China-based Junshi Biosciences (HKG: 1877, SHA: 688180) announced that a market approval filing has been made for its programmed death-1 (PD-1) inhibitor Tuoyi (toripalimab) with the European Medicines Agency (EMA). The biotech is seeking approval for the checkpoint inhibitor in combination with chemotherapy as a first-line treatment for locally recurrent or metastatic nasopharyngeal carcinoma (NPC), and with chemotherapy as a first-line treatment for unresectable locally advanced/recurrent or metastatic esophageal squamous cell carcinoma (ESCC).
Clinical Trial Results
The filing for NPC is based on the results of the JUPITER-02 study (NCT03581786) and the POLARIS-02 study (NCT02915432), while the ESCC indication is backed by the JUPITER-06 study (NCT03829969).
Regulatory Milestones and Approvals
Toripalimab was China’s first domestic PD-1 inhibitor to be approved (in December 2018) as a second-line treatment for melanoma. Further indication nods were granted in February 2021 as a second-line treatment of NPC, in April 2021 for locally advanced or metastatic urothelial cancer (UC) in previously treated patients, in November 2021 as a first-line treatment for NPC, and in May 2022 as a first-line treatment of ESCC. The molecule was included on the National Reimbursement Drug List (NRDL) for three indications last year, the only PD-1 inhibitor to treat melanoma and NPC on the list.
US Regulatory Status
Meanwhile, in the US, Junshi has obtained two breakthrough therapy designations (BTDs), one fast-track status, and one priority review status, along with five orphan drug designations (ODDs) for toripalimab’s use in mucosal melanoma, nasopharyngeal carcinoma, soft tissue sarcoma, esophageal cancer, and small-cell lung cancer. A Biologic License Application (BLA) for the drug as a treatment for second-line NPC and with chemo for first-line NPC was accepted for review by the US FDA in July of this year, with a PDUFA date set as December 23, 2022.-Fineline Info & Tech
