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Table 1 Characteristics of immune-checkpoint inhibitors approved by US FDA

From: Clinical benefit of immune checkpoint inhibitors approved by US Food and Drug Administration

Approved drug

Indications

Pivotal Trial

Primary endpoint

Sample size

Year of approval

Pembrolizumab plus chemotherapy

First-line therapy of metastatic non-squamous NSCLC

KEYNOTE-189

OS and PFS

616

2018

Nivolumab plus ipilimumab

First-line therapy of intermediate or poor risk advanced renal cell carcinoma

CHECKMATE-214

OS, ORR and PFS

847

2018

Durvalumab

Consolidation therapy for stage III NSCLC who did not have disease progression after two or more cycles of platinum-based chemoradiotherapy

PACIFIC

PFS and OS

713

2018

Atezolizumab

Second line therapy of NSCLC

OAK

OS

850

2016

Pembrolizumab

Second line therapy foradvanced urothelial carcinoma

KEYNOTE-45

PFS and OS

542

2017

Pembrolizumab

First-line NSCLC with tumors express PD-L1 > 50% as determined by an FDA-approved test

KEYNOTE-24

PFS

305

2017

Pembrolizumab

Second line therapy of metastatic NSCLC whose tumors express PD-L1

KEYNOTE-010

PFS and OS

1034

2016

Pembrolizumab

First-line therapy of melanoma

KEYNOTE-006

PFS and OS

834

2015

Nivolumab

Adjuvant therapy of melanoma

CHECKMATE-238

RFS

906

2017

Nivolumab

Second line therapy of squamous-cell carcinoma of the head and neck

CHECKMATE-141

OS

361

2016

Nivolumab

Second line therapy of renal cell carcinoma

CHECKMATE-025

OS

821

2015

Nivolumab

Second line therapy of advanced squamous-cell NSCLC

CHECKMATE-017

OS

272

2015

Nivolumab

Second line therapy of advanced nonsquamous NSCLC

CHECKMATE-057

OS

582

2015

Nivolumab

First line therapy of BRAF wild-type unresectable or metastatic melanoma

CHECKMATE-066

OS

418

2015

Nivolumab with or without ipilimumab

First line therapy of unresectable or metastatic melanoma

CHECKMATE-067

PFS and OS

945

2015

Pembrolizumab

Second line therapy of unresectable or metastatic melanoma

KEYNOTE-002

PFS

540

2015

Ipilimumab

Adjuvant therapy of melanoma

EORTC-18071

RFS

951

2015

Ipilimumab

Second line therapy of unresectable or metastatic melanoma

MDX010–20

OS

676

2011

  1. FDA Food and Drug Administration, NSCLC Non–small cell lung cancer, PD-L1 Programmed death-ligand 1, OS Overall survival, PFS Progression-free survival, RFS Recurrence-free survival