China-based Juncell Therapeutics reported that nolgileucel (GC101), its autologous tumor-infiltrating lymphocyte therapy, met the primary endpoint in a pivotal Phase II trial for patients with advanced melanoma who had progressed on prior PD-1 antibody therapy. The target population is characterized as having limited treatment options and historically poor outcomes, particularly in East Asia where acral and mucosal subtypes dominate.
MIZAR-003 is an open-label, randomized, active-controlled, multicenter Phase II trial initiated in December 2024 across 25 cancer centers in China. The study enrolled patients with advanced melanoma who had failed prior PD-1 antibody therapy; acral and mucosal subtypes accounted for 81.8% of participants, 89.9% had distant metastasis, and 66.7% had involvement of vital organs including liver, lungs, and bones — a heavily pretreated, high-burden population. The primary endpoint was progression-free survival (PFS). Nolgileucel demonstrated a median PFS of 4.3 months versus 1.6 months with chemotherapy (HR 0.43, 95% CI 0.26–0.68; P=0.0002), representing a 57% reduction in the risk of progression or death. The objective response rate (ORR) was 42.0% in the nolgileucel arm compared with 6.1% in the chemotherapy control, and some patients converted from partial response to complete response over time. Overall survival data remain immature but showed a directional benefit.
Unlike conventional TIL therapies that require high-dose interleukin-2 and high-intensity lymphodepletion, GC101 uses a low-intensity preconditioning regimen without IL-2, which the company reported translated into adverse events that were lower in both incidence and severity grade, with a median duration of eight days. The data were presented as a late-breaking abstract (LBA 9509) at the 2026 ASCO Annual Meeting.