Fennec to Present Four PEDMARK Otoprotection Studies at ASCO 2026
Four abstracts accepted at ASCO 2026 explore PEDMARK’s efficacy in preventing cisplatin-induced hearing loss: pediatric STS-J01, metastatic GCT Phase 1, young adult tolerability, and head-and-neck audiometric outcomes. PEDMARK is FDA-approved for pediatric use, holds a NCCN 2A adolescent recommendation, and targets ototoxicity affecting 60–90% of cisplatin patients.
1. Abstracts Accepted for ASCO 2026
On April 21, Fennec announced that four PEDMARK® abstracts have been accepted to the American Society of Clinical Oncology Annual Meeting, taking place May 29–June 2 in Chicago. Full abstracts will be available online May 21, with poster sessions on May 31 and June 1.
2. Key Study Details
The accepted abstracts include: Effects of delayed sodium thiosulfate on cisplatin-induced ototoxicity in pediatric patients (STS-J01); a randomized Phase 1 trial in metastatic germ cell tumors; real-world feasibility and tolerability in young adults; and audiometric outcomes for head and neck cancer patients.
3. Regulatory and Clinical Significance
PEDMARK® is the first and only FDA-approved therapy to reduce cisplatin-related ototoxicity in patients one month and older with localized non-metastatic solid tumors. It also carries a National Comprehensive Cancer Network 2A recommendation for adolescent and young adult populations, supported by two Phase 3 trials.
4. Unmet Need and Market Opportunity
Cisplatin-induced hearing loss occurs in 60–90% of treated patients, often requiring lifelong hearing aids or implants. Approximately 500,000 US patients annually receive platinum-based chemotherapy, underscoring strong demand for effective otoprotection.