Insights From: Ezra Cohen, MD, Moores Cancer Center; UC San Diego Health; Jared Weiss, MD, UNC Lineberger Comprehensive Cancer Center
Jared Weiss, MD: CheckMate-141 was an important study, both for nivolumab and for the overall PD-1 and PD-L1 story in head and neck cancer. This study randomized patients with second-line recurrent metastatic head and neck cancer to nivolumab, a PD-1 inhibitor, or to the investigator’s choice of the second-line agents methotrexate, docetaxel, or cetuximab—which are the choices considered in the real world. We now have survival data from that study: improvements from 5 to 7.5 months with the use of nivolumab, with a favorable, but different, toxicity profile—very consistent with the other PD-1 and PD-L1 agents.
What’s unique about this study is that it’s randomized. We have actual randomized data, at least in the second-line setting now, to show the superiority of the PD-1 agent over chemotherapy. This is very analogous to what we already had in the lung cancer situation. As a result of the CheckMate-141 study, nivolumab can be considered a standard second-line agent in recurrent metastatic head and neck cancer.
Ezra Cohen, MD: When we look at anti-PD-1 therapies in comparison to standard therapy, we really have 1 randomized trial to examine. That is the CheckMate-141 trial that compared nivolumab to single-agent standard therapy in patients who are platinum-refractory with recurrent metastatic squamous cell carcinoma of the head and neck. What that study clearly showed was that nivolumab met its primary endpoint—improved survival. In fact, it showed a doubling 1-year survival rate from 17% to 36%, an increased response rate, and an increased median progression-free survival, with a tail on the PFS curve as well. It’s clear, from level 1 evidence, that an anti-PD-1 antibody—in this case, nivolumab—is superior to standard of care in this setting.