GORTEC, known as the Head and Neck Radiation Oncology Group, today announced that the NIVOPOSTOP GORTEC 2018-01 randomized Phase 3 trial evaluating Nivolumab, Bristol Myers Squibb’s anti-PD-1 therapy, Nivolumab, the anti -PD-1 therapy from Bristol Myers Squibb, as a postoperative treatment component in patients with locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN). high risk of recurrence, met its primary endpoint of disease-free survival (DFS) across all participants.
The study evaluated the addition of nivolumab to standard radiotherapy (SOC) and cisplatin compared to SOC radiotherapy and cisplatin alone after surgery. In a certain number of DFS events, patients receiving nivolumab experienced a statistically significant and clinically meaningful improvement in DFS. The safety profile of nivolumab was consistent with that in previous studies, and compliance with standard treatments was similar in both study arms.
“This is the first time in decades that therapy has demonstrated superiority over standard treatment with cisplatin and radiation therapy in high-risk patients with LA-SCCHN“, said Prof. Jean Bourhis, study leader and medical director of GORTEC.
“These clinically meaningful results have the potential to change practice for high-risk LA-SCCHN patients receiving adjuvant therapy” added both Dr. Yoann Pointreau, President, and Dr. Yun Gan Tao, President-elect of GORTEC.
A trend toward improvement in overall survival (OS), a key secondary endpoint, was observed for nivolumab. Overall survival will be assessed in the final analysis once the predetermined number of deaths has been reached.
Information about GORTEC
GORTEC is a collaborative group dedicated to head and neck oncology. GORTEC has many years of experience with large-scale international innovative Phase III studies, based on solid, high-quality study management and a strong multidisciplinary network of researchers and experts in the field of head and neck cancers.
Information about head and neck cancer
Head and neck cancer includes malignant tumors of the oral cavity, nasopharynx, oropharynx, hypopharynx and larynx and was the sixth most common cancer worldwide in 2022 with 891,453 new cases and 458,107 deaths worldwide*. Most of these cancers are squamous cell carcinoma (SCCHN), and approximately 60% of patients are diagnosed with locally advanced disease (LA). Current treatment guidelines for LA-SCCHN recommend surgical resection followed by radiotherapy or cisplatin radiotherapy (for high-risk pathology after resection). Despite these definitive treatments, a large proportion of LA-SCCHN patients develop locoregional recurrence and/or distant metastases within two years of completion of treatment.
Information about nivolumab
Nivolumab is a programmed death-1 (PD-1) immune checkpoint inhibitor designed to uniquely harness the body’s immune system to restore the anti-tumor immune response. Nivolumab is approved for the treatment of 10 different types of cancer, including colon and rectal cancer, non-small cell lung cancer, head and neck cancer, gastric and gastroesophageal junction cancer, melanoma, esophageal squamous cell carcinoma or adenocarcinoma, mesothelioma, and renal cell carcinoma.
Information about NIVOPOSTOP GORTEC 2018-01
This is a phase 3, randomized, controlled, open-label study (NCT03576417) evaluating nivolumab as adjuvant treatment in patients with resected LA-SCCHN. The main inclusion criteria were high risk of recurrence, defined by nodal extracapsular extension, multiple nodal involvement, multiple peri-neural invasion and/or positive tumor margins after surgery. The primary endpoint was survival, secondary endpoints were OS, quality of life and safety. The study involved 680 patients who were randomized after surgery to receive either standard chemotherapy with 66 Gy of radiotherapy and cisplatin (100 mg/m2 Q3W for three cycles) or nivolumab 240 mg followed by standard chemotherapy with 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, Globale Krebsstatistiken 2022: CA Cancer J Clin 2024; 74(3): 229-63.
Medical contact: Jean Bourhis: jean.bourhis@gortec.fr
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