Immunotherapy With Checkpoint Inhibitors

The U.S. Food and Drug Administration (FDA) approved the anti-PD-1 monoclonal antibody toripalimab-tpzi in combination with cisplatin and gemcitabine for first-line treatment of adults with metastatic or recurrent, locally advanced nasopharyngeal carcinoma. The approval was based on the results of a phase III placebo-controlled clinical trial. Patients received toripalimab-tpzi or placebo in combination with gemcitabine plus cisplatin every 3 weeks for up to six cycles, followed by monotherapy with toripalimab-tpzi or placebo. Patients randomly assigned to receive toripalimab-tpzi had superior PFS and OS rates. The 1-year and 2-year PFS rates were 59.0% versus 32.9% and 44.8% versus 25.4% in the toripalimab-tpzi and placebo groups, respectively. Corresponding OS rates at 2 years were 78.0% versus 65.1%, respectively. At 3 years, the OS rates were 64.5% versus 49.2%, respectively.[22][Level of evidence B1]