Abstract
TPS8069Background: Pembrolizumab is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, leading to antitumor immune response. In the phase 1 KEYNOTE-023 trial of pembrolizumab + lenalidomide and low-dose dexamethasone, the treatment combination had an acceptable safety profile and promising preliminary efficacy in patients with relapsed/refractory MM, supporting further evaluation of pembrolizumab for patients with MM. The randomized, open-label, multicenter, phase 3 KEYNOTE-185 study (NCT02579863) was designed to compare the efficacy and safety of lenalidomide and low-dose dexamethasone (standard of care) with or without pembrolizumab in patients with newly diagnosed and treatment-naive MM. Methods: Eligible patients must be aged ≥ 18 years, have newly diagnosed, treatment-naive active MM with measurable disease and be ineligible for autologous stem cell transplant. Patients are to be randomized 1:1 to receive lenalidomide 25 mg daily on days 1-21 an...
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