Multicenter phase 3 trial of first-line toripalimab versus dacarbazine for advanced melanoma predominantly of acral subtype

The phase 3 MELATORCH randomized clinical trial, at 11 centers in China, compared toripalimab (PD-1 inhibitor) with dacarbazine as first-line therapy for advanced melanoma predominantly of acral subtype. Patients with no prior systemic therapy for stage III or IV melanoma were randomized 1:1 to receive toripalimab 240 mg every 2 weeks for up to 2 years (n=127), or dacarbazine 1000 mg/m² every three weeks (n=128) until disease progression or intolerable toxicity. Patients in the dacarbazine group were allowed to receive toripalimab after radiographic disease progression. Among 256 patients, 169 (62.7%) had acral melanoma. The median duration of follow-up was 11.8 months (range 0.1-62.5). Toripalimab significantly reduced the blinded independent central review-assessed risk of disease progression or death compared with dacarbazine (HR 0.71; p=0.02). Consistent PFS benefit was observed in most predefined subgroups, including patients with acral subtype. The safety profile of toripalimab was acceptable. The authors conclude that toripalimab could be used as a new first-line treatment option for advanced melanoma, particularly where acral cutaneous melanoma is the predominant subtype.