Toripalimab – PD-1 Inhibitor
Boosting the body’s immune response against cancer.
Toripalimab-tpzi is a next-generation anti-PD-1 monoclonal antibody that blocks PD-L1 binding to the PD-1 receptor at a unique site with high affinity and activates antitumor immunity demonstrating, in clinical trials, improvement in the overall survival of cancer patients in several tumor types.
On October 27, 2023, 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 nasopharyngeal carcinoma (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.
Toripalimab-tpzi is a next-generation anti-PD-1 monoclonal antibody that targets cancer by blocking a specific interaction, revving up the immune system, and potentially improving overall survival across various cancers.
Ongoing Clinical Development
Toripalimab-tpzi is the foundation of Coherus’ immuno-oncology pipeline which includes multiple antibody immunotherapy candidates focused on enhancing the innate and adaptive immune responses to enable a robust immunologic response and enhance outcomes for patients with cancer. We are currently exploring toripalimab-tpzi in combination with our TIGIT targeted antibody, CHS-006, and plan to explore toripalimab-tpzi combinations with other candidates in our portfolio including casdozokitug and CHS114.
Casdozokitug is a first-in-class anti-IL-27 antibody currently being evaluated in two on-going clinical studies: a Phase 1/2 study in advanced solid tumors including in combination with toripalimab-tpzi in NSCLC and a Phase 2 study in hepatocellular carcinoma. CHS-114 is a highly selective, anti-CCR8 antibody currently in a Phase 1/2 study as a single agent in patients with advanced solid tumors and is planned to be evaluated in combination with toripalimab for the treatment of head and neck cancer.
More than 40 company-sponsored toripalimab clinical studies covering over 15 indications have been conducted globally by our partner Junshi Biosciences, including in China, the United States, Southeast Asia, and European countries. Ongoing or completed pivotal clinical trials evaluating the safety and efficacy of toripalimab cover a broad range of tumor types, including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney, and skin.