KEYNOTE-040 Supports Benefit of Pembrolizumab in Resistant Head and Neck Cancer
Posted: Thursday, January 31, 2019
Evidence was presented in The Lancet to support the use of pembrolizumab in the treatment of recurrent or metastatic head and neck squamous cell carcinoma over standard-of-care therapies with as methotrexate, docetaxel, or cetuximab. The results of the randomized, open-label, phase III KEYNOTE-040 study, performed by Ezra E. W. Cohen, MD, of the San Diego Moores Cancer Center, and colleagues, showed “clinically meaningful prolongation of overall survival” with pembrolizumab monotherapy, particularly in those whose tumors express PD-L1.
Patients enrolled in the study had progressive disease while undergoing platinum-containing treatment or disease progression within 3 to 6 months of completing platinum-containing treatment. A total of 495 patients were selected from 97 medical centers in 20 countries. They were randomly assigned to receive either pembrolizumab (247 patients) or physician’s choice of methotrexate (65 patients), docetaxel (110 patients), or cetuximab (73 patients).
Median overall survival, the primary focus of this study, was 8.4 months with pembrolizumab and 6.9 months with standard chemotherapies. In fact, “the benefit of pembrolizumab compared with standard-of-care therapy was greater in patients with PD-L1 expression on their tumors or in the tumor microenvironment than in those without PD-L1 expression,” they reported.
As for toxicity, grade 3 or greater adverse events were noted in 13% of patients treated with pembrolizumab as compared with 36% of patients treated with standard chemotherapies. For those who received pembrolizumab, the most common treatment-related adverse events was hypothyroidism (13%); for those who received standard chemotherapies, it was fatigue (18%).
“The results of this study solidify the role of PD-1 checkpoint inhibition in the treatment of head and neck squamous cell carcinoma,” concluded the authors. “The large population size and ability to collect tissue samples from the majority of participants helped show that PD-L1 expression is a predictive biomarker in this population.”
Disclosure: The study authors’ disclosure information may be found at thelancet.com.