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Latest Data of InnoCare's Zurletrectinib Orally Presented at SIOP 2025
Globenewswire· 2025-10-30 03:51
Core Insights - InnoCare Pharma announced promising data for its next-generation pan-TRK inhibitor zurletrectinib (ICP-723) aimed at treating pediatric and adolescent patients with advanced solid tumors [1][3] Group 1: Clinical Trial Results - The phase I/II clinical trial results were presented at the Congress of International Society of Paediatric Oncology (SIOP) 2025, highlighting the safety, pharmacokinetics, and efficacy of zurletrectinib [2] - Zurletrectinib showed a favorable safety profile and promising antitumor activity in patients with NTRK/ROS1-altered solid tumors, indicating its potential as a next-generation therapy [3] - The predominant tumor types included NTRK-rearranged spindle cell tumors and primary central nervous system tumors [4] Group 2: Dosage and Efficacy - The Recommended Phase 2 Dose (RP2D) was established at 7.2 mg/m² for pediatric patients and 8 mg for adolescents, with pharmacokinetic profiles showing comparable exposure levels between pediatric/adolescent and adult patients [4] - As of July 31, 2025, the objective response rate (ORR) was reported at 90% in NTRK fusion patients, with all patients resistant to first-generation TRK inhibitors achieving partial responses [5] - No dose-limiting toxicities were observed, and treatment-related adverse events were predominantly grade 1-2, further supporting the favorable safety profile of zurletrectinib [5] Group 3: Company Overview - InnoCare is a commercial stage biopharmaceutical company focused on discovering, developing, and commercializing first-in-class and/or best-in-class drugs for cancer and autoimmune diseases with unmet medical needs [6] - The company has established branches in major cities including Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States [6]