Curium and PDRadiopharma, a subsidiary of PeptiDream, have announced a collaboration to support the clinical development, regulatory filing, and commercialization of PSMA-targeting theranostics 177Lu-PSMA-I&T and 64Cu-PSMA-I&T in Japan. This partnership seeks to bring new diagnostic and therapeutic options to patients with prostate cancer in Japan, addressing a significant unmet need in the region.
Under the agreement, Curium will continue to lead global development of the agents while PDRadiopharma will spearhead regulatory filing, manufacturing, commercialization, and distribution activities within Japan. Curium will also support PDRadiopharma in establishing manufacturing capabilities in Japan.
Patrick C. Reid, president and CEO of PeptiDream, stated, "Targeted radiopharmaceuticals are rapidly revolutionizing how we both diagnose and treat cancer...we are thrilled to be able to accelerate those efforts by partnering with Curium to bring their highly promising prostate cancer targeting radiopharmaceuticals to patients in Japan."
Ongoing Clinical Trials
ECLIPSE Trial (177Lu-PSMA-I&T): The Phase 3 ECLIPSE trial (NCT05204927) is evaluating the safety and efficacy of 177Lu-PSMA-I&T compared to standard-of-care hormone therapy in patients with metastatic castration-resistant prostate cancer (mCRPC). The open-label, global trial has enrolled over 400 patients across 51 sites in the US and Europe. Patients are randomized 2:1 to receive either 177Lu-PSMA-I&T or hormone therapy (abiraterone with prednisone or enzalutamide). The primary endpoint is radiographic progression-free survival, assessed for up to 34 weeks. Secondary endpoints include overall survival, progression-free survival, PSA reduction rate (≥50%), and quality-of-life measures. Final study completion is anticipated in June 2029.
SOLAR Trials (64Cu-PSMA-I&T): The diagnostic performance of 64Cu-PSMA-I&T is being assessed in two Phase 3 trials: SOLAR RECUR (NCT06235099) and SOLAR STAGE (NCT06235151). These multicenter trials have enrolled patients across 50 sites in the US and over 30 sites in Europe.
- SOLAR RECUR: This trial is evaluating 64Cu-PSMA-I&T in patients with suspected biochemically recurrent prostate cancer after radical prostatectomy or radiation therapy. The prospective, open-label study plans to enroll approximately 200 patients. Co-primary endpoints are patient-level correct detection rate (CDR) and region-level correct localization rate (CLR). Secondary outcome measures include CDR and CLR by PSA level and histopathology status, inter- and intra-reader agreement, and adverse event incidence.
- SOLAR STAGE: This trial is assessing 64Cu-PSMA-I&T in patients with newly diagnosed unfavorable intermediate-risk, high-risk, or very high-risk prostate cancer planning to undergo radical prostatectomy with pelvic lymph node dissection. The study aims to enroll 323 patients who will receive an 8 mCi intravenous dose of 64Cu-PSMA-I&T prior to PET/CT imaging. The primary endpoints are sensitivity and specificity. Secondary endpoints include inter- and intra-reader agreement and adverse event incidence.
Completion of both SOLAR RECUR and SOLAR STAGE trials is expected in July 2025.
These Phase 3 studies build upon positive results from the Phase 1/2 SOLAR trial (NCT05653856), which met its co-primary endpoints of patient-level CDR and region-level CLR in patients with metastatic prostate cancer in August 2023. The trial enrolled 26 patients across US clinical trial sites.
