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Point Biopharma Begins Dosing Prostate Cancer Patients With Radioligand Therapy in SPLASH Trial

NEW YORK – Point Biopharma on Friday said it has begun dosing PSMA-expressing, metastatic castration-resistant prostate cancer, or mCRPC, patients with PNT2002, an investigational 177Lu-PSMA targeted radioligand therapy, in the Phase III SPLASH trial.

The randomized trial will enroll around 450 PSMA-expressing mCRPC patients who are ineligible for chemotherapy in North America, the UK, and Europe. The first part of the trial involves a safety and dosimetry lead-in in 25 patients. Next, approximately 390 patients receive either PNT2002 or anti-androgen therapy abiraterone (Janssen's Zytiga) or enzalutamide (Pfizer/Astellas Pharma's Xtandi) and are followed for at least five years. Patients who experience radiographic progression may cross over to the PNT2002 arm.

Researchers are tracking radiographic progression-free survival as the primary endpoint. They will also follow patients to gauge their overall response rate, overall survival, and pharmacokinetics.

"There is a significant unmet need for therapeutic alternatives with a novel mechanism of action for patients with PSMA-expressing mCRPC, particularly in advance of chemotherapy," said Luke Nordquist, a urologic medical oncologist at the Urology Cancer Center & GU Research Network in Omaha, Nebraska, where some of the first patients received PNT2002 last month in the SPLASH trial.

"The current standard of care is not sufficient for patients with this aggressive form of cancer," he said, adding that he has seen increasing demand for radioligand therapies and believes "it holds much promise as the future of precision medicine."