Shanghai Junshi Biosciences (Junshi Biosciences) and its wholly owned subsidiary, TopAlliance Biosciences said that the European Commission (EC) has approved toripalimab for marketing in the European Union (EU), as Loqtorzi.
Toripalimab has been approved in combination with cisplatin and gemcitabine for the first-line treatment of adult patients having recurrent or metastatic nasopharyngeal carcinoma (NPC).
The second approval is for its combination with cisplatin and paclitaxel for the first-line treatment of adults with unresectable advanced or metastatic oesophageal squamous cell carcinoma (ESCC).
In July this year, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion for the marketing authorisation application (MAA) of toripalimab for the two indications.
The anti-PD-1 monoclonal antibody is now the first and only drug in Europe for treating NPC and the only first-line treatment for ESCC, irrespective of PD-L1 status.
The approval for the NPC indication is mainly based on the JUPITER-02 Phase 3 study.
Results showed that toripalimab combined with chemotherapy reduced disease progression risk by 48% and death risk by 37% compared to chemotherapy alone.
Median progression-free survival (PFS) increased from 8.2 months to 21.4 months.
Additionally, this combination therapy led to a higher objective response rate (ORR) and longer duration of response (DoR), with no new safety signals.
Long-term survival follow-up data reported a five-year survival rate of 52%.
The approval for the ESCC indication is based on the Phase 3 JUPITER-06 study. It evaluated the efficacy and safety of toripalimab with paclitaxel and cisplatin (TP) for treating advanced ESCC.
Results showed that this combination therapy significantly improved both PFS and overall survival (OS).
The median OS extended by six months to 17 months, and the risk of disease progression or death was reduced by 42%.
In addition, the study demonstrated an improvement in survival benefits regardless of PD-L1 status.
Junshi Biosciences general manager and CEO Jianjun ZOU said: “The approval of toripalimab by the EC signifies that, following our success in China and the US, our global commercial strategy has officially expanded into Europe.
“It also reflects the international recognition of our research and production quality for innovative drugs.”
Developed by Junshi Biosciences, toripalimab has undergone over 40 clinical studies across 15 indications globally.
In China, it is approved for 10 indications, including melanoma and NPC.
The US Food and Drug Administration (FDA) has also approved toripalimab for treating NPC.
