Fennec Pharmaceuticals announced positive topline results from the investigator-initiated Phase 2/3 STS-J01 clinical trial in Japan.
The study evaluated PEDMARK for reducing cisplatin-induced ototoxicity in pediatric and adolescent patients with solid tumors.
Results showed a significant reduction in hearing loss in patients who received PEDMARK compared to those receiving cisplatin alone.
Primary Endpoint Met
Significant reduction in hearing loss in 3-18 year old patients with PEDMARK versus historically reported rates with cisplatin alone.
No Interference with Antitumor Activity
Approximately 95% clinical response rate with no interference observed.
Future Plans
Fennec intends to pursue registration and explore partnership opportunities for PEDMARK in Japan based on these results.
- The study demonstrated lower rates of hearing loss in real-world settings in Japan, reinforcing PEDMARK's protective effect.
- Pharmacokinetic analyses showed no reduction in cisplatin exposure and no adverse interaction with antitumor activity.
- Results offer confidence in PEDMARK's efficacy and safety for cancer patients in Japan, addressing an unmet medical need.
The positive results from the STS-J01 study highlight the potential of PEDMARK in reducing cisplatin-induced hearing loss and maintaining antitumor activity. Fennec Pharmaceuticals aims to further advance registration and collaboration opportunities for the drug in Japan.