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

Video

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.

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).

Related Videos
Petros Grivas, MD, PhD, professor, Clinical Research Division, Fred Hutchinson Cancer Center; professor, Division of Hematology and Oncology, University of Washington (UW) School of Medicine; clinical director, Genitourinary Cancers Program, UW Medicine
Somedeb Ball, MBBS, assistant professor, medicine, Division of Hematology Oncology, Department of Medicine, Vanderbilt University Medical Center
Phillip J. Koo, MD
Gabriella Smith, MD
Mikkael A. Sekeres, MD, MS
Francesco Di Meo, PhD
Ko Un “Clara” Park, MD
Naseema Gangat, MBBS
Erin Frances Cobain, MD
Pashtoon Murtaza Kasi, MD, MS