Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180), a leading biopharmaceutical company based in China, has announced that it has received marketing approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for its PD-1 inhibitor, toripalimab, marketed as Loqtorzi. This approval allows the use of toripalimab in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with recurrent, inoperable, or metastatic nasopharyngeal carcinoma (NPC), and in combination with cisplatin and paclitaxel for the first-line treatment of adult patients with unresectable advanced, recurrent, or metastatic oesophageal squamous cell carcinoma (ESCC).
Toripalimab’s Clinical Impact and Approvals
Toripalimab, China’s first domestically approved PD-1 inhibitor for second-line treatment of melanoma in December 2018, has garnered more than ten indication approvals in China to date. With over 40 clinical trials initiated covering over 15 indications, the drug’s global reach is expanding. The NPC indication approval is primarily supported by the global, multi-center Phase III JUPITER-02 study, which demonstrated a 48% reduction in the risk of disease progression and a 37% reduction in the risk of death when compared to chemotherapy alone. The median progression-free survival (PFS) was significantly prolonged from 8.2 months to 21.4 months in the toripalimab plus chemotherapy group, and the 5-year survival rate reached 52.0%.
ESCC Indication and Survival Benefits
The approval for the ESCC indication is backed by the Phase III JUPITER-06 study, which showed superior PFS and overall survival (OS) in patients with advanced or metastatic ESCC. The median OS was extended by 6 months to 17 months, and the risk of disease progression or death was significantly reduced by 42%. Notably, the survival benefits were observed regardless of PD-L1 status, indicating the broad potential of toripalimab in treating these cancers.-Fineline Info & Tech
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