Table 1 Anti-PD-1 monotherapy approvals with PD-L1 companion diagnostic.

From: Is PD-L1 a consistent biomarker for anti-PD-1 therapy? The model of balstilimab in a virally-driven tumor

Clinical trials for which only PD-L1+ patients were treated

Keytruda in 1L NSCLC

KEYNOTE-024

Tecentriq in 1L NSCLC

IMpower110

Clinical trials for which relatively few PD-L1− patients were assessed

Keytruda in chemotherapy-resistant cervical cancer

 • 16% PD-L1- pts (N = 16)

KEYNOTE-158 (Cohort E)

Clinical trials demonstrating limited benefit in PD-L1− patients

Keytruda in 2L+ esophageal

 • 1° endpoint met only in PD-L1 selected pts

KEYNOTE-181

Keytruda in 1L SCCHN

 • No benefit vs cetuximab in PD-L1 unselected pts

KEYNOTE-048

Keytruda in 1L urothelial cancer

 • Less benefit vs platinum-based chemo in PD-L1- pts

KEYNOTE-052

KEYNOTE-361

Tecentriq in 1L urothelial cancer pts who are ineligible for platinum-based chemo

 • Less benefit vs platinum-based chemo in PD-L1- pts

IMvigor210

IMvigor130

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