Nivolumab Extended Life in Subset of Head and Neck Cancer Patients Interview with:

Robert L. Ferris, M.D., Ph.D. UPMC Endowed Professor and Vice-Chair Chief, Division of Head and Neck Surgery University of Pittsburgh

Dr. Robert Ferris

Robert L. Ferris, M.D., Ph.D.
Robert L. Ferris, M.D., Ph.D.
UPMC Endowed Professor and Vice-Chair
Associate Director for Translational Research
Co-Leader, Cancer Immunology Program What is the background for this study? What are the main findings?

Dr. Ferris: Investigators at the University of Pittsburgh Cancer Institute<> (UPCI) co-led CheckMate-141<> a large, randomized international phase III clinical trial that 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. Patients were randomized to receive either nivolumab or a single type of standard chemotherapy until tumor progression was observed.

Nivolumab, which belongs to a class of drugs known as immunotherapeutics, enables the body’s immune system to destroy cancer cells. It currently is approved to treat certain types of cancers, including melanoma and lung cancer. The nivolumab group achieved better outcomes than the standard chemotherapy group by all accounts. After 12 months, 36 percent of the nivolumab group was alive, compared to just 17 percent 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 six months of treatment. Importantly, these benefits were achieved with just 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, while those in the chemotherapy group reported a decline. The new trial was considered so successful that it was stopped early to allow patients in the comparison group to receive the new drug. What should readers take away from your report?

Dr. Ferris: These exciting results indicate that there is a new standard of care option for a population of head and neck cancer patients with no other treatment options. What recommendations do you have for future research as a result of this study?

Dr. Ferris: 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. We’re currently working to identify new biomarkers that will allow us to develop a better understanding of how drug resistance develops, and how to best design effective combinations of medications that may improve patient responses. Is there anything else you would like to add?

Dr. Ferris: While 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 percent over the past several decades.

The trial’s other co-chair is Maura Gillison, M.D., Ph.D., from Ohio State University>. Additional U.S. institutions that participated in the trial include University of Texas MD Anderson Cancer Center,Stanford Cancer Institute University of Chicago, University of Michigan, and Dana-Farber Cancer Institute. International collaborators are located at Centre Leon Berard, Centre Antoine Lacassagne, and Institut Gustave Roussy, all in France;Fondazione IRCCS Istituto Nazionale Tumori, in Italy; The Institute of Cancer Research, in the United Kingdom;University Hospital Essen, in Germany; and National Cancer Center Hospital East,and Kobe University Hospital, both in Japan.

The trial was funded by the drug manufacturer, Bristol-Myers Squibb, who is now seeking FDA approval for the use of nivolumab in head and neck carcinoma. Thank you for your contribution to the community.


2016 ASCO abstract:

Further evaluations of nivolumab versus investigator’s choice hemotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck : CheckMate 141.
Abstract No: 6009
J Clin Oncol 34, 2016 (suppl; abstr 6009)
Author(s): Robert L. Ferris, George R. Blumenschein, Jerome Fayette, Joel Guigay, A. Dimitrios Colevas, Lisa F. Licitra, Kevin J. Harrington, Stefan Kasper, Everett E. Vokes, Caroline Even, Francis P. Worden, Robert I. Haddad, Naomi Kiyota, Makoto Tahara, Manish Monga, Mark John Lynch, William J. Geese, Justin Kopit, James W Shaw, Maura L. Gillison; University of Pittsburgh Medical Center Cancer Center, Pittsburgh, PA; The University of Texas MD Anderson Cancer Center, Houston, TX; Centre Léon Bérard, Lyon, France; Centre Antoine-Lacassagne, Nice, France; Stanford Cancer Institute, Palo Alto, CA; IRCCS Istituto Nazionale Tumori, Milan, Italy; Royal Marsden NHS Foundation Trust, London, United Kingdom; University Hospital Essen, Essen, Germany; University of Chicago, Chicago, IL; Institut Gustave Roussy, Villejuif, France; University of Michigan, Ann Arbor, MI; Dana-Farber Cancer Institute, Boston, MA; Kobe University Hospital, Kobe-City, Japan; National Cancer Center Hospital East, Kashiwa, Japan; Bristol-Myers Squibb, Princeton, NJ; The Ohio State University, Columbus, OH

Note: Content is Not intended as medical advice. Please consult your health care provider regarding your specific medical condition and questions.

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Last Updated on June 8, 2016 by Marie Benz MD FAAD