GORTEC, known as Head and Neck Radiation Oncology Group,  announced that the randomized Phase 3 NIVOPOSTOP GORTEC 2018-01 trial evaluating nivolumab, Bristol Myers Squibb's anti-PD-1 therapy, as a post-operative treatment component for resected patients with locally advanced squamous cell carcinoma of head and neck (LA-SCCHN), with high risk of relapse met its primary endpoint of Disease-Free survival (DFS) across all comers.  

The study evaluated after surgery the addition of nivolumab to standard-of care (SOC) radiotherapy and cisplatin, compared to SOC radiotherapy and cisplatin alone. At a pre-determined number of DFS events, there was a statistically significant and clinically meaningful improvement in DFS for patients receiving nivolumab. The safety profile of nivolumab was consistent with that reported in previous studies, and the compliance to SOC treatments was similar between the 2 arms of the study.

"This is the first time in decades where a therapy demonstrated superiority over standard of care cisplatin-radiotherapy in high-risk patients with LA-SCCHN" said Prof Jean Bourhis, Principal Investigator of the study and Medical Director of the GORTEC.

"These clinically meaningful findings have the potential to be practice-changing for high-risk LA-SCCHN patients receiving adjuvant therapy," added both Dr Yoann Pointreau, President and Dr Yun Gan Tao, President-Elect of the GORTEC.

A trend toward improvement in overall survival (OS), a key secondary endpoint, was observed for nivolumab. OS will be evaluated at the final analysis, once the pre-specified number of deaths has been reached.