ITM Isotope Technologies Munich SE is gearing up to enter the US market with its radiopharmaceutical therapy, ITM-11 (177Lu-edotreotide), after promising Phase III trial results showed a significant advantage over Novartis’s targeted therapy Afinitor (everolimus) in treating gastroenteropancreatic neuroendocrine tumours (GEP-NETs).
The company plans to seek regulatory approval later in 2025 following data from the Phase III COMPETE trial (NCT03049189). The full results were presented at the European Neuroendocrine Tumor Society (ENETS) annual meeting on 6 March in Krakow, Poland. An initial topline announcement on the trial meeting its primary endpoint was made in January 2025.
The COMPETE trial evaluated ITM-11 in direct comparison with Afinitor in 309 patients with inoperable, progressive Grade 1 or 2 somatostatin receptor (SSTR)-positive GEP-NETs. Patients treated with ITM-11 had a median PFS of 23.9 months, compared to 14.1 months for Afinitor. While the interim median overall survival (OS) was numerically higher for ITM-11 at 63.4 months versus 58.7 months for Afinitor, the difference was not statistically significant, with ITM noting that OS data may have been affected by patients switching to alternative therapies after disease progression.
The German company also reported new safety data. In the ITM-11 group, 82.5% of patients experienced treatment-emergent adverse events (TEAEs) compared to 97% of patients taking Afinitor.
Radiopharmaceuticals have gained traction in oncology, particularly for neuroendocrine tumours. Novartis currently markets Lutathera (lutetium Lu 177 dotatate), an approved peptide receptor radionuclide therapy (PRRT) for SSTR-positive GEP-NETs. Sanofi has also entered the space, having partnered with RadioMedix and Qrane Med to develop AlRhaMedix (212Pb-DOTAMTATE), a radioligand therapy for neuroendocrine tumours.
If approved, ITM-11 would compete with Lutathera. Novartis reported Lutathera sales of $724m in 2024, with forecasts projecting revenue growth to $910m by 2030, according to GlobalData’s Pharma Intelligence Center.
GlobalData is the parent company of Pharmaceutical Technology.
The rising interest in radiopharmaceuticals has led to increased investment from major pharmaceutical companies. Sanofi signed a $100m licensing agreement with RadioMedix and Qrane Med in September 2024, following Eli Lilly’s $1.1bn deal with Aktis Oncology in May 2024. AstraZeneca also expanded its radiopharmaceutical portfolio with a $2bn acquisition of Fusion Pharmaceuticals in June 2024.
Despite growing demand, radiopharmaceutical supply chains have faced challenges. There have been shortages of the isotope actinium-225, used in the development of radiopharmaceuticals for treating metastatic castration-resistant prostate cancer (mCRPC), as companies like Novartis, Eli Lilly, and Johnson & Johnson pursue candidates utilising the isotope.
ITM differentiates itself in the competitive landscape by maintaining in-house manufacturing capabilities. “Together, with our global isotopes manufacturing business, robust supply chain, and experienced clinical and commercial team, we believe we are uniquely positioned as a standout leader in the fast-growing radiopharmaceutical industry,” stated ITM’s CEO Andrew Cavey.
In the announcement accompanying the data, Cavey said that the company plans to initiate another pivotal Phase III trial to further compare radiopharmaceuticals with targeted molecular therapies in Grade 1/2 GEP-NETs.
“With this successful readout, 177Lu-edotreotide becomes the first drug candidate in ITM’s broad portfolio of early-to late-stage radiopharmaceuticals to deliver positive Phase III results and progress towards NDA submission and commercial launch preparations,” added Cavey.
