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.

Other key end points include overall response rate, overall survival, biochemical PFS, duration of response, pharmacokinetics, and safety. The primary end point of the study is radiographic progression-free survival (rPFS).

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 randomization phase of the study assigned patients in a 2:1 ratio to either PNT2002 (arm A) or abiraterone or enzalutamide (arm B). 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). The open-label SPLASH trial (NCT04647526) specifically enrolled patients whose tumors express PSMA who have experienced disease progression on an androgen receptor–axis-targeted therapy (abiraterone acetate, enzalutamide, darolutamide, or apalutamide ) in either the castration-sensitive or CRPC setting and who are not eligible for or decline chemotherapy. “We are grateful for patients who agreed to be screened for this study, the trial investigators and their hard-working staff, our research partners, and the POINT team for their passion and commitment to the program.” “We are proud to have reached this important milestone for the PNT2002 program,” Jessica Jensen, executive vice president, Clinical Development of POINT Biopharma, stated in a press release. There were 27 patients who participated in this phase. 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 are now more than 390 patients enrolled and randomized in the trial at locations in 55 sites across North America, Europe, and the United Kingdom.

Phase 10 splash