On November 11, 2024 Oncoinvent ASA, a clinical stage company advancing alpha emitter therapy across a variety of solid cancers, reported an interim data readout of the Phase 1/2a studies of Radspherin for the treatment of peritoneal carcinomatoses (Press release, Oncoinvent, NOV 11, 2024, View Source [SID1234648093]). The studies were closed for recruitment at the end of 2023, and patients are currently in long-term follow-up. The readout confirmed the previously published results on efficacy and adds further confidence in the ongoing randomized controlled Phase 2 clinical trial for Radspherin in patients with ovarian cancer.
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In the first interim readout from the Phase 1 study in ovarian cancer, only 1 patient out of the 10 receiving the selected dose (10%) had peritoneal recurrence at the 12-month interim readout, compared to an expected recurrence rate of 25% in similar populations [1-3]. Correspondingly, in the second intermediate readout of the colorectal cancer study, only 3 of 20 patients (15%) receiving the selected dose of 7 MBq had peritoneal recurrence after the full 18 months follow-up period. With current standard therapy, the expected peritoneal recurrence rate is approximately 50% after 18 months [4]. 36 patients with colorectal cancer have received the selected dose, with results from the final 16 patients still pending full follow-up.
"We are excited to announce the interim results of our Phase1/2a studies of Radspherin, confirming a positive efficacy signal and demonstrating Radspherin’s ability to enable local control in the peritoneum, thus ensuring patients remain in remission after surgery," said Oystein Soug, Chief Executive Officer of Oncoinvent. "These positive results increase confidence in the further development of Radspherin as an effective treatment option for patients suffering from peritoneal carcinomatoses, a condition that is notoriously difficult to treat effectively with systemic therapy."
"Patients with ovarian cancer often have peritoneal carcinomatoses already at diagnosis, giving them higher recurrence rate and worse prognosis – so an effective treatment targeted specifically at these carcinomatoses could reduce recurrence and prolong survival," says Yun Wang, MD PhD, Department of Gynecologic Oncology, The Norwegian Radium Hospital, Oslo University Hospital, principal investigator in the RAD-18-001 study.
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 carcinomatoses from ovarian and colorectal cancer and it is administered intraperitoneally after surgical resection with removal of all macroscopic tumors.
About the RAD-18-001 and RAD-18-002 study
Two early phase studies with Radspherin in patients with peritoneal carcinomatoses have completed recruitment at the end of 2023 with 68 patients treated. One study in patients with peritoneal carcinomatoses from platinum sensitive recurrent epithelial ovarian, fallopian tube or primary peritoneal carcinoma (RAD-18-001, n=21, phase 1) scheduled for secondary cytoreduction, and one in patients with peritoneal carcinomatoses from colorectal cancer (RAD-18-002, n=47, phase 1/2a) scheduled for cytoreduction and HIPEC. The two studies were designed to evaluate the dose, safety and tolerability, dosimetry, and signal of efficacy of Radspherin.