Pembrolizumab Immunotherapy Receives FDA Approval for Stage 4. or Recurrent Head and Neck Cancers

The United States Food and Drug Administration (FDA) approved the immunotherapy Pembrolizumab (Keytruda) for head and neck cancer on 5 August. The most common cellular type is squamous cell carcinoma, usually arising in anatomical areas exposed to air, such as the mouth, pharynx and larynx. Pembrolizumab is approved for recurrent or metastatic (stage 4.) squamous head and neck cancer worsening during or after platinum-based chemotherapy.

Immunotherapy drug use in cancer increases daily. First approved in 2014 for the skin cancer melanoma, these drugs subsequently received approval for lung cancer, kidney cancer, Hodgkin lymphoma, bladder cancer and most recently head and neck cancers. There are currently 4 immunotherapy drugs approved for solid organ cancers: ipilimumab (Yervoy), nivolumab (Opdivo), pembrolizumab (Keytruda) and atezolizumab (Tecentriq).

The study leading to approval enrolled 174 head and neck cancer patients, administering every 2 weeks a dose of 10 mg/kg, or every 3 weeks 200 mg. A meaningful response occurred in %16 (objective response rate). Among 28 responders, 23 maintained response for 6 months or longer, up to 27.7 months.

The most common treatment-related side effects were fatigue, appetite loss, breathing difficulty (dyspnea) and hypothyroidism.

Another factor influences head and neck cancer success at least as much as new drugs: an experienced multidisciplinary team! A large study demonstrated this difference, RTOG 0129 (Radiation Therapy Oncology Group). Centers with high participation in head and neck cancer trials had 5-year overall survival of %69, compared with %51 in less experienced centers.