LBA65Double-blind randomized phase II results comparing concurrent high-dose cisplatin chemorradiation (CRT) plus debio 1143 or placebo in high-risk patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN): A GORTEC study

ConclusionsThe primary endpoint was met. LRC rate and PFS significantly improved when Debio 1143 was added to standard CRT in high-risk SCCHN patients. A trend in OS improvement was observed and additional follow-up will provide more mature OS/PFS data. Debio 1143 addition was feasible, safe and did not compromise backbone therapy. These promising results need to be confirmed in a larger phase III study.Clinical trial identificationEudraCT: 2013-000044-25.Editorial acknowledgementMarina Leroy and Berit Sund, from Weber Shandwick.Legal entity responsible for the studyGORTEC group and Debiopharm International SA GORTEC and Debiopharm International SA.FundingDebiopharm International.DisclosureJ. Bourhis: Advisory / Consultancy: Merck; Advisory / Consultancy: MSD; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: BMS. X. Sun: Honoraria (self): Novartis; Honoraria (self): Merck. Y. Pointreau: Honoraria (self), Advisory / Consultancy: BMS; Honoraria (self), Advisory / Consultancy: Merck; Honoraria (self), Advisory / Consultancy: MSD; Advisory / Consultancy: EMD Serono. C. Le Tourneau: Honoraria (self), Advisory / Consultancy: Merck; Honoraria (self), Advisory / Consultancy: Novartis; Advisory / Consultancy: BMS; Advisory / Consultancy: EMD Serono; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: Roche; Advisory / Consultancy: Amgen. A. Coutte: Honoraria (self): Merck; Honoraria (self): Takeda; Honoraria (self): BMS; Honoraria (self): Roche; Honoraria (self): ...
Source: Annals of Oncology - Category: Cancer & Oncology Source Type: research