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A Phase III, Randomized, Placebo Controlled, Multicenter, Double-Blind Study Comparing Toripalimab Injection (JS001) Combined With Chemotherapy Versus Placebo Combined With Chemotherapy for Recurrent or Metastatic Nasopharyngeal Cancer

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Trial Profile

A Phase III, Randomized, Placebo Controlled, Multicenter, Double-Blind Study Comparing Toripalimab Injection (JS001) Combined With Chemotherapy Versus Placebo Combined With Chemotherapy for Recurrent or Metastatic Nasopharyngeal Cancer

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 31 Mar 2025

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At a glance

  • Drugs Toripalimab (Primary) ; Cisplatin; Gemcitabine
  • Indications Nasopharyngeal cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms JUPITER-02
  • Sponsors Shanghai Junshi Biosciences

Most Recent Events

  • 26 Mar 2025 According to a Junshi Biosciences Media Release, company announced that the New Drug Application for toripalimab in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with recurrent, not amenable to surgery or radiotherapy, or metastatic nasopharyngeal carcinoma has been approved by the Singapore Health Sciences Authority. The approval is primarily based on the results from JUPITER-02 trial.
  • 17 Jan 2025 According to a Junshi Biosciences Media Release, company announced that the marketing authorization application for the toripalimab was recently approved by the Australian Therapeutic Goods Administration (TGA) for the treatment of two nasopharyngeal carcinoma (NPC) indications, based on the research results of JUPITER-02 and POLARIS-02 study.
  • 16 Nov 2024 According to a Junshi Biosciences Media Release, company announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved toripalimab (UK trade name: LOQTORZI) for NPC indication.

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