Swiss-based biopharmaceutical company Debiopharm presented results for its novel IAP antagonist Debio 1143 from phase two trial, for high-risk Head and Neck cancer patients, which met its primary goal of increasing treatment efficacy compared to CRT and placebo.
The study met its primary endpoint of LRC-rate at 18 months, as it explored whether the addition of Debio 1143 at 200 mg/d to standard CRT could increase treatment efficacy compared to CRT and placebo.
For key secondary endpoints, clinically compelling and statistically significant outcomes in Progression-Free survival (PFS) at 24-months were observed along with positive trends for overall survival (OS) and complete response (CR) rates in the active treatment group vs. CRT+placebo, although these parameters have not yet reached statistical maturity, the company said.
“Combined with the standard of care, Debio 1143 has demonstrated significant efficacy – especially in locoregional control rate and progression free survival – in high-risk previously untreated LA-SCCHN patients”, said Pr. Jean Bourhis, Head of the Radio-Oncology Department CHUV, Lausanne, Switzerland, and Lead Investigator of the study. “The chemo-radio-sensitizing effect of Debio 1143 constitutes a highly promising strategy to ultimately allow high-risk head and neck patients to achieve better control over their disease for longer.”
“The positive topline results are very encouraging and support our efforts to provide head and neck cancer patients and clinicians with this potential new treatment option”, said Bertrand Ducrey, CEO of Debiopharm International. “This data demonstrates proof of concept for the potential use of Debio 1143 in other CRT applications,potentially expanding therapeutic reach and making a difference in a wide range of indications.”