Oncoinvent, a clinical-stage company focused on solid cancers, has reported positive 18-month safety and efficacy data on Radspherin for colorectal cancer from a Phase 1/2a study.
According to the findings, Radspherin is well tolerated after cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (HIPEC).
Radspherin is an investigational radiopharmaceutical aimed at locally treating cancer that has metastasized to body cavities.
In October 2023, the US Food and Drug Administration (FDA) granted clearance of an investigational new drug (IND) application for the Phase 2b study of Radspherin in colorectal cancer patients.
The Phase 1/2a study results, published in the Journal of Surgical Oncology, highlighted data from 23 patients enrolled in the Phase 1 part of the RAD-18-002 study involving colorectal cancer patients.
RAD-18-002 is a Phase 1/2a open-label study that aims to determine the optimal clinical dose and assess the safety, tolerability, and efficacy of intraperitoneally administered investigational radiopharmaceutical.
Recruitment for the study concluded at the end of 2023.
At 18 months, no patients receiving the recommended dose experienced peritoneal recurrences.
Additionally, the investigational radiopharmaceutical demonstrated promising efficacy signals, indicating a need for further clinical evaluation.
Results from 24 more patients in the RAD-18-002 study are forthcoming.
In June 2023, Oncoinvent presented 15-month safety and efficacy data for Radspherin in colorectal cancer.
Oncoinvent scientific advisory board co-founder and member Emeritus Oyvind Bruland said: “We are pleased to see our data published in such a well-recognized scientific journal.
“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.”
The investigational radiopharmaceutical is also being investigated in ongoing clinical studies for treating peritoneal metastases from ovarian and colorectal cancer.
Last month, Oncoinvent dosed the first patient in its Phase 2 study of Radspherin for peritoneal carcinomatosis from ovarian cancer.
This randomised controlled trial aims to evaluate progression-free survival in patients receiving Radspherin after complete surgical resection and pre-operative chemotherapy.
