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AACR 2016: Nivolumab Improved Survival for Patients With Head and Neck Squamous Cell Carcinoma

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Key Points

  • Patients assigned to nivolumab were found to have a 30% reduction in risk of death compared with those assigned therapy of investigator’s choice. At 12 months, 36% of  patients treated with nivolumab were alive vs 17% of the investigator's-choice group.
  • Median overall survival was 7.5 months for those assigned nivolumab vs 5.1 months for the investigator’s-choice group.
  • Among patients with HPV-positive disease, median overall survival was 9.1 months for those assigned nivolumab vs 4.4 months for those assigned therapy of investigator’s choice; among patients with HPV-negative disease, median overall survival was 7.5 months for those assigned nivolumab vs 5.8 months for those assigned therapy of investigator’s choice.

For the latest information on CheckMate-141, click here, here, or here.

Treatment with the immunotherapeutic nivolumab (Opdivo) improved survival for patients with recurrent or metastatic head and neck squamous cell carcinoma that progressed after platinum-based chemotherapy compared with single-agent chemotherapy of the investigator’s choice, according to results from the CheckMate-141 phase III clinical trial presented by Gillison et al at the 2016 AACR Annual Meeting (Abstract CT099).

“Recurrent or metastatic head and neck squamous cell carcinoma that is not responsive to platinum-based chemotherapy progresses very rapidly, and patients have a very poor prognosis,” said Maura L. Gillison, MD, PhD, a Professor in the Department of Internal Medicine at The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute. “Treatment usually involves single-agent chemotherapy. However, no therapy has been shown to improve survival for this patient population. New treatment options are desperately needed.”

“This study is the first randomized clinical trial to clearly demonstrate improved overall survival for patients with platinum-refractory recurrent or metastatic head and neck squamous cell carcinoma,” continued Dr. Gillison. “We hope that the results will establish nivolumab as a new standard of care option for this patient population and thereby fulfill a huge unmet need.”

Study Findings

CheckMate-141 is a randomized, phase III clinical trial designed to determine whether the programmed cell death protein 1 (PD-1) inhibitor nivolumab could extend overall survival for patients with platinum-refractory recurrent or metastatic head and neck squamous cell carcinoma compared with treatment of the investigator’s choice, ie, any of the commonly used therapeutics docetaxel, methotrexate, or cetuximab.

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

At the interim analysis, which was conducted after 218 events, patients assigned to nivolumab were found to have a 30% reduction in risk of death compared with those assigned therapy of investigator’s choice. Median overall survival was 7.5 months for those assigned nivolumab vs 5.1 months for those assigned therapy of investigator’s choice. At 12 months, 36% of the patients treated with nivolumab were alive compared with 17% of those in the investigator’s-choice group.

Because certain types of head and neck squamous cell carcinoma, particularly those arising in the oropharynx, have been linked with human papillomavirus (HPV) infection, the investigators also evaluated the data based on the HPV status of the patients’ tumors.

The effect of nivolumab on overall survival was seen for both patients with HPV-positive disease and those with HPV-negative disease. Among patients with HPV-positive disease, median overall survival was 9.1 months for those assigned nivolumab vs 4.4 months for those assigned therapy of investigator’s choice; among patients with HPV-negative disease, median overall survival was 7.5 months for those assigned nivolumab vs 5.8 months for those assigned therapy of investigator’s choice.

A survival benefit in patients treated with nivolumab was observed for the overall study population. Exploratory analysis suggested that the benefit was greater for patients treated with nivolumab whose tumors had programmed cell death ligand 1 (PD-L1) expression (of 1% or greater) or were HPV-positive.

“Overall, our data are extremely exciting. This clinical trial has established head and neck squamous cell carcinoma as responsive to immunotherapy. We are hopeful that this represents the tip of the iceberg with regard to future benefit of immunotherapy for patients with head and neck squamous cell carcinoma,” concluded Dr. Gillison.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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