The Committee for Medicinal Products for Human Use (CHMP), part of the European Medicines Agency, has issued a positive opinion that recommends Opdivo (nivolumab) be approved to treat people with squamous cell cancer of the head and neck (SCCHN) whose disease has progressed on or following platinum-based chemotherapy.
The recommendation will now be reviewed by the European Commission (EC), which has the authority to approve new medicines for the European Union (EU). If its decision is favorable, this newest will be the seventh indication for which Opdivo is approved in the EU.
“Nearly half of all patients with squamous cell cancer of the head and neck relapse within two years of treatment and limited advancements have been made in the last 10 years, underscoring the critical need for new treatment options for patients affected by this devastating illness,” Emmanuel Blin, senior vice president and chief strategy officer, Bristol-Myers Squibb, said in a press release. “We … look forward to working with the EC as they review this treatment as a potential option for patients in the EU.”
CHMP’s positive opinion was based on data from the CheckMate -141, a Phase 3 (NCT02105636) global, open-label, and randomized study to evaluate the safety and efficacy of Opdivo in patients with relapsed or metastatic SCCHN, who progressed following platinum-based chemotherapy.
The trial enrolled 361 patients, who were randomized to receive either Opdivo (240 patients) or investigator’s choice chemotherapy. Chemotherapy treatments included Erbitux (cetuximab), methotrexate, or docetaxel.
Data presented in October at the European Society for Medical Oncology (ESMO) Congress showed that the trial had met its primary endpoint, with Opdivo nearly doubling patients’ one-year overall survival, from 17% in the chemotherapy group to 36% in the Opdivo group.
Median overall survival was also statistically significant and clinically meaningful, with patients in the Opdivo arm living a median of 7.5 months, compared to 5.1 months in the chemotherapy arm. The benefit, however, was particularly higher in HPV-positive cancers (9.1 months vs. 4.4 months).
Results also demonstrated that while patients on the chemotherapy group reported a deterioration in their physical, social, and emotional status, the condition of Opdivo-treated patients remained stable.
Opdivo’s safety profile was consistent with that previously seen in clinical trials for other tumor types.
The U.S. Food and Drug Administration approved Opdivo for SCCHN patients whose disease progressed during or following platinum-based chemotherapy in November 2016 based on these findings.