Grand Pharmaceutical's ITM-11 Phase III Trial Accepted for GEP-NETs in China
核心洞察
Grand Pharmaceutical's ITM-11, a radionuclide-drug conjugate, has its Phase III clinical trial application accepted by China's NMPA.
The trial, named COMPETE Bridging Study, will evaluate ITM-11's efficacy and safety against standard therapy in GEP-NET patients.
ITM-11 targets somatostatin receptors on GEP-NET tumors, offering a potential new treatment option with improved radioisotope purity.
Grand Pharmaceutical Group Limited (搜索) has announced that the National Medical Products Administration (NMPA) of China has accepted its Phase III clinical study application for ITM-11, an innovative radionuclide-drug conjugate (RDC), for the treatment of gastroenteropancreatic neuroendocrine tumors (搜索) (GEP-NETs (搜索)). This acceptance marks a significant step toward providing a new treatment option for patients in China suffering from this increasingly prevalent cancer.
COMPETE Bridging Study Details
The Phase III trial, known as the COMPETE Bridging Study, is designed as a prospective, randomized, controlled, open-label, and multi-center study. It plans to enroll over 60 patients in China to assess the efficacy and safety of ITM-11 Peptide Receptor Radionuclide Therapy (PRRT) compared to standard therapy in patients with inoperable, progressive, Grade 1 or 2, well-differentiated, somatostatin receptor (搜索)-positive (SSTR (搜索)+) GEP-NETs (搜索).
ITM-11: A Targeted Radionuclide Therapy
ITM-11 is a therapeutic RDC drug that utilizes radionuclide conjugated technology to target GEP-NETs (搜索). It combines no-carrier-added 177Lu with a somatostatin analog, selectively binding to somatostatin receptors (SSTR (搜索)) that are highly expressed on the surface of GEP-NET tumors. This targeted approach aims to kill tumor cells while minimizing damage to surrounding healthy tissue. The use of no-carrier-added 177Lu offers higher specific activity and purity compared to commonly used carrier-added 177Lu radioisotope products, potentially reducing long half-life impurities and simplifying radioactive waste handling.
Addressing an Unmet Need in GEP-NET Treatment
According to data from Frost & Sullivan, there were 71,300 newly diagnosed cases of GEP-NETs (搜索) in China in 2020, with incidence rates increasing annually. Current guidelines from the Chinese Society of Clinical Oncology (CSCO) indicate that peptide receptor radionuclide therapy based on 177Lu demonstrates superiority over high-dose octreotide (a somatostatin analogue) in terms of progression-free survival time (PFS) and objective response rate (ORR). ITM-11, along with TOCscan®, another RDC product from Grand Pharmaceutical for GEP-NET diagnosis, aims to provide an integrated diagnostic and therapeutic solution for these patients.
Grand Pharmaceutical's Oncology Strategy
Grand Pharmaceutical is focusing on integrated oncology diagnosis and treatment, with a portfolio of 12 innovative products, including 5 radionuclides (68Ga, 177Lu, 131I, 90Y, and 89Zr) covering 7 cancers (liver, prostate, brain, etc.). The company has 4 innovative RDC drugs approved for clinical research, with 3 in Phase III trials: TLX591-CDx (prostate cancer diagnosis), TLX250-CDx (clear cell renal cell carcinoma diagnosis), and ITM-11 (GEP-NET treatment). The company collaborates with Sirtex Medical, Telix Pharmaceuticals, and ITM Isotope Technologies Munich SE to advance tumor intervention and RDC R&D. They have also partnered with Shandong University to establish a radiopharmaceutical research institute for independent RDC drug R&D.