Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has announced that the Hong Kong Drug Office (DO) has accepted two indication approval filings for its programmed death-1 (PD-1) inhibitor, Loqtorzi (toripalimab). The filings seek approval for the drug in combination with chemotherapy as a first-line treatment for metastatic or recurrent locally advanced nasopharyngeal carcinoma (NPC), and as a monotherapy for recurrent, unresectable, or metastatic NPC that has progressed during or after previous platinum-containing treatment.
The applications are supported by the results of the JUPITER-02 and POLARIS-02 studies. JUPITER-02 demonstrated that the combination of toripalimab and chemotherapy significantly improved progression-free survival (PFS) and overall survival (OS) in patients with recurrent/metastatic NPC compared to chemotherapy alone. The median PFS was 21.4 months, and the 3-year OS rate was 64.5%. The combination therapy reduced the risk of disease progression or death by 48% and mortality by 37%, with a manageable safety profile.
The POLARIS-02 study showed that toripalimab maintained anti-tumor activity and safety in patients with recurrent/metastatic NPC who had failed prior chemotherapy. The objective response rate (ORR) was 20.5%, the median duration of response (DoR) was 12.8 months, and the median OS was 17.4 months.
Toripalimab, China’s first domestically approved PD-1 inhibitor, was initially approved in December 2018 for second-line treatment of melanoma. It has since received a total of eight indication approvals in China.-Fineline Info & Tech
