In a pivotal registrational clinical trial for patients with NTRK fusion-positive solid tumors, zoletrazinib demonstrated efficacy and safety as a broad-spectrum anticancer drug regardless of tumor type. The registrational clinical trial results showed an overall response rate (ORR) of 89.1%, a disease control rate (DCR) of 96.4%, a 24-month progression-free survival (PFS) rate of 77.4%, and a 24-month overall survival (OS) rate of 90.8%.
As a new generation TRK inhibitor independently developed in China, zoletrazinib is more effective than first-generation TRK inhibitors. It not only provides long-term deep remission but also exhibits strong penetrating brain activity and good overall safety. Furthermore, data shows that it can overcome resistance to first-generation TRK inhibitors. The once-daily oral administration of two tablets also offers greater convenience to patients.
Professor Zhang Yizhuo of Sun Yat-sen University Cancer Center believes that NTRK fusion-positive tumors often progress rapidly and have limited treatment options. Zoletratinib has demonstrated remarkable efficacy, particularly in adolescent patients where the overall response rate (ORR) reached 100%. Clinically, zolectratinib's onset of action is significantly faster than traditional chemotherapy, with many patients observing significant tumor shrinkage within one to two cycles, providing a valuable treatment window for critically ill patients. Furthermore, zolectratinib's effective response lasts a long time, with the longest observed response exceeding 36 months, offering hope for longer survival to patients with solid tumors.
Professor Luo Zhiguo of Fudan University Cancer Hospital explained that most of the patients enrolled in his center were sarcoma patients. Zoletrazinib had an overall response rate (ORR) of 89.5% in patients with soft tissue sarcoma, demonstrating excellent efficacy and good safety, enabling patients to use the drug for a long time without affecting their quality of life.
Zolectretinib has been included in the "Pilot Program for Encouraging the Research and Development of Pediatric Anti-tumor Drugs (Starlight Program)" by the National Medical Products Administration. Innovent Biologics expects to submit an NDA application for zolectretinib for the treatment of pediatric patients (aged 2 to 12) soon.

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