New radiopharmaceutical targeted at gastrointenstinal cancers yields impressive results
A new radiopharmaceutical has the potential to substantially improve outcomes for patients with rare gastrointestinal cancers.
According to ITM Isotope Technologies Munich SE (ITM), its radiopharmaceutical treatment—177Lu-edotreotide, also known as ITM-11—has yielded positive results from its Phase 3 COMPETE trial, which tested the therapy for patients with certain types of gastroenteropancreatic neuroendocrine tumors (GEP-NETs). The study found that the drug significantly extended progression-free survival compared to the current standard treatments for GEP-NETs.
177Lu-edotreotide is a combination of non-carrier-added (n.c.a.) lutetium-177, a therapeutic β-emitting radioisotope, and edotreotide, a somatostatin receptor agonist. In the COMPETE trial, its use was compared to everolimus—an mTOR blocker that is considered the standard of care for GEP-NETs. In the trial, patients were randomized to receive either 7.5 GBq of 177Lu-edotreotide every 3 months for up to 4 cycles, or 10 mg of everolimus daily for up to 30 months, or until disease progression.
As of Jan. 21, the median overall survival was 63.4 months for the 177Lu-edotreotide arm and 58.7 months for the group treated with everolimus. However, median progression-free survival was significantly longer with 177Lu-edotreotide compared to everolimus, at 23.9 versus 14.1 months. What’s more, the drug also was well tolerated, with no patients reporting unexpected treatment-induced adverse reactions.
Study investigator Jaume Capdevila, MD, PhD, senior medical oncologist at Vall d'Hebron University Hospital, Barcelona, presented results this week during the 22nd Annual European Neuroendocrine Tumor Society (ENETS) Conference in Krakow, Poland.
“COMPETE is the first pivotal trial comparing a radiopharmaceutical drug candidate to a targeted molecular therapy without the routine use of accompanying somatostatin analogues in this GEP-NET patient population. These data show unequivocal support for 177Lu-edotreotide's potential benefit in extending PFS,” Capdevila said in the presentation. “Additionally, 177Lu-edotreotide's convenient dosing schedule and favorable safety results reinforce its potential as a compelling new treatment option.”
“These successful results validate our decision to design a pivotal Phase 3 trial directly comparing a targeted radiopharmaceutical against a targeted molecular therapy in Grade 1/2 GEP-NETS, underscoring our commitment to improving the lives of people living with this challenging cancer,” Andrew Cavey, MD, PhD, chief executive officer for ITM, added. “With this successful readout, 177u-edotreotide becomes the first drug candidate in ITM’s broad portfolio of early- to late-stage radiopharmaceuticals to deliver positive Phase 3 results and progress towards NDA submission and commercial launch preparations. 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.”
ITM has plans to submit a New Drug Application with the U.S. Food and Drug Administration later in 2025.
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In addition to her background in journalism, Hannah also has patient-facing experience in clinical settings, having spent more than 12 years working as a registered rad tech. She began covering the medical imaging industry for Innovate Healthcare in 2021.