FDA approval of Loqtorzi (toripalimab-tpzi) in all lines of treatment for recurrent or metastatic nasopharyngeal carcinoma (NPC).- Coherus Bioscience + Shanghai Junishi.

The approval was based on results of the JUPITER-02 Phase III study and the POLARIS-02 Phase II 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.

In the JUPITER-02 Phase III study, Loqtorzi combined with chemotherapy significantly improved progression-free survival (PFS), reducing the risk of disease progression or death by 48% compared to chemotherapy alone. Loqtorzi also demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS), with treatment resulting in a 37% reduction in the risk of death versus chemotherapy alone. The safety profile of Loqtorzi was consistent with the PD-1 inhibitor class. The incidence of Grade greater than 3 adverse events (AEs) (89.7% vs 90.2%) and fatal AEs (3.4% vs 2.8%) was similar between the two arms. AEs leading to discontinuation of Loqtorzi versus placebo (11.6% vs 4.9%), immune-related adverse events (irAEs) (54.1% vs. 21.7%), and Grade greater than 3 irAEs (9.6% vs. 1.4%) were more frequent in the Loqtorzi arm.

In the POLARIS-02 clinical study Loqtorzi demonstrated durable antitumor activity in patients with recurrent or metastatic NPC who failed previous chemotherapy, with an objective response rate (ORR) of 20.5%, a disease control rate (DCR) of 40.0%, and a median OS of 17.4 months with an acceptable safety profile.

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.