Nivolumab, Ipilimumab Show Overall Survival Improvements in Squamous Cell Carcinoma of the Head and Neck


Despite a clear trend toward improvement among patients with tumors expressing programmed death-ligand 1, the trial did not meet its primary endpoints.

Updated clinical trial results from the CheckMate-651 trial have found clear overall survival (OS) improvements among patients with squamous cell carcinoma of the head and neck (SCCHN) administered the combination of nivolumab (Opdivo) and ipilimumab (Yervoy). However, the trial did not meet its primary endpoints, according to a press release.

“We are disappointed that these results did not reach statistical significance, and we remain committed to advancing research and supporting patients with this difficult-to-treat cancer,” said Abderrahim Oukessou, MD, vice president of thoracic cancers and development lead at Bristol Myers Squibb, in the press release.

Researchers compared nivolumab plus ipilimumab with the EXTREME regimen of cetuximab, cisplatin or carboplatin, and fluorouracil as a first-line treatment in platinum-eligible patients with recurrent or metastatic SCCHN. The dual primary endpoints of the trial are OS in the intent to treat population and OS in patients whose tumors express programmed death-ligand 1 (PD-L1) with a combined positive score of 20 or greater.

The combination treatment showed a clear, positive trend toward OS among patients whose tumors express PD-L1 but did not meet the primary endpoints. Secondary endpoints include OS among patients with PD-L1-expressing tumors at different cut-off values, objective response rate, duration of response, and progression-free survival in all patients and in those with PD-L1-expressing tumors.

Despite these results, researchers previously found a survival benefit with nivolumab monotherapy in patients with recurrent or metastatic SCCHN following platinum-based therapy in the CheckMate-141 trial. The FDA approved nivolumab for this indication in 2016 based on these findings.

Furthermore, nivolumab plus ipilimumab-based combinations have shown significant improvements in OS in 6 phase 3 clinical trials in 5 different tumors, including non-small cell lung cancer, metastatic melanoma, advanced renal cell carcinoma, malignant pleural mesothelioma, and esophageal squamous cell carcinoma.

“Numerous studies have shown long-term survival improvements with the Opdivo plus Yervoy combination across various tumor types, bringing benefit to patients around the world,” Oukessou said in the press release. “In the CheckMate-651 trial, Opdivo plus Yervoy showed a positive overall survival trend relative to EXTREME in patients with squamous cell carcinoma of the head and neck whose tumors express PD-L1, despite the control arm performing better than expected based on historical data.”


Bristol Myers Squibb provides update on CheckMate-651 trial evaluating Opdivo (nivolumab) plus Yervoy (ipilimumab) versus EXTREME regimen as first-line treatment for squamous cell carcinoma of the head and neck. News release. Bristol Myers Squibb. July 16, 2021. Accessed July 16, 2021.

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