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Nivolumab Represents New Standard in Recurrent Head and Neck Cancer

Gillison98pxProgrammed death 1 (PD-1) inhibitor treatment with nivolumab significantly improves survival in patients with squamous cell cancer of the head and neck that progresses after platinum-based therapy, according to data from the phase 3 CheckMate-141 trial.

Based on these data, “nivolumab therefore represents a new standard of care option for patients with recurrent/metastatic head and neck cancer after platinum-based therapy,” announced lead investigator Maura L. Gillison, MD, PhD, at the American Association for Cancer Research Annual Meeting.

About 50% of patients with squamous cell carcinoma of the head and neck experience recurrence within 5 years of initial treatment, which includes combinations of surgery, radiation, and platinum-based chemotherapy. Patients who experience recurrence within 6 months of platinum-based therapy have an average survival of ≤6 months. Previously, no anticancer agent had been shown to improve survival in this patient population, and no new treatments have been approved in more than a decade.

CheckMate-141 was a randomized, global, phase 3 clinical trial designed to evaluate nivolumab compared with investigator’s choice single-agent chemotherapy with docetaxel, methotrexate, or cetuximab, which is the current standard of care in this setting. Patients in the trial experienced progression within 6 months of having received platinum-based chemotherapy.

“This was a very heavily pretreated population,” said Dr Gillison, Professor, Department of Internal Medicine, The Ohio State University Comprehensive Cancer Center, Columbus. “Over 90% had previous radiation treatment and 55% had received 2 or more prior lines of systemic chemotherapy for their cancer before enrolling in the trial.”

Of the 361 patients enrolled, 240 were randomly assigned to nivolumab and 121 to single-agent chemotherapy of investigator’s choice.

At an interim analysis performed after 218 events, patients assigned to nivolumab were found to have a 30% reduction in the risk of death compared with those assigned to chemotherapy of investigator’s choice. Median overall survival was 7.5 months for those assigned to nivolumab versus 5.1 months for those assigned to therapy of investigator’s choice (P = .0101).

“What we think is most important about this trial is the proportion of patients who survived to a year; it doubled with nivolumab therapy in comparison to investigator’s choice,” she said. At 1 year, 36% of the patients assigned to nivolumab were alive compared with 17% of those assigned to therapy of investigator’s choice.

The effect of nivolumab on survival was evaluated by PD-1 ligand 1 (PD-L1) expression and human papillomavirus (HPV) status. A survival benefit with nivolumab was observed in patients who had PD-L1 expression ≥1% as well as those with PD-L1 expression <1%, and in patients who were HPV-positive and HPV-negative. “However, the magnitude of the reduction in risk of death was greater for patients whose tumors expressed PD-L1 ≥1% or who were HPV-positive. In those 2 groups, the risk of death was reduced by approximately half.”

Among patients with HPV-positive disease, median overall survival was 9.1 months in the nivolumab arm versus 4.4 months for those assigned to investigator’s choice; among patients with HPV-negative disease, median overall survival was 7.5 months in the nivolumab group versus 5.8 months in the investigator’s choice arm.

No new safety signals emerged with nivolumab treatment in this population. Only 58.9% of patients in the nivolumab arm experienced a treatment-related toxicity, compared with 77.5% in the investigator’s choice arm. There were also fewer grade 3/4 adverse events in the nivolumab arm compared with the investigator’s choice arm.

In patients with recurrent or metastatic squamous cell carcinoma of the head and neck, nivolumab “fulfills an incredible unmet need in the clinic,” said Dr Gillison.

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