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Background

mUM is a historically treatment-refractory tumor with high expression of gp100 and 12 month (mo) OS rate of 43%(Khoja L, et al. Ann Oncol. 2019; 30 (8): 1370-1380). Tebe is a bispecific consisting of an affinity-enhanced T-cell receptor fused to an anti-CD3 effector that can redirect T cells to target gp100+ cells (melanocytes and melanoma). An intra-patient escalation regimen evaluated in Ph1 of the current study identified 68 μg as the phase 2 dose (Sato T et al. J. Clin. Oncol. 2018; 36 (15_suppl): 9521).

Methods

We conducted a Ph2 study of tebe in mUM pts. HLA-A* 0201+ pts were treated at 24 centers with a regimen of QW iv dosing (20μg C1D1; 30μg C1D8; 68μg C1D15). 1 objective was ORR by RECIST 1.1 using independent central review (ICR). 2 objectives included safety, OS and PFS.

Results

127 pts were treated (50% male; 70% ECOG 0, 58% LDH> ULN). All pts received≥ 1 prior therapy in …