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20th April 2023
Nivolumab plus ipilimumab as a first-line treatment for patients with recurrent or metastatic head and neck squamous cell carcinoma (SCC), offers no clinical benefit over nivolumab alone.
Head and neck squamous cell carcinomas (HNSCC) occur in the mouth, pharynx and larynx. Moreover, HNSCC is the sixth most common cancer worldwide, with 890,000 new cases and 450,000 deaths reported in 2018. Prognosis in recurrent or metastatic HNSCC is generally poor with a median survival of 6 to 15 months. Nivolumab and ipilimumab are immune checkpoint inhibitors and nivolumab plus ipilimumab benefits those with advanced melanoma and renal cell carcinoma. Nevertheless, in combination, there was no benefit compared to EXTREME in those with HNSCC.
How each treatment compares alone and in combination for HNSCC is uncertain and was the subject of the current trial. Researchers randomised patients to nivolumab plus ipilimumab compared to nivolumab monotherapy as a first-line treatment for patients with platinum-refractory (PR) or platinum-eligible recurrent (PER) or metastatic HNSCC. The aim was to assess whether combination therapy improved the objective response rate (ORR) compared to nivolumab alone. The trial included adult patients with histologically confirmed recurrent or metastatic HNSCC not amenable to curative therapy. The trial randomised individuals 2:1 (combination vs monotherapy) and the primary endpoint was the ORR.
Nivolumab plus ipilimumab outcomes in HNSCC
The study recruited 425 patients, 241 who were PR and the remainder PER. Among the PR group, the ORR was 13.2% with the combination and 18.3% with nivolumab alone. For PER patients, the ORR was 20.3% with nivolumab plus ipilimumab vs 29.5% with nivolumab monotherapy.
Rates of grade 3 or 4 treatment-related adverse events were similar in both the PR and PER groups.
In their conclusion, the authors commented that the trial did not meet its primary end point of an ORR benefit with first-line nivolumab and ipilimumab vs nivolumab alone.
Harrington KJ et al. Efficacy and Safety of Nivolumab Plus Ipilimumab vs Nivolumab Alone for Treatment of Recurrent or Metastatic Squamous Cell Carcinoma of the Head and NeckThe Phase 2 CheckMate 714 Randomized Clinical Trial. JAMA Oncol 2023