PEDMARK Shows No Hearing Loss in 15 Adult Head and Neck Cancer Patients
Fennec Pharmaceuticals’ PEDMARK demonstrated safety and practical integration in a multi-institutional retrospective review of 15 head and neck cancer patients receiving PEDMARK ≥6 hours post-cisplatin, with no disruption to treatment delivery. Early data showed most high-risk patients experienced no measurable hearing loss during or after therapy, supporting broader adult use.
1. Study Design and Patient Cohort
A multi-institutional retrospective review assessed 15 adults with head and neck cancers treated with cisplatin followed by PEDMARK at least six hours later. The strict post-cisplatin timing aimed to preserve antitumor activity and mirrored real-world infusion protocols across clinics and home settings.
2. Safety and Feasibility Findings
PEDMARK integration required no changes to curative-intent cisplatin regimens and showed high timing adherence and manageable operational metrics such as infusion chair time. Only isolated, self-limited infusion events occurred and no grade 3 or 4 toxicities were reported.
3. Hearing Preservation Results
Most high-risk patients, including those with baseline hearing impairment, experienced no measurable hearing loss during or after treatment. Early signals of otoprotection suggest PEDMARK may fill a critical survivorship gap in cisplatin-induced hearing loss without compromising efficacy.
4. Implications for PEDMARK Adoption
These findings support potential label expansion into adult head and neck cancers and could drive broader clinical adoption in a sizable patient population at high risk for permanent hearing loss. Further prospective trials and market uptake may enhance Fennec’s growth trajectory.