Toripalimab-tpzi (Loqtorzi) has been approved as the first and only immunotherapy for recurrent, unresectable, or metastatic nasopharyngeal carcinoma (NPC). It can be used in combination with cisplatin and gemcitabine as a first-line treatment for metastatic or recurrent locally advanced NPC, or as a single drug for patients whose disease has progressed after platinum-based chemotherapy.
The approval is based on the phase 3 JUPITER-02 and phase 2 POLARIS-02 trials. Toripalimab, an IgG4 monoclonal antibody, works by blocking the PD-1 pathway to enhance the body’s immune response against tumors.
In the JUPITER-02 study, combining toripalimab with chemotherapy improved progression-free survival (11.7 vs. 8.0 months) and overall survival (not reached vs. 33.7 months), with a higher response rate (77.4% vs. 66.4%) compared to chemotherapy alone. In the POLARIS-02 study, toripalimab alone achieved a 21% response rate, with responses lasting a median of 14.9 months.
Common side effects include immune-related issues such as pneumonitis, colitis, hepatitis, and thyroid problems. The most frequent treatment-related effects were nausea, fatigue, hypothyroidism, and rash