FDA Grants Fast Track Designation to Radspherin for Peritoneal Carcinomatosis From Ovarian Cancer

The FDA has granted fast track designation to Radspherin for the treatment of patients with peritoneal metastases from ovarian cancer.¹

Positive results from the interim safety analysis of the phase 1/2a RAD-18-001 trial (NCT03732768) indicated that Radspherin was well tolerated and was associated with no dose-limiting toxicities at the recommended dose of 7MBq.

“Fast track designation for Radspherin is a key milestone for Oncoinvent, particularly as we are on the verge of initiating a Phase 2b trial to evaluate Radspherin in peritoneal metastases from ovarian cancer, and later also in peritoneal metastases stemming from colorectal cancer,” Anders Månsson, chief executive officer of Oncoinvent, stated in a press release. “Importantly, this designation reinforces the urgent need for safe and effective therapies for patients suffering from peritoneal metastases. These metastases have a particularly negative impact on life expectancy, and effective treatment therefore has a significant chance of affecting overall survival in these patients. We believe we are well positioned to execute the clinical development of Radspherin in our upcoming trial and look forward to advancing this innovative product candidate to benefit patients battling this type of cancer, for whom there are limited treatment options.”

Radspherin is an innovative alpha-emitting radioactive microparticle suspension intended for localized treatment of metastatic cancers in body cavities. Radspherin involves the instillation of an alpha-radiating microparticle suspension into the targeted body cavity, providing localized radiopharmaceutical therapy without systemic administration. This unique local approach minimizes radiation exposure to healthy tissue, thereby reducing adverse effects.²

Notably, in animal models, Radspherin has been shown to reduce tumor cell growth and increase survival. Additionally, phase 1/2a clinical studies with the agent have demonstrated safety and long-term cancer recurrence prevention.

To have been eligible for the ongoing RAD-18-001 trial, patients must have been 18 years of age or older, had a histologically confirmed diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal carcinoma, had platinum-sensitive recurrences of ovarian carcinoma and been eligible for debulking surgery. Patients also needed to have an ECOG performance score of 0 or 1, as well as adequate renal, hepatic, and bone marrow function.³

Patients with neuroendocrine tumors, non-epithelial ovarian cancers, or tumors of borderline malignancy were excluded from the study. Other exclusion criteria included synchronous visceral metastatic lesions, symptomatic central nervous system metastases, and active infections requiring antibiotics or physician monitoring.

Exclusion extended to patients with active liver disease; those with positive serology for active hepatitis B, hepatitis C, or known HIV; and those who have received an investigational medicinal product within 28 days or at least 5 times the product’s half-life prior to enrollment.

In the first-in-man, dose-escalation study, Radspherin was investigated at increasing dose levels starting at 1 MBq and increasing to 2 MBq, 4 MBq, and 7 MBq in evaluable patients. In the expansion cohort of the study, patients received the recommended dose and are continuing to be followed until disease progression in the abdominal cavity or for 24 months following the administration of Radspherin, whichever comes first.

Following the positive interim safety results with the agent, a phase 2b trial evaluating Radspherin for patients with ovarian cancer is expected to initiate “imminently.” This randomized, controlled phase 2b trial will evaluate the efficacy and safety of Radspherin in patients with peritoneal metastases from ovarian cancer.¹

The primary objective of the upcoming study is to compare progression-free survival outcomes between patients who receive Radspherin after complete surgical resection following pre-operative chemotherapy and those who only undergo pre-operative chemotherapy and surgery.

References

1. Oncoinvent receives FDA fast track designation for Radspherin as treatment for peritoneal carcinomatosis from ovarian cancer. Oncoinvent. June 24, 2024. Accessed July 3, 2024. https://www.oncoinvent.com/press-release/oncoinvent-receives-fda-fast-track-designation-for-radspherin-as-treatment-for-peritoneal-carcinomatosis-from-ovarian-cancer/#:~:text=Oncoinvent%20ASA%2C%20a%20clinical%20stage,with%20peritoneal%20metastases%20from%20ovarian
2. Radspherin. Oncoinvent. Accessed July 3, 2024. https://www.oncoinvent.com/technology/radspherin/
3. Study of Radspherin in recurrent ovarian cancer subjects with peritoneal carcinomatosis. ClinicalTrials.gov. Updated April 5, 2024. Accessed July 3, 2024. https://clinicaltrials.gov/study/NCT03732768