Sino-Singapore Health丨Innovative drug for the treatment of gastrointestinal and pancreatic neuroendocrine tumors has been approved to begin Phase III clinical research

　　China News Service, Beijing, March 26 (Zhang Yue Zhang Su) The global innovative radionuclide drug conjugate (RDC) ITM-11 for the treatment of gastroenteropancreatic neuroendocrine tumors has recently been approved by the National Medical Products Administration for development. Phase III clinical study (COMPOSE study).

　　Neuroendocrine tumors (NETs) are rare tumors that can occur in many organs and tissues throughout the body, with the digestive system being the most common. Studies have shown that the incidence of GEP-NETs has shown a significant increasing trend in recent years. Due to the insidious onset, atypical symptoms, and high heterogeneity, the diagnosis and treatment of GEP-NETs is difficult and complex.

　　Studies have shown that 177Lu-based peptide receptor radionuclide therapy is superior to the high-dose octreotide (somatostatin analog) currently used in clinical first-line use in terms of progression-free survival (PFS) and objective response rate (ORR). Can bring obvious patient benefits.

　　It is known that compared with the commonly used carrier 177Lu nuclide products, carrier-free 177Lu has higher specific activity and purity, and produces less long half-life impurities and less radioactive pollution during the production process.

　　According to the developer, ITM-11 is an innovative RDC drug based on radionuclide coupling technology for the targeted killing and treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs). There is considerable application space for ITM-11 using carrier-free 177Lu.

　　"ITM-11 has obtained orphan drug qualifications from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA)." A relevant person in charge of Yuanda Pharmaceutical said that the addition of materials for clinical trials in China will greatly promote the development of ITM-11 in China. Register for R&D work.

　　The COMPOSE study approved by ITM-11 this time is a prospective, randomized, controlled, open-label, international multi-center phase III clinical study, aiming to evaluate the drug's efficacy in the treatment of highly differentiated aggressive tumors compared with the best standard treatment. Efficacy, safety, and patient-reported outcomes in patients with grade 2 and 3, somatostatin receptor-positive (SSTR+) GEP-NETs. This study plans to enroll at least 202 patients in more than ten countries around the world. (over)