Debio 1143 ups survival of high-risk head & neck cancer patients

August 15, 2020 0 By FM

Debio 1143, an oral first-in-class inhibitor of apoptosis proteins (IAPs) antagonist was found to significantly improve the overall survival (OS) when combined with chemo-radiation therapy (CRT) in patients with high-risk locally advanced squamous cell cancer of the head and neck (LA-SCCHN), announced the global biopharmaceutical company, Debiopharm.

Debio 1143 is a potent, inhibitor of IAPs that displays immunomodulatory properties making it a natural candidate for combination with immune checkpoint inhibitors. In addition, like other members of the class, Debio 1143 also promotes apoptosis of cancer cells by mimicking the activity of the natural Second Mitochondrial-derived Activator of Caspases (SMAC).

The findings of a 3-year follow-up from the randomised phase II study assessing the efficacy and safety of Debio 1143 in combination with CRT vs. CRT alone for the treatment of high-risk LA-SCCHN patients were published in the journal The Lancet.

The study showed that when combined with CRT, Debio 1143 showed a statistically and clinically significant improvement in overall survival (OS) vs. the control group, suggesting a halving of the risk of mortality (p=0.0261).

The 3-year follow-up results in 96 LA-SCCHN patients also confirmed the sustainability of the promising 2-year outcomes by demonstrating continued, statistically significant improvements across all other major endpoints including the doubling of the progression-free survival rate along with a superior duration of response, revealed the company.

The study treatments were administered over three 3-week cycles at study initiation. The predictable and manageable safety profile observed with Debio 1143 + CRT at 2 years remained largely unchanged at year 3.

“These 3-year follow-up results could have major implications for high-risk head & neck cancer patients, especially those with negative HPV status who appear to be associated with the poorest prognosis. As the compound is now advancing into phase III, we will be able to gather further evidence for this radio-chemo enhancing IAP antagonist that has the potential to become a standard-of-care treatment for radiation oncology,” said Prof. Jean Bourhis, Department Head of Radio-Oncology at the University Hospital of Lausanne and Lead Investigator of the study.