The U. S. Food and Drug Administration has approved nivolumab (marketed as Opdivo by Bristol-Myers Squibb) for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after a platinum-based therapy.

Squamous cell carcinoma of the head and neck (SCCHN) accounts for more than 90% of all head and neck cancers, and more than 50% of SCCHN patients present with Stage III or higher disease (locally advanced or metastatic), which has higher potential for progression and recurrence.

The relative five-year survival rate for metastatic head and neck cancers is <38%, and can be as low as 4% for recurrent or metastatic Stage IV disease.

“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, M.D., Ph.D., lead investigator, Jeg Coughlin Chair of Cancer Research, The Ohio State University Wexner Medical Center. “This latest approval for Opdivo reinforces the potential to provide patients with improved overall survival, considered the gold standard in cancer care.”

Approval was based on data from an international, multi-center, open-label, randomised trial (CheckMate 141) comparing nivolumab with investigator’s choice (IC) of chemotherapy (either cetuximab, methotrexate, or docetaxel) in patients with recurrent or metastatic SCCHN with disease progression on or within 6 months of receiving platinum-based chemotherapy.

The trial enrolled 361 patients randomised (2:1) to nivolumab 3 mg/kg every 2 weeks intravenously (IV) (n=240) or IC (n=121) of either cetuximab 400 mg/m2 IV once, then 250 mg/m2 IV weekly (n=15), methotrexate 40 mg/m2 IV weekly (n=52), or docetaxel 30 mg/m2 IV weekly (n=54) until disease progression or unacceptable toxicity.

The trial demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) associated with the nivolumab arm (Hazard Ratio 0.7 [95% CI: 0.52, 0.92]; p=0.0101, stratified log rank test).

Estimated median OS was 7.5 months (95% CI=5.5, 9.1) in the nivolumab arm and 5.1 months (95% CI=4, 6.0) for IC.

Serious adverse reactions occurred in 49% of patients receiving nivolumab.

The most frequent serious adverse reactions reported in at least 2% of patients receiving nivolumab were pneumonia, dyspnea, respiratory failure, respiratory tract infection, and sepsis.

The most common adverse reactions occurring in more than 10% of nivolumab-treated patients and at a higher incidence than IC were cough and dyspnea.

The most common laboratory abnormalities occurring in 10% or more nivolumab-treated patients and at a higher incidence than IC were increased alkaline phosphatase, increased amylase, hypercalcemia, hyperkalemia, and increased TSH.

“With this approval in head and neck cancer, we continue to lead the field in bringing our Immuno-Oncology science and the potential for increasing survival to more people with cancer,” said Chris Boerner, Head of U.S. Commercial, Bristol-Myers Squibb. “We take tremendous pride in the unprecedented speed and rigor with which we have brought Opdivo to market to address unmet needs across more tumor types than any other Immuno-Oncology treatment.”

Sources: FDA and BusinessWire