Companion PD-L1 Assays in Development for PD-1/PD-L1 Inhibitors

DrugDrug targetCompanion antibody cloneDeveloperDefinition of positive test
NivolumabPD-128-8Dako≥5 % membranous staining of tumor cells (minimum 100 cells evaluated)
Bristol-Meyers Squibb
PembrolizumabPD-122C3Dako≥1%a membranous staining of tumor cells or immune cells that are intercalating or at the tumor interface
Merck
Atezolizumab (MPDL3280A)PD-L1SP142VentanaEach specimen assigned a score based on both tumor and immune cell PD-L1:
Genentech/Roche
TC3/IC3 PD-L1 ≥ 50 %
TC2/IC2 PD-L1 5-49 %
TC1/IC1 PD-L1 1-4 %
TC0/IC0 PD-L1 < 1 %
Durvalumab (MEDI4736)PD-L1SP263Ventana≥25 % membranous staining of tumor cells
MedImmune/AstraZeneca

aThe FDA indication in NSCLC for pembrolizumab requires PS ≥50 %