Fennec to Unveil Four PEDMARK Studies at ASCO Showing Hearing Loss Rates Reduced from 56–63% to 16–24%
The 2026 ASCO Meeting will feature four PEDMARK studies from Fennec Pharmaceuticals, highlighted by a Phase 2/3 Japanese trial reducing hearing loss from 56–63% to 16–24% in 27 AYA patients. Retrospective series in nine young adults and 15 head-and-neck patients show safe ≥6-hour delayed dosing maintains antitumor activity.
1. ASCO Presentation Overview
Fennec Pharmaceuticals will present four independent studies at the 2026 ASCO Annual Meeting evaluating PEDMARK’s integration with cisplatin chemotherapy to prevent cisplatin-induced ototoxicity across pediatric, adolescent and young adult, and adult cancer patients, building on FDA approval for pediatric use and NCCN 2A recommendation for AYA patients.
2. Phase 1 Metastatic Germ Cell Tumor Trial
The randomized Phase 1 trial in metastatic germ cell tumor survivors, opened to accrual in January 2026, will assess safety and efficacy of cisplatin with or without PEDMARK in men with GCT, where approximately 75% of adult survivors develop cumulative cisplatin-associated hearing loss.
3. STS-J01 Phase 2/3 Japanese Trial
The investigator-initiated Phase 2/3 STS-J01 trial in Japan enrolled 27 pediatric and AYA patients with non-metastatic solid tumors and met its primary endpoint, reducing hearing loss incidence from 56–63% to 16–24% with PEDMARK administration compared to historical cisplatin-only rates.
4. Real-World Adult Feasibility Data
Retrospective analyses include a nine-patient case series in young adults demonstrating feasible integration of PEDMARK without affecting cisplatin’s antitumor activity, and a multi-institutional review of 15 head-and-neck cancer patients showing safe ≥6-hour delayed dosing preserves clinically significant hearing.