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, 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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