Suthee Rapisuwon, MD, discusses the potential utility of toripalimab in melanoma subtypes.
Suthee Rapisuwon, MD, medical oncologist, MedStar Health, discusses the potential utility of toripalimab in melanoma subtypes.
Toripalimab, a PD-1 inhibitor, was developed in China, where it is currently approved for marketing, says Rapisuwon. As monotherapy, toripalimab demonstrated similar activity compared with other checkpoint inhibitors, such as pembrolizumab (Keytruda) and nivolumab (Opdivo), in patients with cutaneous melanoma. Response rates with single-agent toripalimab appear to be more modest in acral and mucosal melanoma subtypes, Rapisuwon explains.
However, on January 25, 2021, the FDA granted toripalimab a fast track designation for use in the frontline treatment of patients with mucosal melanoma.
Moreover, the regulatory designation gave the green light to an investigational new drug application for a phase 3 trial that will randomize patients with unresectable, locally advanced or metastatic mucosal melanoma to frontline toripalimab plus axitinib (Inlyta) or pembrolizumab. Previous data from a phase 1b trial (NCT03086174) demonstrated a 48.5% overall response rate with toripalimab plus axitinib in this patient population, concludes Rapisuwon.