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Patient randomization has started in the pivotal phase 3 SPLASH trial exploring the novel PSMA-targeted therapy PNT2002 in patients with metastatic castration-resistant prostate cancer (mCRPC), according to POINT Biopharma, the developer of PNT2002.1
The randomization phase was launched after successful completion of the open-label dosimetry and safety run-in phase, in which all prespecified safety and efficacy criteria were met. There were 27 patients who 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 for PNT2002 to address an unmet need in mCRPC—an aggressive disease where patients often have poor prognosis,” said Neil Fleshner, MD, chief medical officer and co-founder of POINT Biopharma. “I am grateful for the immensely positive support of all the physicians and patients that are participating in this clinical program, and look forward to the expected completion of the study in 2023."
The open-label SPLASH trial (NCT04647526) is specifically enrolling patients whose tumors express PSMA; who have experienced disease progression on an androgen receptor–axis-targeted therapy (abiraterone acetate [Zytiga], enzalutamide [Xtandi], darolutamide [Nubeqa], or apalutamide [Erleada]) in either the castration-sensitive or CRPC setting; and who are not eligible for or decline chemotherapy.
The randomization phase of the study will assign patients in a 2:1 ratio to either PNT2002 (arm A) or abiraterone or enzalutamide (arm B).2 Crossover from the control arm to receive PNT2002 will be allowed at radiographic progression among patients who meet the study protocol eligibility criteria.
The targeted enrollment of the trial is 400 patients. Patients must have an ECOG performance status 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 enrollment for the randomization phase has started in Canada will continue at sites in North America, Europe, and the United Kingdom. The primary endpoint of the study is radiographic progression-free survival (rPFS). Other key end points 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 lead-in phase will be made available prior to that time. Overall, patients will continue to be followed for up to 5 years following their first treatment dose.
1. POINT Biopharma Announces Initiation of Randomization for its Phase 3 SPLASH study Evaluating PNT2002 for mCRPC. Posted online September 23, 2021. Accessed September 29, 2021. https://yhoo.it/3kUy69a.
2. United States National Institutes of Health National Library of Medicine. ClinicalTrials.gov. Study Evaluating mCRPC Treatment 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.