Cisplatin reliably kills pediatric tumors and reliably damages hearing, and the question hanging over PEDMARK has always been whether hearing protection comes at the cost of antitumor effect. Data from the investigator-initiated Phase 2 STS-J01 study, presented September 17 at the SIOP Annual Meeting in San Antonio, answer that directly: the trial met its primary endpoint, showing significant hearing protection with no evidence that sodium thiosulfate interfered with cisplatin’s cancer-killing activity in Japanese pediatric and adolescent patients with non-metastatic solid tumors.
That finding matters beyond Japan. PEDMARK earned FDA approval in September 2022 for reducing cisplatin-associated ototoxicity in patients one month of age and older with localized, non-metastatic solid tumors, but physician adoption anywhere depends on confidence that otoprotection does not blunt chemotherapy. Oncologists treating children with cisplatin-based regimens have historically faced an uncomfortable trade-off, and STS-J01 adds a prospective data point, in a distinct patient population, that the two goals are not in conflict.
The Japan-specific context also carries regulatory weight. STS-J01 is an investigator-initiated study, not a Fennec-sponsored trial, which means it was designed and run by local clinicians with direct interest in the question for their own prescribing environment. A positive result from that kind of study typically carries credibility with national regulators and formulary committees that might otherwise wait for a company-sponsored dossier. For Fennec, a favorable outcome it did not have to run is a useful asset as it pursues market access outside the United States.
The 8-K furnishes the press release as an exhibit rather than incorporating the full dataset, so granular numbers on patient counts, hearing-loss grading, and tumor response rates are not in the filing itself. What Fennec filed is essentially a regulatory disclosure that positive data exist and were announced publicly. The measure to track now is whether STS-J01’s results accelerate a Japanese regulatory submission, since a positive local study without a filing pathway converts to access for patients only on paper.
Source link: https://www.sec.gov/Archives/edgar/data/1211583/000110465926108565/fencf-20260917x8k.htm
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
