Nivolumab OS Data Raise Hopes in Head and Neck Cancer

An international study evaluating the programmed death 1 (PD-1) inhibitor nivolumab in head and neck cancer has found that patients treated with the checkpoint inhibitor were twice as likely to be alive at 1 year after initiating treatment, compared with patients who were in the standard treatment arm of chemotherapy, according to a company press release. This makes nivolumab the first immunotherapeutic agent that can affect outcomes in these patients.

Phase 3 results from the CheckMate-141 trial, sponsored by Bristol-Myers Squibb (the drug developer), were presented at the 2016 annual meeting of the American Association for Cancer Research. The trial was stopped early in January of this year, following review by an independent Data Monitoring Committee that showed nivolumab improved overall survival in squamous cell carcinoma of the head and neck (SCCHN), compared with the control arm.

An open-label, randomized trial, CheckMate-141 was designed to evaluate nivolumab against the investigator’s choice of treatment in patients with recurrent or metastatic SCCHN with tumor progression within 6 months of platinum therapy in the adjuvant, primary, recurrent, or metastatic setting. Patients received either nivolumab or any one of docetaxel, methotrexate, or cetuximab, and the primary end point was overall survival (OS), with secondary endpoints being objective response rate (ORR) and progression-free survival (PFS).

Analysis of the trial results found a 30% reduction in the risk of death in the nivolumab arm, with a median OS of 7.5 months (95% CI, 5.5-9.1) compared with 5.1 months (95% CI, 4.0-6.0) in the control arm (hazard ratio, HR=0.70 [97.73% CI, 0.51-0.96], P=.0101). The 1-year OS was 36% for nivolumab and 16.6% for the control arm. However a correlation with the expression of the programmed death ligand-1 (PD-L1) could not be drawn from the results, because nivolumab was effective overall, independent of the patients’ PD-L1 status.

The trial also evaluated the efficacy of nivolumab in patients who expressed the human papilloma virus (HPV). HPV-positive status was correlated with response to nivolumab—survival was 9.1 months compared with 4.1 months in patients treated with any of the chemotherapy drugs. This difference dropped down to 7.5 months versus 5.8 months, respectively, in HPV-negative patients.

“I’ve been treating head and neck cancer for 20 years, and this is the first time I can reach for something that will be effective in this patient population,” Maura Gillison, MD, PhD, chair of cancer research at Ohio State University in Columbus told Bloomberg. “Average survival is typically less than six months for this group.”