Oncoinvent Announces Positive Interim Results from Phase 1/2a Studies of Radspherin

Oncoinvent Announces Positive Interim Results from Phase 1/2a Studies of Radspherin

By, Admin 13 November 2024

Oncoinvent announces positive interim results from phase 1/2a studies of Radspherin for treatment of peritoneal carcinomatosis

Overview

Oncoinvent ASA, a clinical stage company advancing alpha emitter therapy across a variety of solid cancers, announced an interim data readout of the phase 1/2a studies of Radspherin for the treatment of peritoneal carcinomatoses. 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.

1st Interim Outcomes from Phase 1 Study

  • 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. 
  • 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. 
  • 36 patients with colorectal cancer have received the selected dose, with results from the final 16 patients still pending full follow-up.

Words from the CEO: Oncoinvent

  • 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 carcinomatosis, a condition that is notoriously difficult to treat effectively with systemic therapy.

Principal Ivestigator in the RAD-18-001 Study

Patients with ovarian cancer often have peritoneal carcinomatosis already at diagnosis, giving them higher recurrence rate and worse prognosis – so an effective treatment targeted specifically at these carcinomatosis 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 carcinomatosis from ovarian and colorectal cancer and it is administered intraperitoneally after surgical resection with removal of all macroscopic tumours.

Other Studies on Radspherin

  • Two early phase studies with Radspherin in patients with peritoneal carcinomatosis have completed recruitment at the end of 2023 with 68 patients treated. 
  • One study in patients with peritoneal carcinomatosis 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 carcinomatosis 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.

About the Company: Oncoinvent ASA

  • Oncoinvent ASA is a clinical stage, radiopharmaceutical company developing innovative treatments for solid cancers. 
  • The technology platform is focused on the use of alpha-emitting radionuclides to deliver powerful radiation directly to cancer cells.