FDA Grants Fast Track Designation to Toripalimab for Mucosal Melanoma

The FDA has granted toripalimab a fast track designation for use in the frontline treatment of patients with mucosal melanoma.

The FDA has granted toripalimab a fast track designation for use in the frontline treatment of patients with mucosal melanoma, according to an announcement from Junshi Biosciences, the drug developer.1 Toripalimab has been approved for marketing in China and over 30 trials have investigated its use spanning 15 indications on a global scale.

The regulatory agency also gave the green light to an investigational new drug application for a phase 3 trial that will examine the PD-1 monoclonal antibody in combination with axitinib (Inlyta) compared with pembrolizumab (Keytruda) in the first-line treatment of 220 patients with unresectable, locally advanced or metastatic mucosal melanoma. In the trial, participants will be randomized 1:1 to either toripalimab plus axitinib or pembrolizumab. The primary end point of the trial is progression-free survival (PFS), with key secondary end points comprised of objective response rate (ORR), duration of response (DOR), overall survival (OS), and safety.

Previously, data from a single-arm, open-label phase 1b trial (NCT03086174) showed that the toripalimab/axitinib combination demonstrated promising activity in patients with advanced mucosal melanoma.2 Specifically, the combination elicited an ORR of 48.5%, which included 1 complete response and 15 partial responses. The median DOR was 13.7 months with the doublet.

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