The Munich-based company has confirmed that its prospective, randomised, open-label trial of ITM-11 met its primary endpoint demonstrating a statistically significant benefit in progression-free survival. Image: Shutterstock / Love Employee

ITM Radiopharma’s Phase III trial of its targeted radiotherapeutic for patients with Grade 1 or 2 gastroenteropancreatic neuroendocrine tumours (GEP-NETs) has hit the primary endpoint of prolonging progression-free survival (PFS).

The Munich-based company has confirmed that its prospective, randomised, open-label trial of ITM-11 met its primary endpoint demonstrating a statistically significant benefit in PFS when compared to standard-of-care (SOC) Novartis’ Afinitor (everolimus).

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The company plans to submit data from the Phase III trial as part of a future regulatory submission for approval at some stage this year.

The Phase III COMPETE trial (NCT03049189) also evaluated secondary endpoints, including objective response rate (ORR), overall survival (OS), and quality of life (QoL) assessments, however, these are yet to be fully analysed.

Investigator for the trial, Jaume Capdevila, said: “With COMPETE, this marks the first time that a targeted radiopharmaceutical therapy has demonstrated improved PFS compared to a targeted molecular therapy, Afinitor, in patients with Grade 1 and 2 gastroenteropancreatic neuroendocrine tumours in a Phase III clinical trial.

“The patients included represent a real-life scenario, and the COMPETE study evaluates the important question of which therapy might be used first to provide greater benefit to patients.”

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The trial enrolled 309 patients with Grade 1 or 2 inoperable, progressive, somatostatin receptor-positive neuroendocrine tumours. Patients were randomised to receive ITM-11 with a nephroprotective amino acid solution every three months, or Afinitor 10 mg daily for up to 30 months or until the disease progressed.

Andrew Cavey, CEO of ITM, added: “People with GEP-NETs, whose journey from diagnosis to proper treatment can take years, remain in significant need of more robust, data-driven treatment options to maximize outcomes. The successful COMPETE data support ITM-11’s potential and we believe marks an important milestone for patients and for ITM.”

The news follows after the company aired concerns that whilst the radiotherapeutics space is set to grow, red tape and industry complexities are holding progress in the space back. Meanwhile, Austrian competitor Telix Pharmaceuticals has announced a 55% year-on-year revenue increase in 2024.