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 |