FDA Approves Loqtorzi (toripalimab-tpzi) in All Lines of Treatment for Recurrent or
Metastatic Nasopharyngeal Carcinoma (NPC)
Coherus BioSciences, Inc. and Shanghai Junshi Biosciences Co., Ltd. have announced that the U.S. Food and Drug Administration (FDA) approved Loqtorzi™ (toripalimab-tpzi) in combination with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent locally advanced NPC, and as monotherapy for the treatment of adults with recurrent, unresectable, or metastatic NPC with disease progression on or after platinum containing chemotherapy. The approval was based on results of the JUPITER-02 Phase 3 study and the POLARIS-02 Phase 2 study and is irrespective of a patient’s PD-L1 status. Loqtorzi is a next-generation, programmed death receptor-1 (PD-1) monoclonal antibody that blocks PD-1 ligands PD-L1 and PD L2 with high potency at a unique site on the PD-1 receptor, enabling the immune system to activate and kill the tumor. NPC is an aggressive cancer that starts in the nasopharynx, the upper part of the throat behind the nose and near the base of skull. Due to the location of the primary tumor, surgery is rarely an option, and patients with localized disease are treated primarily with radiation and chemotherapy. Loqtorzi is the first FDA-approved agent for NPC patients.
The recommended Loqtorzi dose with cisplatin and gemcitabine is 240 mg every three weeks until disease progression, unacceptable toxicity, or up to 24 months. The recommended Loqtorzi dose as a single agent for previously treated NPC is 3 mg/kg every two weeks until disease progression or unacceptable toxicity. Loqtorzi is expected to be available in the United States in Q1 2024.
