Post-Operative Nivolumab Significantly Improves DFS in Head and Neck Cancer

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The randomized phase 3 NIVOPOSTOP GORTEC 2018-01 trial (NCT03576417) demonstrated that nivolumab (Opdivo) significantly improved disease-free survival (DFS) in resected patients with locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN) at high risk of relapse.¹

The study is evaluating the addition of nivolumab to standard-of care (SOC) radiotherapy and cisplatin after surgery vs SOC radiotherapy and cisplatin alone in patients with LA-SCCHN. At a predetermined number of DFS events, investigators observed a statistically significant and clinically meaningful improvement in DFS for patients receiving nivolumab.

With this, the primary end point of the trial has been met across all patient groups.

"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 Jean Bourhis, professor, principal investigator of the study and medical director of the GORTEC, in a press release.

For safety, nivolumab’s safety profile was similar to that reported in prior studies. Compliance to SOC treatments was consistent between the 2 study arms.

For a key secondary end point, there was a trend toward improvement in overall survival (OS) with nivolumab. When the pre-specified number of deaths has been reached in the study, OS plans to be evaluated at the final analysis.

"These clinically meaningful findings have the potential to be practice-changing for high-risk LA-SCCHN patients receiving adjuvant therapy," added both Yoann Pointreau, MD, president, and Yun Gan Tao, MD, president-elect of the GORTEC, in the press release.

About the NIVOPOSTOP GORTEC 2018-01 Trial

NIVOPOSTOP GORTEC 2018-01 is a phase 3, randomized, controlled, open-label trial where investigators are evaluating the efficacy of nivolumab as adjuvant treatment in patients with resected LA-SCCHN vs radiotherapy and cisplatin alone.²

Enrollment in the trial was open to patients between the ages of 18 and 75 years with resected LA-SCCHN who had an ECOG performance score of 0 or 1 and histologically proven squamous cell carcinoma of the head and neck from the oral cavity, oropharynx, hypopharynx, or larynx. Squamous cell carcinoma of the head and neck must have been treated by primary surgery, Patients must also have had a history of alcohol consumption and smoking, complete macroscopic resection, and be high-risk of relapse as defined by nodal extra capsular extension, multiple nodal involvement, multiple perineural invasion and/or positive tumor margins following surgery.

Patients must also have complete macroscopic resection, must be free of disease, and have recovered from the surgical procedure, allowing for cisplatin-radiotherapy, with radiotherapy planned to start within 4 to 9 weeks after surgery. It is noted that a maximum of 1 additional week could be considered in case of delay due to healing or logistical problems.

In addition to the primary end point of DFS, secondary end points of the study include OS, quality-of-life, and safety.

Overall, a total of 680 patients were enrolled and randomly assigned to receive either SOC 66 Gy radiotherapy and cisplatin at a dose of 100 mg/m² every 3 weeks for 3 cycles after surgery or nivolumab 240 mg, followed by SOC cisplatin and radiotherapy with nivolumab 360 mg every 3 weeks during cisplatin and radiotherapy, followed by 6 cycles of nivolumab 480 mg every 4 weeks.¹

REFERENCES:

1. GORTEC announces new trial success for head and neck cancer treatment. News release. GORTEC. January 7, 2025. Accessed January 8, 2025. https://tinyurl.com/pxwnu7dy

2. A trial evaluating the addition of nivolumab to cisplatin-RT for treatment of cancers of the head and neck (NIVOPOSTOP). ClinicalTrials.gov. Updated July 5, 2024. Accessed January 8, 2025. https://clinicaltrials.gov/study/NCT03576417?tab=table