1590TiPSafety, tolerability and activity of autologous T-cells with enhanced T-cell receptors specific to NY ESO 1/LAGE 1a (GSK3377794) alone, or in combination with pembrolizumab, in advanced non-small cell lung cancer: A phase Ib/IIa randomised pilot study

AbstractBackgroundNY-ESO-1 and LAGE-1a are antigens expressed in several tumours, including non-small cell lung cancer (NSCLC). Previous clinical trials using autologous T cells directed against NY-ESO-1/LAGE-1a have shown objective responses between 40% and 60% in synovial sarcoma, metastatic melanoma and multiple myeloma. Pembrolizumab (PEM) is a monoclonal antibody that blocks PD-1/PD-L1 interaction and increases anti-tumour activity in anti-tumour T cells. Here, PEM will be used in combination with NY-ESO-1/LAGE-1a T-cell receptor engineered patient T cells (GSK3377794) to potentially improve clinical benefit in this patient population.Trial designThis is a phase Ib/IIa, randomised, multi-arm, open-label study (NCT03709706) of GSK3377794 in HLA-A*02:01, HLA-A*02:05 and/or HLA-A*02:06 positive adults with NY-ESO-1 and/or LAGE-1a-expressing tumours. Eligible patients with unresectable Stage IIIb/IV NSCLC are either ineligible for standard-of-care chemoradiotherapy, have received PD-1 therapy or appropriate targeted therapy, have terminated prior treatment due to intolerable side effects, or have refused standard approved treatment. At least 30 patients with NSCLC without EGFR or ALK/ROS1 aberrations will be randomised (1:1) to Arm A or B; at least 15 patients with EGFR or ALK/ROS1 aberration will be assigned to Arm C. Patients in Arm A will receive a single IV infusion of GSK3377794; those in Arms B and C will receive GSK3377794 IV on Day 1, then PEM 200  mg starting on D...
Source: Annals of Oncology - Category: Cancer & Oncology Source Type: research