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Junshi Biosciences : FDA Grants Toripalimab Fast Track Designation For Mucosal Melanoma

Junshi Biosciences said that U.S. Food and Drug Administration has granted toripalimab Fast Track designation for the first-line treatment of mucosal melanoma.

Meanwhile, the FDA has also approved the Investigational New Drug (IND) application for a global Phase III trial of Toripalimab in combination with Axitinib versus Pembrolizumab for the first-line treatment of patients with advanced mucosal melanoma.

The trial plans to enroll 220 patients who will be randomized at 1:1 ratio into two study arms. The primary endpoint of the Combination Clinical Trial is progression-free survival (PFS). The secondary endpoints include objective response rate (ORR), duration of response (DOR), overall survival (OS), and safety.

Mucosal melanoma is a subtype of melanoma with mucosal origin. Compared with cutaneous melanoma, mucosal melanoma is less responsive to traditional chemotherapy and immunotherapy, and thus remains an unmet medical need.

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