Bristol-Myers Squibb announced that their therapy Opdivo (nivolumab) improved health-related quality of life in patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) following platinum chemotherapy, compared to investigator’s choice of therapy (Trexall, Taxotere or Erbitux).
These findings were recently presented at the European Society for Medical Oncology (ESMO) 2016 Congress, and will soon be published in The New England Journal of Medicine.
SCCHN, a disease that accounts for nearly 90 percent of all head and neck cancers, is often associated with debilitating physiological effects, as well as emotional and social challenges.
Patients commonly complain of difficulties in breathing, swallowing, eating, and drinking, and have deteriorated sensory functions, such as taste, smell, and hearing. In addition, these patients may also see their personal characteristics, like their appearance or voice, affected by the disease, which altogether may have severe impacts on their quality of life.
The Phase 3 CheckMate -141 clinical trial assessed the effectiveness of Opdivo compared with other investigators’ choice of therapy: Trexall (methotrexate), Taxotere (docetaxel), or Erbitux (cetuximab). The study included patients with recurrent or metastatic SCCHN with tumor progression within six months of platinum-based chemotherapy.
One of the study’s exploratory endpoints was patient-reported quality-of-life to assess how these treatments affected patients. Quality of life outcomes were measured with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30); EORTC Head and Neck Cancer-Specific Module (EORTC QLQ-H&N35); and the three-level EQ-5D questionnaire (EQ-5D), all of which were self-reported by each patient at the beginning of the study, at week 9, and then six weeks later at the end of the treatment (15 weeks).
Results demonstrated that Opdivo stabilized patients’ symptoms, whereas the other therapies significantly worsened physical, role, and social functioning, as well as fatigue, shortness of breath, and appetite loss.
Also, Opdivo more than doubled the time for global health deterioration, as well as for the loss of physical, role, cognitive, and social functioning compared with the other therapies. Indeed, compared to other therapies, Opdivo significantly decreased the rate of clinically meaningful deterioration in fatigue, insomnia, and shortness of breath by 50 percent, in pain by 74 percent, in sensory problems by 62 percent, and in opening mouth problems by 51 percent.
Overall, these patients experienced stable health status, whereas patients treated with other therapies experienced a worsening of their health status, with a statistically significant difference at 15 weeks.
“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,” Dr. Kevin Harrington, MD, PhD, a professor at The Institute of Cancer Research in London and consultant oncologist at The Royal Marsden NHS Foundation Trust, said in a news release.
“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,” he said.
Opdivo acts upon a protein called programmed death-1 (PD-1), which inhibits the immune system’s ability to detect cancer cells. By inhibiting PD-1, Opdivo restores the body’s capacity to activate the anti-tumor immune response and fight cancer cells. Because of its potential role as an enhancer of the immune system’s response, Opdivo is under evaluation in a broad range of clinical trials across all phases, including Phase 3, in a variety of cancers.
Opdivo is currently approved in more than 57 countries, including the United States, in the European Union, and in Japan.