GORTEC, known as Head and Neck Radiation Oncology Group, today 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. 

About GORTEC

GORTEC is a cooperative group dedicated to Head and Neck Oncology. GORTEC has a long-standing experience of large scale international innovative phase III trials relying on a robust high-quality study management and a strong multidisciplinary network of investigators and experts in the field of head and neck cancers.

About head and neck cancer

Head and neck cancer includes malignancies of the oral cavity, nasopharynx, oropharynx, hypopharynx, and larynx, and is collectively the sixth most common cancer worldwide, having accounted for 891,453 new cases and 458,107 deaths globally in 2022*. Most of these cancers are squamous cell carcinomas (SCCHN), and approximately 60% of patients are diagnosed with locally advanced (LA) disease. Current treatment guidelines for LA-SCCHN recommend surgical resection followed by radiotherapy or cisplatin-radiotherapy (if high-risk pathological findings after resection). Despite these definitive treatments, a large proportion of LA-SCCHN patients develop locoregional recurrence and/or distant metastases within 2 years of completing treatment. 

About nivolumab

Nivolumab is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body's own immune system to help restore anti-tumor immune response. Nivolumab is approved for the treatment of 10 different cancer types including colorectal, non-small cell lung, head and neck, gastric and gastro-esophageal junction cancers, melanoma, esophageal squamous cell carcinoma or adenocarcinoma, mesothelioma, renal cell carcinoma.

About NIVOPOSTOP GORTEC 2018-01

It is a randomized controlled, open-label Phase 3 trial (NCT03576417) evaluating nivolumab as adjuvant treatment in patients with resected LA-SCCHN. The main inclusion criteria were high-risk of relapse as defined by nodal extra capsular extension, multiple nodal involvement, multiple peri-neural invasion and/or positive tumor margins after surgery. The primary endpoint was DFS, and secondary endpoints include OS, QOL and safety. The study enrolled 680 patients who were randomized after surgery to receive either SOC 66 Gy radiotherapy and cisplatin (100 mg/m2 Q3W for three cycles) or nivolumab 240 mg, followed by SOC cisplatin-radiotherapy with nivolumab 360 mg Q3W every 3 weeks during cisplatin-radiotherapy and followed by 6 cycles of nivolumab 480 mg every 4 weeks.

* Bray F, Global cancer statistics 2022: CA Cancer J Clin 2024; 74(3): 229-63.