Oncoinvent Announces Publication of 18-Month Safety and Efficacy Data from the Phase 1/2a Study of Radspherin® in Colorectal Cancer

On November 1, 2024 Oncoinvent AS, a clinical stage company advancing alpha emitter therapy across a variety of solid cancers, reported the publication of data from the Phase 1/2a study of Radspherin in colorectal cancer patients in the peer-reviewed Journal of Surgical Oncology (Press release, Oncoinvent, NOV 1, 2024, View Source [SID1234647643]). The results, previously presented at the 2023 Peritoneal Surface Oncology Group International (PSOGI) Congress in Venice, show encouraging 18 months safety and efficacy data from the 23 patients enrolled in the Phase 1 part of the RAD-18-002 study in colorectal cancer patients.

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"We are pleased to see our data published in such a well-recognized scientific journal," commented Professor Emeritus Oyvind Bruland, MD, PhD, senior author on the manuscript, co-founder and member of Oncoinvent’s scientific advisory board. "The data in the publication highlights the potential of Radspherin in treating patients with peritoneal metastases from colorectal cancer, a condition for which there is an urgent unmet need for novel treatment options."

"Patients with liver and lung metastases benefit considerably from several other new treatment options, but not those with peritoneal metastases," commented Stein G. Larsen, MD, PhD, principal investigator of the study and chief gastrosurgeon, the Norwegian Radium Hospital, Oslo University Hospital.

The publication concludes that Radspherin was well tolerated following cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (HIPEC). At 18 months, none of the patients receiving the recommended dose (7 MBq) had peritoneal recurrences. Radspherin also showed a promising signal of efficacy warranting further clinical evaluation. Results from 24 more patients treated with Radspherin in the RAD-18-002 study are pending.

The Journal of Surgical Oncology publication is available online at: View Source

About the RAD-18-002 Study

RAD-18-002 is a Phase 1/2a open-label study designed to select the clinical dose, and evaluate the safety, tolerability, and signal of efficacy of intraperitoneally administered Radspherin in patients with peritoneal metastases from colorectal cancer scheduled for cytoreduction and HIPEC. The study was closed for recruitment at the end of 2023.

About Radspherin

Radspherin is an investigational radiopharmaceutical designed for the local treatment of cancer that has spread to body cavities. It consists of billions of calcium carbonate microparticles containing the radioactive material radium-224. The mode of action is the decay of radium-224 emitting alpha-particles, a highly potent form of ionizing radiation.

Radspherin is investigated in ongoing clinical studies to treat peritoneal metastases from ovarian and colorectal cancer and it is administered intraperitoneally after surgical resection with removal of all macroscopic tumors.