UK MHRA Approves Junshi Biosciences' Toripalimab for Nasopharyngeal and Esophageal Cancers
核心洞察
The UK MHRA has approved toripalimab for recurrent or metastatic nasopharyngeal carcinoma (搜索) (NPC) in combination with cisplatin and gemcitabine.
Toripalimab is also approved in combination with cisplatin and paclitaxel for unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma (搜索) (ESCC).
Toripalimab is the first and only drug approved in the UK for NPC treatment and the only first-line treatment for advanced or metastatic ESCC, regardless of PD-L1 (搜索) status.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization to toripalimab (LOQTORZI®), an anti-PD-1 (搜索) monoclonal antibody developed by Junshi Biosciences, for two distinct indications in the treatment of nasopharyngeal carcinoma (搜索) (NPC) and esophageal squamous cell carcinoma (搜索) (ESCC). This approval marks a significant advancement in cancer therapy, providing new hope for patients with these challenging malignancies.
Toripalimab Approved for NPC
Toripalimab, in combination with cisplatin and gemcitabine, is now approved for the first-line treatment of adult patients with recurrent, non-amenable to surgery or radiotherapy, or metastatic NPC. NPC is a malignant tumor of the nasopharyngeal mucosal epithelium, with over 120,000 new cases diagnosed worldwide in 2022, according to GLOBOCAN statistics. Surgery is often not an option due to the tumor's location, making systemic therapies crucial.
The approval is primarily based on the JUPITER-02 study (NCT03581786), a Phase 3, randomized, double-blind, placebo-controlled, multinational, multi-center clinical trial. The study demonstrated that toripalimab combined with chemotherapy significantly reduced the risk of disease progression by 48% and the risk of death by 37% compared to chemotherapy alone. The median progression-free survival (PFS) in the toripalimab plus chemotherapy group was 21.4 months, compared to 8.2 months in the chemotherapy-alone group. Furthermore, the 5-year survival rate was 52.0% with the combined therapy, as presented at ASCO 2024.
Toripalimab Approved for ESCC
In addition to NPC, toripalimab, in combination with cisplatin and paclitaxel, has been approved for the first-line treatment of adult patients with unresectable advanced, recurrent, or metastatic ESCC. Esophageal cancer, the 11th most commonly diagnosed cancer globally, includes ESCC as one of its primary histological subtypes.
The approval for ESCC is supported by the JUPITER-06 study (NCT03829969), a Phase 3, randomized, double-blind, placebo-controlled, multi-center clinical trial. Results from this study showed that toripalimab in combination with chemotherapy led to superior PFS and OS in patients with advanced or metastatic ESCC. The median OS was prolonged by 6 months to 17 months, and the risk of disease progression or death was significantly reduced by 42%. The survival benefits were observed regardless of PD-L1 (搜索) status.
Significance of the Approval
Dr. Jianjun ZOU, General Manager and CEO of Junshi Biosciences, emphasized the importance of this regulatory milestone, stating that toripalimab is now the first and only drug in the UK for the treatment of NPC and the only first-line treatment for ESCC, irrespective of PD-L1 (搜索) status. This approval addresses significant unmet medical needs for patients in the UK.
About Toripalimab
Toripalimab is an anti-PD-1 (搜索) monoclonal antibody designed to block PD-1 interactions with its ligands, PD-L1 (搜索) and PD-L2 (搜索), enhancing the immune system's ability to target and eliminate tumor cells. Junshi Biosciences has conducted over forty company-sponsored clinical studies globally, covering more than fifteen indications. In mainland China, toripalimab is marketed as TUOYI® and has received approval for ten indications.