Immunotherapy Drug Nivolumab Receives FDA Approval for Stage 4 Head and Neck Cancer

On 10 November, for treatment of stage 4 or recurrent squamous head and neck cancers, the United States Food and Drug Administration (FDA) approved an immunotherapy drug called Nivolumab (Opdivo). Squamous cell carcinoma is the commonest cellular type of head and neck cancer (HNC), most frequently in anatomical areas contacting air (such as the mouth, pharynx and larynx). Nivolumab is approved for recurrent or disseminated (metastatic = stage 4) squamous HNC progressing during or after platinum chemotherapy.

The Study

CheckMate 141, a phase-3 clinical trial, led to approval of Nivolumab for HNC. It enrolled patients after standard platinum chemotherapy with recurrent or stage 4 disease: 361 squamous HNC patients. Some received the new-generation cancer immunotherapy Nivolumab until tumor progression/spread (3 mg/kg every 2 weeks) , while others received a clinician-selected standard drug (Cetuximab, Methotrexate or Docetaxel) .

Nivolumab produced better outcomes than standard chemotherapy. The most important result was median overall survival of 7,5 months with Nivolumab versus 5,1 months with chemotherapy.