DebioPharm announced results from a randomized, Phase II study of Debio 1143 for the treatment of high-risk, locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN) patients in combination with the current standard of care, chemo-radiotherapy (CRT). When combined with CRT, Debio 1143 demonstrated significant efficacy – especially in locoregional control rate and progression-free survival. The data were presented at the ESMO Congress (European Society for Medical Oncology).
This double-blind, randomized, control group study enrolled 96 patients with previously untreated stage III, IVA or IVB SCCHN. at 19 centers across France and Switzerland. The majority of patients enrolled were considered high-risk, facing a poor prognosis, including HPV-negative oropharyngeal cancer (OPC) patients and heavy smokers (>10 pack-years). The study explored whether the addition of Debio 1143 at 200 mg/d to standard CRT could increase treatment efficacy compared to CRT and placebo. The primary endpoint of LRC-rate at 18 months was met. 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.
About Debio 1143
Debio 1143 is an antagonist of IAPs (inhibitor of apoptosis proteins), acting as chemo-radio-sensitizer to enhance treatment efficacy with a dual-mode of action, promoting programmed cell death and fostering anti-tumor immunity.
About High-Risk, Locally Advanced Squamous Cell Carcinoma of the Head and Neck
Locally advanced squamous cell carcinoma of the head and neck is a type of skin cancer, which forms in the middle and outer layer of the skin. A subset is diagnosed with a high-risk cutaneous squamous cell carcinoma. High-risk factors include size (>2 cm), thickness/depth of invasion (>4 mm), recurrent lesions, the presence of perineural invasion, location near the parotid gland, and immunosuppression. These patients have a higher risk (>10–20%) of developing metastases to regional lymph nodes.