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Table 1 Response rates and median overall survival with FDA approved anti-PD-1/PD-L1 blockade in metastatic urothelial carcinoma

From: Biomarkers for immunotherapy in bladder cancer: a moving target

  Medication Phase # Patients ORR (%) PFS (m.) OS (m.) PD-L1 Response Reference
Metastatic 2nd Line Therapy Atezolizumab I 100 21.0 8 Powles et al. [7]
II 310 15.0 2.1 7.9 PD-L1 on IC > 5% associated with ORR, testing not required for treatment Rosenberg et al. [8]
Pembrolizumab III P 270 21.6 2.1 10.3 PD-L1 TC and IC composite score > 10%, no difference in ORR or mOS Bellmunt et al. [13]
C 272 6.7 3.3 7.4
Nivolumab II 270 19.6 2.0 8.74 PD-L1 on TC > 1% not associated with ORR but associated with OS Sharma et al. [11]
Avelumab Ib/II 241 17.6 1.6 7.0 PD-L1 on TC > 5% associated with improved ORR, no OS data as of yet Apolo et al. [22]
Patel et al. [23]
Durvalumab Ib 191 17.8 Composite biomarker of PD-L1 > 25% on TC or IC predicts response rates, approved companion diagnostic Massard et al. [19, 21]
Metastatic 1st Line* Atezolizumab II 100 23.0 2.7 15.9 PD-L1 on IC not associated with improved ORR or mOS Balar et al. [10]
Pembrolizumab II 370 29.0 PD-L1 TC and IC composite score with cutoff of 10%, no difference noted in ORR Balar et al. [16]
  1. *Cisplatin Ineligible Patients