Radionucleotide 177Lu-Edotreotide Receives Fast Track Designation From the FDA for GEP-NETs

Patients with gastroenteropancreatic neuroendocrine tumors may benefit from treatment with radionucleotide therapeutic 177Lu-edotreotide, which received fast track designation from the FDA.

The FDA has granted fast track designation to the radionucleotide therapeutic 177Lu-edotreotide (ITM-11) as a treatment for patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs), according to a press release from ITM Isotope Technologies Munich.

The peptide receptor radionuclide therapy is being assessed in 2 clinical trials: the phase 3 COMPETE study (NCT03049189)—assessing its safety and efficacy in GEP-NETs—and the phase 3 COMPOSE study (NCT04919226) assessing 177Lu-edotreotide in well-differentiated aggressive grade 2/3 GEP-NETs.

“We are dedicated to helping people living with hard-to-treat cancers through our research and development of innovative treatments. Receiving fast track designation provides us the opportunity to work closely with the FDA to optimize and accelerate the final stages of development for ITM-11, bringing our radiotherapeutic [treatment] to patients with GEP-NET as fast as possible,” Steffen Schuster, chief executive officer at ITM, said in a press release.

The agent consists of 2 components, including a medical radioisotope non–carrier-added lutetium-177 and targeting molecule edotreotide, which is a synthetic formulation of peptide hormone somatostatin; this hormone is known to attack neuroendocrine tumor-specific receptors. Edotreotide binds to the receptors and puts lutetium onto the cancerous neuroendocrine cells, thus accumulating at the disease site. The lutetium-177 is then internalized into the cancer cells before decaying and releasing medical radiation up to a radius of 1.7 mm. This destroys the tumor tissue.

The COMPETE study had an actual enrollment of 309 patients who were treated with either 177Lu-edotreotide at a dose of 7.5 ± 0.7 GBq for a maximum of 4 cycles that are 90 days apart or 10 mg of everolimus (Afinitor) per day until disease progression or the end of the study.

The primary end point is progression-free survival (PFS) and the secondary end point is overall survival (OS). Patients were eligible to enroll if they had histologically confirmed disease that was measurable by RECIST criteria, somatostatin receptor (SSTR)–positive disease, or progressive disease. Those who were known to be hypersensitive to edotreotide or everolimus, DOTA, lutetium-177, or any excipient of edotreotide or everolimus were not eligible for treatment.

Moreover, the COMPOSE trial has an estimated enrollment of 202 patients. Patients will be treated with either 177Lu-edotreotide or capecitabine plus temozolomide; everolimus; or folinic acid, fluorouracil, and oxaliplatin. The primary end point was PFS and the secondary end point was OS.

To be eligible, patients were required to have histologically confirmed unresectable, well-differentiated GEP-NETs. Disease needed to be measurable using contrast CT/MRI. Patients also needed to have SSTR-positive GEP-NETs. Those who had previously received peptide receptor radionuclide therapy or treatment with an investigational compound and/or medical device within 30 days of randomization were not eligible to participate.


ITM receives FDA fast track designation for radionuclide therapy candidate ITM-11 (n.c.a. 177Lu-edotreotide) in neuroendocrine tumors (GEP-NETs). News release. ITM Isotope Technologies Munich. October 27, 2022. Accessed October 27, 2022.