Coherus BioSciences, Inc. and Shanghai Junshi Biosciences Co., Ltd. have disclosed that the U.S. FDA has approved LOQTORZI™ (toripalimab-tpzi). This drug is sanctioned for use in combination with cisplatin and gemcitabine as an initial line of treatment for adults with either metastatic or recurrent locally advanced NPC (Nasopharyngeal Carcinoma). It is also approved as a monotherapy for adults who have recurrent, unresectable, or metastatic NPC and have experienced disease progression following platinum-based chemotherapy.
The approval was based on the findings from the JUPITER-02 Phase 3 and POLARIS-02 Phase 2 clinical trials. LOQTORZI is a programmed death receptor-1 (PD-1) monoclonal antibody that obstructs PD-1 ligands PD-L1 and PD-L2 effectively by binding to a unique site on the PD-1 receptor. This action helps to mobilize the immune system to identify and eliminate tumor cells.
Denny Lanfear, the Chairman and CEO of Coherus, described this first approval of LOQTORZI as a watershed moment for the company, positioning it as a leader in innovative cancer treatments. Lanfear emphasized the company’s eagerness to expand the applications of LOQTORZI to treat various types of cancer. This would be done in conjunction with other I-O (immuno-oncology) agents designed to target the tumor microenvironment, like their IL27-targeted antibody, casdozokitug, and their CCR8 inhibitor CHS-114.
Source: Coherus and Junshi Biosciences Announce FDA Approval of LOQTORZI™ (toripalimab-tpzi) in All Lines of Treatment for Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC).
https://www.globenewswire.com/news-release/2023/10/27/2768663/0/en/Coherus-and-Junshi-Biosciences-Announce-FDA-Approval-of-LOQTORZI-toripalimab-tpzi-in-All-Lines-of-Treatment-for-Recurrent-or-Metastatic-Nasopharyngeal-Carcinoma-NPC.html
