Fennec Pharmaceuticals has presented real world data supporting the integration of Pedmark into cisplatin-based treatment for adults with head and neck cancer.

The data were shared in a digital poster at the Multidisciplinary Head and Neck Cancers Symposium and are based on a multi-institutional retrospective review of 15 adults with head and neck cancers.

The findings suggest Pedmark (sodium thiosulfate injection) can be administered at least six hours after cisplatin and incorporated into routine care without disrupting curative-intent treatment schedules. The six-hour post-cisplatin interval is designed to preserve cisplatin’s antitumour activity.

According to the review, most high-risk patients who received Pedmark experienced no measurable hearing loss during or after treatment, despite a high prevalence of baseline hearing impairment. No disruption to cisplatin delivery was observed.

Maria Velez, clinical instructor in the division of hematology/oncology at UCLA Health and coauthor of the study, said: “Head and neck cancer is one of the most common cancers globally, underscoring why these results are encouraging for clinicians. Importantly, the data support the potential of the drug to address cisplatin-induced hearing loss – a major and often overlooked survivorship challenge – without compromising cisplatin’s proven antitumor activity.”

Leslie Worona, oncology nurse practitioner at Mount Sinai Hospital and coauthor of the study, added: “Cisplatin-induced hearing loss remains one of the most underrecognized yet deeply consequential toxicities associated with cancer treatment. The findings that most patients – even those with high rates of pre-existing hearing impairment – who received PEDMARK experienced no measurable hearing loss during or after treatment supports further exploration of PEDMARK use in additional patient populations and tumor types such as HNC.”

The primary endpoint of the study was feasibility, defined by adherence to the six-hour timing requirement and operational metrics such as administration setting and infusion chair time. Secondary endpoints included infusion-related events, need for antiemetic escalation and completion of audiology assessments during and after treatment.

Pedmark was reported to be well tolerated in this cohort, with isolated, self-limited infusion events and no grade 3 or 4 toxicities.

Pierre Sayad, chief medical officer of Fennec Pharmaceuticals, said: “These new findings are critical to demonstrating the feasibility, scalability and long-term value of PEDMARK beyond those studied in our pivotal clinical program. Additionally, these data may help to strengthen the case for broader clinical adoption in a sizable patient population at high risk for permanent hearing loss.”

Cisplatin and other platinum-based chemotherapies remain widely used in solid tumours, including head and neck cancer. However, ototoxicity is a recognised adverse effect and can result in permanent hearing loss. Published studies have estimated that between 60% and 90% of patients treated with cisplatin may develop some degree of hearing loss, depending on dose and duration.

Pedmark is approved by FDA to reduce the risk of ototoxicity associated with cisplatin in paediatric patients one month of age and older with localised, non-metastatic solid tumours. It has also received a 2A recommendation from the National Comprehensive Cancer Network for use in adolescent and young adult patients.

The adult head and neck cancer data remain limited to this small retrospective review. The study authors concluded that the feasibility and early hearing preservation signals support further evaluation in broader adult populations treated with cisplatin.

While the presentation focuses on real world feasibility and safety, further prospective data would be required to determine the extent of hearing preservation and confirm that antitumour efficacy is unaffected in larger adult cohorts.