Drug Receives FDA's Breakthrough Therapy Status for Treatment of Head, Neck Cancer

The FDA has granted a Breakthrough Therapy designation for Debiopharm’s Debio 1143 for the treatment of patients with confirmed diagnosis of previously untreated, unresectable locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN) in combination with cisplatin-based concomitant standard fractionation chemoradiation therapy (CRT), the current standard of care,.

This is the first newly approved therapy for high risk locally advanced squamous cell carcinoma of LA-SCCHN in 25 years, according to the company.

The Breakthrough Therapy designation was based on the clinical phase 2 study results, NCT02022098, presented at the ESMO Congress 2019 in Barcelona, Spain. Researchers presented a highly significant improvement of the primary endpoint locoregional control rate at 18 months after CRT and a marked Progression-Free Survival benefit versus the CRT+ placebo arm after a 2-year follow-up period.

In addition, Debio 1143 showed a predictable, manageable safety profile that did not compromise the full delivery of standard CRT.

Debio 1143 is a potential first-in-class oral antagonist of inhibitor of apoptosis proteins that sensitizes tumor cells to radio-chemotherapy by promoting programmed cell death, and fostering anti-tumor immunity. Integrating Debio 1143 into the widely used CRT regimen is a promising investigational approach for LA-SCCHN patients over a broad range of cancer types.

Debio 1143 is also being investigated in various solid tumors, along with immune checkpoint inhibitors. An adequate, consistent safety profile has been proven across multiple studies, with over 200 patients being treated with Debio 1143 in various indications and lines of treatment.

REFERENCE

FDA Grants Breakthrough Therapy Designation for Debiopharm's Novel Chemo-Radio Sensitizer Debio 1143 for Front-line Treatment of Head & Neck Cancer [news release]. Lausanne, Switzerland; PR Newswire: February 27, 2020. https://www.prnewswire.com/news-releases/fda-grants-breakthrough-therapy-designation-for-debiopharms-novel-chemo-radio-sensitizer-debio-1143-for-front-line-treatment-of-head--neck-cancer-301012713.html. Accessed February 27, 2020.