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ASCO 2016: Nivolumab Immunotherapy Improves Survival, Quality of Life in Metastatic or Recurrent Head and Neck Cancer

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Key Points

  • Patients receiving nivolumab had a 12-month overall survival of 36%, compared with 17% in the standard chemotherapy arm.
  • Nivolumab treatment also doubled the number of patients whose tumors shrunk and the number whose disease had not progressed after 6 months of treatment.
  • Patients receiving nivolumab reported that their quality of life remained stable or improved throughout the study, whereas those in the chemotherapy group reported a decline.

Treatment with nivolumab (Opdivo) doubled overall survival and improved quality of life, with fewer side effects, in a treatment-resistant and rapidly progressing form of head and neck carcinoma, reported a large, randomized international trial co-led by investigators at the University of Pittsburgh Cancer Institute (UPCI). The trial was stopped early to allow patients in the comparison group to receive the study drug.

Findings from the international CheckMate-141 phase III clinical trial were presented by Ferris et al at the 2016 ASCO Annual Meeting in Chicago (Abstract 6009). A subset of the results were previously presented at the American Association for Cancer Research meeting earlier this year. 

“These exciting results indicate there is a new standard of care option for a population of head and neck cancer patients with no other treatment options,” said the trial’s international co-chair Robert Ferris, MD, PhD, Univeristy of Pittsburgh Medical Center Endowed Professor and Chief of the Division of Head and Neck Surgery and co-leader of the Cancer Immunology Program at UPCI.

Study Details

The trial enrolled 361 patients with recurrent or metastatic head and neck squamous cell carcinoma who had not responded to platinum-based chemotherapy, a rapidly progressing form of the disease with an especially poor prognosis, said Dr. Ferris. Patients were randomized to receive either nivolumab or a single type of standard chemotherapy until tumor progression was observed.

The nivolumab group achieved better outcomes than the standard chemotherapy group by all accounts. After 12 months, 36% of the nivolumab group was alive, compared with 17% of the standard chemotherapy group.

Nivolumab treatment also doubled the number of patients whose tumors shrunk and the number whose disease had not progressed after 6 months of treatment. Importantly, these benefits were achieved with one-third the rate of serious adverse events reported in the standard chemotherapy group.

In addition, on average, patients receiving nivolumab reported that their quality of life remained stable or improved throughout the study, whereas those in the chemotherapy group reported a decline.

Although nivolumab improved survival rates in the overall study population, it appeared to be most successful in patients whose tumors were positive for the human papillomavirus (HPV). This is important because the fraction of head and neck cancers attributable to HPV infection has increased by 250% over the past several decades, Dr. Ferris explained.

Next Steps

“Unfortunately, most patients in this trial still experienced a progression of their cancer, demonstrating that we still have a lot of work to do. But, the future appears brighter than ever before because there is a new class of agents, immunotherapies, which we now know can prolong survival and improve quality of life, with few side effects, in head and neck cancer,” said Dr. Ferris.

The research team currently is working to identify new biomarkers that will allow them to develop a better understanding of how drug resistance develops and how best to design effective combinations of medications that may improve patient responses.

The trial was funded by Bristol-Myers Squibb.

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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