ITM's Radiopharmaceutical Drug Outperforms Everolimus in Late-Stage Neuroendocrine Tumor Trial

German biotechnology company ITM (Isotope Technologies Munich) has announced positive results from its Phase 3 Compete study, evaluating the efficacy of its radiopharmaceutical drug ITM-11 against everolimus in patients with inoperable neuroendocrine tumors (NETs) originating in the gut or pancreas.

Trial Results and Implications

ITM-11, a lutetium-177-based therapy targeting the somatostatin receptor, demonstrated a "clinically meaningful and statistically significant benefit" in extending progression-free survival compared to everolimus, a standard chemotherapy treatment. The company reported that the treatment was well-tolerated, although detailed safety data were not disclosed.

The Compete study enrolled 309 patients with inoperable, somatostatin receptor-positive GEP-NETs (gastroenteropancreatic neuroendocrine tumors). Participants received either ITM-11 or everolimus for up to 30 months or until disease progression.

Dr. Jaume Capdevila, a study investigator and senior medical oncologist at Vall d'Hebron University Hospital in Barcelona, emphasized the real-world applicability of the trial, stating, "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."

Market Implications and Competition

ITM-11's success positions it as a direct competitor to Novartis' Lutathera, an approved radiopharmaceutical that also targets the somatostatin receptor using lutetium-177. Former ITM CEO Steffen Schuster, who stepped down on September 1, 2023, previously acknowledged the competitive landscape but expressed optimism about market expansion, noting, "There are so many patients who could get this treatment who don't get treatment."

The positive trial results come at a time of renewed interest and investment in the radiopharmaceutical field. ITM, which both supplies radioisotopes and develops therapies, secured $205 million in funding from private investors in mid-2023, reflecting the growing enthusiasm for this treatment modality.

Next Steps and Future Developments

ITM plans to present the full trial data at an upcoming medical conference and intends to discuss potential approval applications with the U.S. Food and Drug Administration (FDA) this year. The company is also exploring ITM-11's efficacy in other forms of GEP-NETs and in pediatric patients with somatostatin receptor-positive tumors.

As the radiopharmaceutical landscape continues to evolve, the success of ITM-11 in this late-stage trial marks a significant development in the treatment options for patients with rare neuroendocrine tumors, potentially reshaping the standard of care in this challenging therapeutic area.