Shanghai Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) has announced receiving marketing approval from the Singapore Health Sciences Authority (HSA) for its Loqtorzi (toripalimab). The anti-PD-1 monoclonal antibody (mAb) is approved for use in combination with cisplatin and gemcitabine as a first-line treatment for recurrent, not amenable to surgery or radiotherapy, or metastatic nasopharyngeal carcinoma (NPC). This makes toripalimab the first and only approved immuno-oncology treatment for NPC in Singapore.
Clinical Trial Results
The HSA approval is based on results from the randomized, double-blinded, placebo-controlled, global multi-center Phase III JUPITER-02 study. The study demonstrated that the toripalimab/chemotherapy combination reduced the risk of disease progression by 48% and death by 37% compared to chemotherapy alone. Progression-free survival was significantly prolonged (median PFS: 21.4 months vs. 8.2 months), and no new safety signals were identified. Long-term survival follow-up indicates that the toripalimab treatment group has a 5-year survival rate of 52%.-Fineline Info & Tech
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