Opdivo (nivolumab) has been approved in Europe to treat patients with squamous cell cancer of the head and neck (SCCHN) whose disease has progressed while on, or following, platinum-based chemotherapy.
“The European Commission’s approval of Opdivo marks not only the first new treatment option in 10 years for patients with advanced cancers of the head and neck, but also the first Immuno-Oncology treatment for SCCHN,” Murdo Gordon, executive vice president and chief commercial officer with Bristol-Myers Squibb, the treatment’s developer, said in a press release. “Bristol-Myers Squibb remains committed to redefining survival for patients with cancer, and now that Opdivo is approved in Europe, we will work collaboratively with EU health authorities to ensure it is available for these patients as quickly as possible,” Gordon said.
The approval by European Commission (EC) follows the positive recommendation of the Committee for Medicinal Products for Human Use (CHMP) in March, and was based on data from CheckMate-141, a global and open-label Phase 3 clinical trial (NCT02105636) that assessed the effectiveness and safety of Opdivo in 361 patients with relapsed or metastatic SCCHN, who progressed following platinum-based chemotherapy. Patients in the trial were assigned randomly to treatment with either Opdivo (240 patients) or investigator’s choice chemotherapy (Erbitux [cetuximab], methotrexate, or docetaxel).
Interim results showed the study met its primary goal, with Opdivo demonstrating statistically significant improvements in overall survival — a 30% reduction in the risk of death in Opdivo-treated patients, and a median overall survival of 7.5 months in this group, compared to 5.1 months in chemotherapy group, the company stated in its press release. There were no statistically significant differences in progression-free survival and objective response rate among the two groups. Early results also were published in The New England Journal of Medicine in November 2016.
Patient-reported quality-of-life outcomes recorded a decline in physical, social and emotional status among those in the chemotherapy group, while these outcomes in people treated with Opdivo were seen as stable.
Opdivo’s safety profile was consistent with that reported in previous clinical studies for non-small cell lung cancer and melanoma, two cancers for which Opdivo is an FDA-approved treatment. Serious adverse events occurred in 49% of Opdivo-treated patients, and included respiratory failure, respiratory tract infection, dyspnea, pneumonia, aspiration pneumonia, and sepsis.
“Adult patients with squamous cell cancer of the head and neck that progresses on or after platinum-based therapy are fighting a debilitating and hard-to-treat disease that is associated with a very poor prognosis,”said Kevin Harrington, MD, a professor in Biological Cancer Therapies at The Institute of Cancer Research, and a consultant clinical oncologist at The Royal Marsden NHS Foundation Trust, both in London. “As an oncologist who helps patients deal with this terrible disease, I hope that nivolumab will now be made available as widely as possible, offering this group of patients a new treatment option that can potentially improve their overall survival.”
The National Institute for Health and Care Excellence (NICE), however, recommended against Opdivo in April, meaning the treatment likely will not be available for people with head and neck cancers in the U.K. under the country’s National Health Service (NHS). NICE, in its opinion, agreed that Opdivo provided a significant improvement in short-term survival when used as a second-line treatment after chemotherapy, but found its cost too high for the NHS given its “uncertain” long-term survival and life quality benefits. A final decision is expected soon.