Randomized, double-blind placebo-controlled, Phase 3 study of Debio 1143 in combo with platinum-based chemo and standard fractionation IMRT in patients with locally advanced squamous cell carcinoma of the head and neck, suitable for definitive chemoradiotherapy (TrilynX).
Squamous cell carcinoma of the head and neck (SCCHN) is the 6th most common cancer worldwide. More than half of locally advanced SCCHN (LA-SCCHN) patients will have a tumor relapse or treatment failure within 5 years of treatment.
While surgery can cure some patients, it can also lead to severe limitations in feeding (chewing and swallowing), speaking, and physical appearance leading to social functioning problems and psychological stress. There have been some improvements in surgical technique and radiation delivery in recent years but no innovations that have led to improved care for patients.
The most widely used standard treatment for LA-SCCHN is an IV infusion of cisplatin given every 3 weeks combined with radiation therapy. Although associated with increased toxicity compared to radiotherapy alone, this combination is also associated with increased local control rates and overall survival. Improving SCCHN therapy while maintaining quality of life is a priority.
Debio 1143 is an antagonist of inhibitors of cellular death proteins that has been shown to not only increase the effectiveness of chemoradiation but may also enhance the immune system’s ability to fight cancer. This study is to support the approval of Debio 1143 in untreated LA-SCCHN patients receiving standard of care platinum-based chemoradiation.
This is a Phase 3 (final phase prior to FDA approval) study comparing the efficacy and safety of Debio 1143/placebo when administered in combination with platinum-based chemotherapy and standard fractionation intensity-modulated radiotherapy (IMRT) in previously untreated LA-SCCHN (stage III, IVA, IVB; hypopharynx, larynx and/or HPV-negative OPC).
Placebo controlled studies are used when there is no FDA approved therapy to compare to. Using a placebo does not change the standard of care treatment but helps prevent bias which can adversely influence the results of the study. This study is trying to improve the standard of care therapy by adding Debio 1143.
If you are interested in more information on this study, please contact us. Refer to the study by the title listed above. You can also find information on this study by going to clinicaltrials.gov website and searching for NCT04607668.