Nivolumab Approved in Patients With Recurrent SCCHN

The FDA today granted approval to the programmed death ligand-1 inhibitor, nivolumab (Opdivo), for treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN), following platinum-based treatment.

The approval followed results from the phase 3 CheckMate-141 trial, in which nivolumab significantly improved overall survival (OS) compared with the comparator drug. The trial enrolled 361 patients who were randomized to receive either nivolumab (3 mg/kg every 2 weeks) or chemotherapy (either cetuximab, 400 mg/m² once then 250 mg/m² weekly; methotrexate, 40 mg/m² weekly; or docetaxel 30 mg/m² weekly).

The estimated median OS with nivolumab was 7.5 months (95% CI, 5.5-9.1) and 5.1 months for chemotherapy (95% CI, 4-6.0). Serious adverse events were observed in 49% of patients treated with nivolumab, the most frequent being pneumonia, dyspnea, respiratory failure, respiratory tract infection, and sepsis.

“Squamous cell carcinoma of the head and neck that progresses on or after platinum-based therapy is a debilitating and hard-to-treat disease associated with a very poor prognosis,” said Maura Gillison, MD, PhD, lead investigator, Jeg Coughlin Chair of Cancer Research, The Ohio State University Wexner Medical Center, in an associated press release by Bristol-Myers Squibb, the developer of nivolumab. “This latest approval for Opdivo reinforces the potential to provide patients with improved overall survival, considered the gold standard in cancer care.”

Nivolumab has been approved for the treatment of 4 other tumor types.