Dr. Bauml Discusses Biomarkers in Head and Neck Cancer

Joshua Bauml, MD, assistant professor, Perelman School of Medicine, University of Pennsylvania, discusses biomarker development for patients with head and neck cancer.

Both pembrolizumab (Keytruda) and nivolumab (Opdivo) are FDA approved for the treatment of patients with head and neck cancer, says Bauml, and are being used in a biomarker-agnostic fashion. The benefit for nivolumab is higher for patients with PD-L1—positive disease.

The FDA granted accelerated approval to pembrolizumab in August 2016 based on the objective response rates (ORR) of the phase Ib KEYNOTE-012 study. The ORR with pembrolizumab was 16% (95% CI, 11%-22%), which included a complete response rate of 5%. Responses lasted for ≥6 months for 82% of patients.

The FDA approved nivolumab in November 2016 based on the CheckMate-141 study. The median overall survival with nivolumab was 7.5 months compared with 5.1 months with investigator’s choice (HR, 0.70; 95% CI, 0.52-0.92; P = .0101). The objective response rate (ORR) was 13.3% with nivolumab and 5.8% for investigator's choice.

According to Bauml, if agents are given in combination, better biomarkers are needed to determine which patients should receive it.