Fennec Pharmaceuticals to Present New PEDMARK® Research at ASCO
Fennec Pharmaceuticals announced that new research evaluating PEDMARK® (sodium thiosulfate injection) will be shared at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. These four independently led studies expand the understanding of PEDMARK's clinical utility in Adolescent and Young Adult (AYA) and adult populations, building upon its established safety and efficacy in pediatric patients. The research includes a Phase 1 trial design for metastatic germ cell tumors, detailed results from a Japanese Phase 2/3 trial showing significant reduction in hearing loss, and real-world evidence demonstrating feasibility and hearing preservation in AYA and adult patients with various solid tumors.
Key Highlights
- New research on PEDMARK® (sodium thiosulfate injection) to be presented at the 2026 ASCO Annual Meeting.
- Phase 1 trial design for metastatic germ cell tumor in adult men opened to accrual by City of Hope.
- Japanese STS-J01 Phase 2/3 trial showed 16-24% hearing loss with PEDMARK® vs 56-63% historically in pediatric/AYA patients.
- Real-world evidence shows PEDMARK® is safe and does not compromise cisplatin's antitumor activity in AYA/adults.
- Real-world data in 15 adults with head and neck cancers showed PEDMARK® preserved clinically significant hearing.
- PEDMARK® is FDA-approved for pediatric patients 1 month and older with localized, non-metastatic solid tumors.
- NCCN provides a 2A recommendation for PEDMARK® use in adolescent and young adult patients.
Price Impact
More from FENC