Radspherin® Shows Promising 18-Month Results in Ovarian Cancer Trial with 90% Recurrence-Free Rate
Key Insights
Oncoinvent (search)'s Phase 1 trial of Radspherin® demonstrates only 10% recurrence rate at 18-month follow-up in patients with platinum-sensitive recurrent ovarian cancer (search), compared to expected 40% with standard care.
The radiopharmaceutical treatment, administered as a single intraperitoneal dose, shows potential to significantly reduce peritoneal recurrence in ovarian cancer (search) patients with peritoneal carcinomatosis (search).
Based on these promising results, Oncoinvent (search) is advancing Radspherin® to Phase 2 trials, including an ongoing randomized controlled study assessing progression-free survival in ovarian cancer (search) patients with peritoneal metastasis.
Oncoinvent (search) ASA announced encouraging 18-month follow-up data from its Phase 1 clinical trial evaluating Radspherin® in patients with platinum-sensitive recurrent ovarian cancer (search) and peritoneal carcinomatosis (search). The results show that only one out of ten patients (10%) experienced peritoneal recurrence at the 18-month mark, significantly lower than the expected 40% recurrence rate with standard care.
The trial, designated RAD-18-001, administered a single intraperitoneal dose of 7 MBq Radspherin® to ten patients. The company had previously reported 12-month data in November 2024, which showed only one patient with peritoneal recurrence. The 18-month follow-up confirmed no additional recurrences had occurred since then.
Dr. Luis Chiva, Principal Investigator and Director of the Department of Obstetrics and Gynecology at Clinica Universidad de Navarra (search) in Spain, commented on the significance of these findings: "Ovarian cancer (search)'s characteristic peritoneal metastasis lead to frequent recurrences despite a comprehensive treatment approach. I am proud to be part of a study program exploring whether Radspherin® may become a novel therapy that can prevent disease progression, offering hope for a better and longer life for my patients."
Mechanism of Action and Development Status
Radspherin® is an investigational radiopharmaceutical designed specifically for local treatment of cancer that has spread to body cavities. The therapy consists of billions of calcium carbonate microparticles containing radium-224 (search), which emits alpha-particles—a highly potent form of ionizing radiation. In the current trials, Radspherin® is administered intraperitoneally after surgical resection with removal of all macroscopic tumors.
Øystein Soug, CEO of Oncoinvent (search), expressed optimism about the results: "These compelling results underscore Radspherin®'s potential to significantly reduce peritoneal recurrence in ovarian cancer (search) patients. The data not only reinforce our confidence in Radspherin® but also support its advancement in Phase 2 trials, including the ongoing randomized controlled Phase 2 trial assessing progression-free survival in patients with peritoneal metastasis from ovarian cancer."
Clinical Development Program
Oncoinvent (search)'s clinical development program for Radspherin® currently includes one Phase 1 trial, one Phase 1/2a trial, and one randomized Phase 2 trial ongoing across the US, UK, and Europe. The company reports that preliminary clinical efficacy data have been highly encouraging, with no serious toxicity or safety concerns reported to date.
The company has moved up its Quarterly Update from May 27 to April 30 at 11:00 CEST to discuss these promising clinical results, provide operational updates, and share information about the ongoing Phase 2 trial.
Ovarian Cancer and Peritoneal Carcinomatosis
Ovarian cancer (search) is known for its tendency to spread within the peritoneal cavity, leading to peritoneal carcinomatosis (search)—a condition characterized by cancer cells spreading along the peritoneal surfaces. This pattern of spread contributes to the high recurrence rates typically seen in ovarian cancer patients, even after comprehensive treatment approaches including surgery and chemotherapy.
The current standard of care for platinum-sensitive recurrent ovarian cancer (search) with peritoneal carcinomatosis (search) typically involves surgical cytoreduction followed by platinum-based chemotherapy. Despite these interventions, recurrence rates remain high, highlighting the significant unmet need for novel therapies that can effectively prevent disease progression.
About Oncoinvent
Oncoinvent (search) is a clinical-stage biotechnology company focused on developing novel radiopharmaceutical therapies against cancer. The company employs approximately 30 people and operates a state-of-the-art manufacturing facility in Nydalen, Oslo, to produce drug products for clinical trials. Oncoinvent is listed on the Euronext Growth Oslo.
The company's approach with Radspherin® harnesses the benefits of modern radiopharmaceuticals without the complexities of biological targeting, potentially offering a new treatment option for patients with peritoneal metastases from ovarian and colorectal cancers.