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”)

• 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, 61% had received one line of prior systemic therapy and 39% had received at least 2 or more lines of prior therapy. The Phase 1 data set utilized an August 15, 2025 data cut-off. Median duration of follow-up was 9.0 months.

The six-month rPFS rate and median rPFS for patients from both arms combined was 67% and 9.1 months, respectively. For patients treated with 120 mg gedatolisib, the six-month rPFS rate was 74% and median rPFS was 9.5 months. For patients treated with 180 mg gedatolisib, the six-month rPFS rate was 61% and the median rPFS was 7.4 months.

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 (5.3%), stomatitis (2.6%), and pruritus (2.6%); no Grade 3 hyperglycemia was reported. Additionally, no Grade 4 or 5 TRAEs were observed, and no patients discontinued study treatment due to a TRAE.

“We are very encouraged by this Phase 1 efficacy and safety data,” said Igor Gorbatchevsky, MD, Chief Medical Officer of Celcuity. “The 67% six-month rPFS rate and median rPFS of 9.1 months for this novel combination therapy compares favorably to published data for androgen receptor inhibitors in this setting. We are now enrolling patients in our updated Phase 1/1b portion of this clinical trial to determine the recommended Phase 2 dose.”