Beginning of randomization in the pivotal phase 3 mCRPC trial of a new treatment targeting PSMA
Patient randomization has begun in the pivotal phase 3 SPLASH trial exploring the novel PNT2002 treatment targeting PSMA in patients with metastatic castration-resistant prostate cancer (mCRPC), according to POINT Biopharma, the developer of PNT2002.1
The randomization phase was initiated after the successful completion of the open-label dosimetry and safety pre-inclusion phase, during which all predefined safety and efficacy criteria were met. 27 patients participated in this phase. POINT plans to share the data from this initial phase at a future medical meeting.
“As a practicing uro-oncologist, I am strongly encouraged by our results and the potential of PNT2002 to address an unmet need for mCRPC, an aggressive disease where patients often have a poor prognosis,” said Neil Fleshner, MD, medical director and co. -Founder of POINT Biopharma. “I am grateful for the overwhelmingly positive support from all of the physicians and patients participating in this clinical program, and look forward to the planned completion of the study in 2023.”
The open-label SPLASH trial (NCT04647526) specifically recruits patients whose tumors express PSMA; who have experienced disease progression with targeted therapy on the androgen receptor axis (abiraterone acetate [Zytiga], enzalutamide [Xtandi], darolutamide [Nubeqa], or apalutamide [Erleada]) in the castration sensitive setting or CRPC; and who are ineligible or refuse chemotherapy.
The randomization phase of the study will affect patients in a 2: 1 ratio of either PNT2002 (arm A), abiraterone or enzalutamide (arm B).2 Crossing the control arm to receive PNT2002 will be allowed for radiographic progression in patients who meet the eligibility criteria of the study protocol.
The target recruitment for the trial is 400 patients. Patients should have an ECOG performance index of 0 to 1 and a positive PSMA-PET scan on a validated test, such as 68Ga-PSMA-11 or 18F-DCFPyL (piflufolastat F 18; Pylarify).
Patient recruitment for the randomization phase has started in Canada and will continue at sites in North America, Europe and the UK. The primary endpoint of the study is radiographic progression-free survival (rPFS). Other key endpoints include overall response rate, overall survival, biochemical PFS, duration of response, pharmacokinetics, and safety.
The estimated primary completion date for the randomization phase is March 2023; however, data from the introductory phase will be available before this date. Overall, patients will continue to be followed for up to 5 years after their first dose of treatment.
1. POINT Biopharma announces the launch of randomization for its phase 3 SPLASH study evaluating PNT2002 for mCRPC. Published online September 23, 2021. Accessed September 29, 2021. https://yhoo.it/3kUy69a.
2. National Institutes of Health US National Library of Medicine. ClinicalTrials.gov. Study Evaluating Treatment of mCRPC Using PSMA [Lu-177]-PNT2002 therapy after second-line hormonal treatment (SPLASH). Site last updated July 29, 2021. Accessed August 11, 2021. https://www.clinicaltrials.gov/ct2/show/NCT04647526.