Pharma Focus America

Oncoinvent Secures FDA Approval for Investigational New Drug (IND) Application for Radspherin® in Colorectal Cancer Treatment

Saturday, October 28, 2023

Oncoinvent AS, a clinical-stage company specializing in alpha emitter therapy for various solid cancers, has received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application. This clearance pertains to a phase 2b study of Radspherin® in patients suffering from peritoneal carcinomatosis due to colorectal cancer.

Oncoinvent, expressed his enthusiasm about this IND clearance, which comes on the heels of promising safety and efficacy data from the RAD-18-002 Phase 1/2a clinical trial. He views this as an important milestone for Oncoinvent, enabling them to advance Radspherin® clinically in the United States. The positive clinical data further strengthens their belief in Radspherin's potential, and they look forward to progressing its clinical development.

In the ongoing phase 1/2a clinical trials with Radspherin®, all dose levels have been well-tolerated, with a recommended dose of 7MBq. Recently, Oncoinvent presented preliminary 18-month safety and efficacy data from the RAD-18-002 study at the 13th International Congress on Peritoneal Surface Malignancies (PSOGI). Notably, none of the 12 patients who received the recommended dose of 7 MBq experienced peritoneal recurrences, and adverse events related to Radspherin® were minimal, with all being grade 1-2.

The upcoming trial, for which FDA clearance has been obtained, will be a randomized controlled phase 2b study. It will evaluate the efficacy and safety of Radspherin® in patients with peritoneal carcinomatosis resulting from colorectal carcinoma following cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC). The primary objective of this trial, slated to commence in the second quarter of 2024, is to compare progression-free survival (PFS) between patients who undergo CRS and HIPEC with those who receive Radspherin® in addition to CRS and HIPEC.



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