Bristol-Myers Squibb Company reported new patient-reported quality-of-life data from an exploratory endpoint in the pivotal Phase 3 CheckMate -141 trial evaluating Opdivo in patients with recurrent or metastatic squamous cell carcinoma of the head and neck after platinum therapy compared to investigator’s choice of therapy (methotrexate, docetaxel or cetuximab). Outcome assessments showed Opdivo stabilized patients’ symptoms and functioning, including physical, role, and social functioning across three separate instruments. Both PD-L1 expressors and non-expressors treated with investigator’s choice of therapy experienced statistically significant worsening of patient-reported outcomes from baseline to week 15 versus Opdivo. In addition, Opdivo more than doubled the time to deterioration for most functional domains measured and significantly delayed the time to worsening symptoms of fatigue, dyspnea, and insomnia, compared to investigator’s choice of therapy. 

These findings were presented during a Presidential Symposium at the 2016 European Society for Medical Oncology Congress and will be  published in The New England Journal of Medicine.

“Patients living with this form of advanced head and neck cancer often experience debilitating physiological effects as well as emotional and social challenges brought on by the condition despite current treatment options,” said Kevin Harrington, MD, PhD, Professor in Biological Cancer Therapies at The Institute of Cancer Research, London, and a Consultant Clinical Oncologist at The Royal Marsden NHS Foundation Trust in London. “These patient-reported outcomes are encouraging, as they help us understand the potential for Opdivo to impact important quality-of-life measures for this patient population.”

Squamous cell carcinoma of the head and neck accounts for approximately 90% of all head and neck cancers and may impact a patient’s physiological function (e.g., breathing, swallowing, eating, drinking), personal characteristics (e.g., appearance, speaking, voice), sensory function (e.g., taste, smell, hearing) as well as psychological and social functioning.

John O’Donnell, PhD, MA, vice president, head, Health Economics and Outcomes Research, Bristol-Myers Squibb, commented, “At Bristol-Myers Squibb, we are committed to improving outcomes in advanced cancers and are proud to apply our Immuno-Oncology science to study the way people live with squamous cell carcinoma of the head and neck. The quality-of-life data from CheckMate -141 are important because they provide additional insights into how Opdivo may help patients with this difficult-to-treat disease.”