor. These data were presented at a poster presentation at the European Society of Medical Oncology (ESMO) today, Saturday, at 6:00 a.m. ET/12:00 p.m. CEST.
In this Phase 1 study, 38 patients with mCRPC were randomly assigned to receive 600 mg darolutamide twice daily combined with either 120 mg gedatolisib in Arm 1 or 180 mg gedatolisib in Arm 2. In both arms, gedatolisib was administered once weekly for three weeks, then one week off. Additionally, all patients received prophylactic treatment for stomatitis. Among the 38 patients enrolled,
The six-month rPFS rate and median rPFS for patients from both arms combined was
The combination of gedatolisib and darolutamide was generally well tolerated in the trial with mostly low-grade TRAEs. No dose limiting toxicities were observed in either arm. The only Grade 3 TRAEs for patients from both arms combined included rash (
“We are very encouraged by this Phase 1 efficacy and safety data,” said Igor Gorbatchevsky, MD, Chief Medical Officer of Celcuity. “The
In the amended Phase 1/1b portion of the clinical trial, up to six patients are planned to be enrolled in each of three arms and treated with different doses. Upon completion of Phase 1, up to an additional 40 patients will be randomly assigned to up to four Phase 1b cohorts to determine the recommended Phase 2 dose (“RP2D”). Dose levels will be selected based on the results from the Phase 1 clinical trial. In the Phase 2 dose expansion study, which will include subjects from the Phase 1/1b clinical trial, up to 18 additional subjects will be enrolled to achieve a total of approximately 30 subjects treated with the RP2D. All patients will also receive standard doses of darolutamide.
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 PI3Kα, 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 PIK3CA WT cohort and has completed enrollment of patients for the PIK3CA mutant cohort. 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- 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’s active clinical trials can be found at ClinicalTrials.gov. Celcuity is headquartered in Minneapolis. Further information about Celcuity can be found at www.celcuity.com. Follow us on LinkedIn and X.
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; our interpretation of topline clinical trial data; and other expectations with respect to gedatolisib. Words such as, but not limited to, “look forward to,” “believe,” “expect,” “anticipate,” “estimate,” “intend,” "confidence," "encouraged," “potential,” “plan,” “targets,” “likely,” “may,” “will,” “would,” “should” and “could,” 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 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.
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
FAQ
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