China-based Junshi Biosciences (HKG: 1877, SHA: 688180) has announced that it has filed for market approval with the Medicines and Healthcare products Regulatory Agency (MHRA) of the UK for its programmed death-1 (PD-1) inhibitor Tuoyi (toripalimab). The filing seeks approval for the checkpoint inhibitor in combination with chemotherapy as a first-line treatment for locally recurrent or metastatic nasopharyngeal carcinoma (NPC) and unresectable locally advanced/recurrent or metastatic esophageal squamous cell carcinoma (ESCC). The same indications were previously filed with the European Medicine Agency (EMA).
Clinical Trial Results
The filings are based on the results of the JUPITER-02 study (NCT03581786) for NPC and the JUPITER-06 study (NCT03829969) for ESCC. The JUPITER-02 study results, published in Nature Medicine (IF=87.241) in September 2021, showed that for patients with recurrent or metastatic NPC who had not received systematic treatment, the median progression-free survival (PFS) in the toripalimab combined chemotherapy group was significantly longer than that in the placebo combined chemotherapy group (21.4 vs. 8.2 months), reducing the risk of disease progression or death by 48% (HR=0.52, 95% CI: 0.37-0.73, bilateral P<0.0001).
The JUPITER-06 study results, published in Cancer Cell (IF=38.585), showed that for patients with advanced or metastatic ESCC without systematic chemotherapy, the median overall survival (OS) was significantly extended to 17 months, reducing the risk of disease progression or death by 42% (HR=0.58, P<0.0001). Patients enjoyed clinical benefits regardless of PD-L1 expression status.
Regulatory and Market History
Toripalimab was China’s first domestic PD-1 inhibitor to be approved in December 2018 as a second-line treatment for melanoma. Subsequent approvals were granted in February 2021 for NPC, in April 2021 for locally advanced or metastatic urothelial cancer (UC), in November 2021 for first-line NPC, and in May 2022 for first-line ESCC. The molecule was included on the National Reimbursement Drug List (NRDL) for NPC and UC indications last year.-Fineline Info & Tech
