China—October, 28, 2023, Coherus BioSciences and Junshi Biosciences announced that the US FDA has approved their monoclonal antibody drug, Loqtorzi (toripalimab, also known as TUOYI® or JS001), in combination with gemcitabine and cisplatin, as a first-line treatment for patients with advanced, recurrent or metastatic nasopharyngeal carcinoma (NPC). The drug has also been approved as a monotherapy for the second-line or later treatment of recurrent or metastatic NPC after platinum-containing chemotherapy. According to the press release, toripalimab is the first drug approved by the FDA for the treatment of nasopharyngeal carcinoma.

Toripalimab is a PD-1-targeted monoclonal antibody drug that has shown significant clinical benefits in the JUPITER-02 Phase 3 clinical trial. Compared to chemotherapy alone, toripalimab in combination with chemotherapy significantly improved progression-free survival (PFS) and reduced the risk of disease progression or death by 48% in patients with advanced NPC.

In addition, toripalimab also demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS), reducing the risk of death by 37% compared to chemotherapy alone.

The safety profile of toripalimab was consistent with other PD-1 inhibitor drugs. The incidence of grade 3 or higher adverse events (AEs) (89.7% vs 90.2%) and fatal AEs (3.4% vs 2.8%) was similar between the two groups. However, AEs leading to drug discontinuation (11.6% vs 4.9%), immune-related AEs (54.1% vs 21.7%), and grade 3 or higher immune-related AEs (9.6% vs 1.4%) were more common in the toripalimab group.

In the POLARIS-02 clinical study, toripalimab demonstrated durable anti-tumor activity in patients with recurrent or metastatic NPC who had 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. The safety profile was considered acceptable.