Trial of nivolumab plus ipilimumab for first-line HNSCC misses primary endpoints
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A phase 3 trial of nivolumab plus ipilimumab vs. the EXTREME regimen as first-line treatment of advanced squamous cell carcinoma of the head and neck failed to meet its primary endpoints of OS, according to a company-issued press release.
The randomized, multicenter CheckMate-651 study evaluated the combination of nivolumab (Opdivo, Bristol Myers Squibb), a PD-1 immune checkpoint inhibitor, and ipilimumab (Yervoy, Bristol Myers Squibb), which targets CTLA-4, against EXTREME, which consists of cetuximab (Erbitux; ImClone, Eli Lilly), cisplatin/carboplatin and fluorouracil, among platinum-eligible patients with recurrent or metastatic HNSCC.
OS among the intent-to-treat population and among patients with a combined positive score of 20 or greater for tumor PD-L1 expression served as dual primary endpoints. OS among patients with various levels of tumor PD-L1 expression, objective response rate, duration of response and PFS served as secondary endpoints.
The immunotherapy combination showed a positive trend toward improved OS among all patients and among those in the PD-L1 subset; however, the study did not achieve its primary endpoints, according to the press release.
“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,” Abderrahim Oukessou, MD, vice president of thoracic cancers and development lead for Bristol Myers Squibb, said in the release. “In the CheckMate -651 trial, Opdivo plus Yervoy showed a positive OS 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. 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.”
Opdivo received FDA approval in 2016 for adults with recurrent or metastatic HNSCC following platinum-based chemotherapy.
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