Radspherin Shows Promise in Colorectal Cancer Peritoneal Metastases: Phase 1/2a Data
Key Insights
Phase 1/2a study of Radspherin® demonstrates encouraging safety and efficacy in colorectal cancer (search) patients with peritoneal metastases.
At 18 months, no peritoneal recurrences were observed in patients receiving the recommended dose of Radspherin® after cytoreductive surgery and HIPEC.
The study highlights the potential of Radspherin® as a novel treatment option for peritoneal metastases, addressing an urgent unmet need.
Oncoinvent (search) AS announced the publication of 18-month data from its Phase 1/2a study of Radspherin® in colorectal cancer (search) patients with peritoneal metastases, showcasing promising safety and efficacy results. The study, published in the Journal of Surgical Oncology, indicates that Radspherin® could offer a novel treatment approach for this challenging condition.
The Phase 1 portion of the RAD-18-002 study enrolled 23 patients with peritoneal metastases from colorectal cancer (search). The results revealed that none of the patients who received the recommended dose (7 MBq) of Radspherin® experienced peritoneal recurrences at the 18-month mark following cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (HIPEC).
Radspherin's Mechanism and Clinical Significance
Radspherin® is an investigational radiopharmaceutical designed for local cancer treatment in body cavities. It consists of calcium carbonate microparticles containing radium-224, which emits alpha-particles, delivering potent radiation directly to cancer cells. This targeted approach aims to minimize damage to surrounding healthy tissues.
Professor Emeritus Oyvind Bruland, MD, PhD, co-founder and member of Oncoinvent (search)’s scientific advisory board, commented, "The data in the publication highlights the potential of Radspherin® in treating patients with peritoneal metastases from colorectal cancer (search), a condition for which there is an urgent unmet need for novel treatment options."
Addressing an Unmet Need
Peritoneal metastases from colorectal cancer (search) represent a significant clinical challenge, with limited effective treatment options available. While treatments for liver and lung metastases have advanced, patients with peritoneal metastases often face a poor prognosis. The study's findings suggest that Radspherin® could fill this gap.
Dr. Stein G. Larsen, principal investigator of the study, noted the lack of benefit for peritoneal metastases patients from other new treatment options, underscoring the importance of exploring novel therapies like Radspherin®.
Study Details and Future Directions
The RAD-18-002 study is a Phase 1/2a open-label trial designed to determine the clinical dose and evaluate the safety, tolerability, and efficacy signal of intraperitoneally administered Radspherin® in patients with peritoneal metastases from colorectal cancer (search) undergoing cytoreduction and HIPEC. The study completed recruitment at the end of 2023, with results from an additional 24 patients pending.
The publication concludes that Radspherin® was well tolerated following cytoreductive surgery and HIPEC, warranting further clinical evaluation to confirm its efficacy in this patient population.