Junshi Biosciences plans to seek Chinese approval of toripalimab as a first-line treatment for patients with recurrent or metastatic nasopharyngeal carcinoma after the company announced that a Phase III study of the PD-1 monoclonal antibody met its pre-specified primary endpoint. Along with a filing to China's National Medical Products Administration (NMPA), Junshi said it will submit marketing applications to other regulatory authorities in the near future.
The JUPITER-02 study randomised 289 patients with recurrent or metastatic nasopharyngeal carcinoma to receive toripalimab or placebo, both in combination with gemcitabine and cisplatin, as a first-line treatment. The trial's main goal is progression-free survival (PFS), while secondary endpoints include overall survival, objective response rate, duration of response and disease control rate.
Junshi noted that at the interim analysis, the independent data monitoring committee determined that the study met its primary endpoint, with toripalimab significantly prolonging PFS versus placebo. Earlier this month, the FDA granted a breakthrough therapy designation to toripalimab for the treatment of nasopharyngeal carcinoma.
Toripalimab was first approved in China in 2018 for second-line metastatic melanoma, while in April this year, the NMPA accepted an application seeking clearance for the drug in recurrent or metastatic nasopharyngeal carcinoma after failure of at least two prior systemic treatments. Meanwhile, a filing for toripalimab to treat locally advanced or metastatic urothelial carcinoma after systemic treatment has also been accepted by the Chinese regulator.
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