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Dr. Bourhis on Results of the Phase II Trial With Debio 1143 in Head and Neck Cancer

Jean Bourhis, MD, PhD
Published: Wednesday, Oct 09, 2019



Jean Bourhis, MD, PhD, Radiation Oncology, Centre Hospitalier Universitaire Vaudois, discusses the results of a phase II trial evaluating the addition of Debio 1143 to concurrent high-dose cisplatin and chemoradiation in high-risk patients with locally advanced squamous cell carcinoma of the head and neck.

Data presented at the 2019 ESMO Congress demonstrated that the addition of Debio 1143, a first-in-class oral inhibitor of apoptosis proteins, to standard chemoradiation had a comparable safety profile to standard chemoradiation and placebo in patients with locally advanced head and neck cancer. Adverse events were mostly comparable between arms; however, a higher incidence of grade 3 mucositis, dysphagia, and anemia were reported in the Debio 1143 arm.

At 18 months, investigators reported a 21% improvement in the rate of locoregional control with the addition of Debio 1143 (odds ratio = 2.69; 95% CI, 1.13-6.42; P = .026). Moreover, the median progression-free survival was not yet reached at the time of data cutoff versus 16.9 months in the placebo arm (HR, 0.37; 95% CI, 0.18-0.76; P = .007).
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Jean Bourhis, MD, PhD, Radiation Oncology, Centre Hospitalier Universitaire Vaudois, discusses the results of a phase II trial evaluating the addition of Debio 1143 to concurrent high-dose cisplatin and chemoradiation in high-risk patients with locally advanced squamous cell carcinoma of the head and neck.

Data presented at the 2019 ESMO Congress demonstrated that the addition of Debio 1143, a first-in-class oral inhibitor of apoptosis proteins, to standard chemoradiation had a comparable safety profile to standard chemoradiation and placebo in patients with locally advanced head and neck cancer. Adverse events were mostly comparable between arms; however, a higher incidence of grade 3 mucositis, dysphagia, and anemia were reported in the Debio 1143 arm.

At 18 months, investigators reported a 21% improvement in the rate of locoregional control with the addition of Debio 1143 (odds ratio = 2.69; 95% CI, 1.13-6.42; P = .026). Moreover, the median progression-free survival was not yet reached at the time of data cutoff versus 16.9 months in the placebo arm (HR, 0.37; 95% CI, 0.18-0.76; P = .007).

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