Patient enrollment is now complete for the randomization component of the phase 3 SPLASH trial exploring PNT2002 in patients with metastatic castration-resistant prostate cancer (mCRPC), according to POINT Biopharma, the developer of the novel PSMA-targeted therapy.1
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. 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.
“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. “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.”
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 [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. 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 randomization phase of the study assigned 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 primary end point 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.
Based on a strategic collaboration that POINT entered into with Lantheus Holdings, POINT is funding the SPLASH trial and Lantheus, in collaboration with POINT, will be responsible for filing a New Drug Application with the FDA should it be warranted by the SPLASH results.
1. POINT Biopharma Completes Randomization in PNT2002’s Phase 3 SPLASH Trial. Published online and accessed January 12, 2023. https://yhoo.it/3ZxaHNx.
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.