Phase 2 STS-J01 data presented at SIOP 2026 show that Pedmark cut cisplatin-related hearing loss to 24% against a 56.4% historical benchmark, while preserving a 95.8% objective tumor response rate in pediatric and AYA patients. Fennec Pharmaceuticals presented detailed results from the investigator-initiated Phase 2 STS-J01 clinical trial at the 58th Annual International Society of Pediatric Oncology (SIOP) Annual...
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Discussion
Signed responses from readers of the wire.
No immediate practice change for most audiologists; awareness is warranted that Pedmark (already FDA-approved in the US) is showing consistent ototoxicity (medication-related hearing damage) reduction signals in a Japanese Phase 2 trial, which may prompt earlier referral conversations with oncology partners treating pediatric patients.
Pedmark's Japan Phase 2 data reinforce the global case for routine otoprotective co-administration with cisplatin in pediatric oncology, potentially reducing the burden of permanent hearing loss in childhood cancer survivors.
- 01Phase 2 STS-J01 trial data presented at SIOP 2026 for pediatric and AYA patients receiving cisplatin.
- 02Pedmark arm: 24% incidence of significant hearing loss vs 56.4% historical benchmark — a ~57% relative reduction.
- 03Tumor response rate remained high at 95.8%, suggesting Pedmark did not compromise cancer efficacy.
- 04Comparison is to a historical (not concurrent randomized) control, limiting causal certainty.
- 05Pedmark is already FDA-approved in the US; this trial targets Japanese regulatory pathway.
Pedmark reduced cisplatin-related hearing loss to 24% vs a 56.4% historical benchmark in pediatric/AYA patients.
studypartially supportedTumor response rate was 95.8% in patients receiving Pedmark alongside cisplatin.
studypartially supportedPedmark does not compromise cisplatin's anti-tumor effectiveness.
studypartially supported