Background
3-year follow-up results from the randomized phase II study assessing the efficacy and safety of Debio 1143 in combination with chemo-radiation therapy vs. chemo-radiation therapy alone. The treatment was given as front line treatment of high-risk Head and Neck cancer patients which their tumor is locally advanced.
Results
This potential first-in-class drug showed a significant improvement in life expectancy of these patients vs. the control group. Also, suggesting a halving of the risk of death.
In addition, these 3-year follow-up results in 96 patients also confirm the sustainability of the promising 2-year outcomes recently published by demonstrating continued, significant improvements across all other major endpoints including the doubling of the time until the disease stops from responding to the treatment along with superior duration of response.
Side Effects
The predictable and manageable side effects observed with Debio1143 + chemo-radiation therapy at 2 years remained largely unchanged at year 3.
In February 2020, Debio1143 received Breakthrough Therapy Designation from the U.S. Food and Drug Administration, the FDA, reaffirming its potential to offer a significant benefit over the current standard of care in patients with locally advanced Head and Neck cancer.
About Head and Neck Cancer
Cancerous tumors in the Head and Neck area include cancers of the mouth, tongue, pharynx and throat, as well as rare tumors such as cancer of the nose, sinuses, salivary glands and middle ear.
Head & Neck cancer is the 6th most common cancer with a heavy impact on both the life expectancy of high-risk patient types and on patient quality of life, including major dysfunctional impact relative to eating, breathing and talking. There is a high unmet need to develop new drugs for this debilitating cancer type.
About Debio 1143
Debio 1143 is a potential first-in-class oral antagonist of IAPs (inhibitor of apoptosis proteins), that sensitizes tumor cells to radio-chemo therapy.
Over 200 patients have been treated with Debio1143 so far in various indications and lines of treatment, showing an adequate and consistent safety profile across studies.
Conclusions
Debio 1143 in combination with chemo-radiation therapy has the potential to prolong patient lives and achieve better control over their disease.
The best treatment for a cancer patient is to get the most advanced cancer drugs in advanced stages of development. There, the hope and the chance to extend life go far beyond the standard protocols.
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