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Table 1 Summary of clinical indication and ongoing evaluation of immune checkpoint inhibitors in major cancer types

From: Current status and perspectives in translational biomarker research for PD-1/PD-L1 immune checkpoint blockade therapy

Target Drug Class Company Clinical indication and ongoing evaluation (status; approval date; trial identifier; country)
CTLA-4 Ipilimumab (Yervoy®, MDX-010, MDX-101) Human IgG1/kappa Bristol-Myers Squibb Metastatic melanoma (US FDA approved on March 25, 2011); metastatic NSCLC (phase I has been completed; NCT01165216; Japan; phase II reported, NCT00527735, USA; phase III ongoing, NCT01285609; USA; phase III ongoing NCT02279732; China)
Tremelimumab (ticilimumab, CP-675206) Human anti-CTLA-4 IgG2 mab MedImmune/AstraZeneca Metastatic melanoma (phase I has been completed; NCT01103635; USA; phase II has been completed, NCT00471887, USA); advanced hepatocellular carcinoma (phase II has been completed; NCT01008358; Spain); Metastatic NSCLC (phase Ib has been reported, NCT02000947, USA; phase II has been reported, NCT02179671, USA; first line, phase III MYSTIC ongoing; NCT02453282; USA)
PD-1 Nivolumab (Opdivo®, ONO-4538, MDX-1106, BMS-936558) Human IgG4/kappa Bristol-Myers Squibb; Ono Pharmaceuticals Metastatic melanoma (Japan approval on July 4, 2014; US FDA accelerated approval on December 22, 2014; US FDA approval of nivolumab in combination with ipilimumab for BRAF V600 wild-type tumor on September 30, 2015); Squamous NSCLC (US FDA approval on March 4, 2015; European Commission on July 20, 2015); expands to non-squamous NSCLC (US FDA approval on October 9, 2015); advanced (metastatic) renal cell carcinoma (US FDA approval on November 23, 2015); classical Hodgkin lymphoma that has relapsed or progressed after autologous hematopoietic stem cell transplantation and post-transplantation brentuximab vedotin (US FDA approval on May 17, 2016)
Pembrolizumab (Keytruda®, lambrolizumab, MK-3475) Humanized IgG4 Merck & Co. Metastatic melanoma (USA accelerated approval on September 4, 2014 for patients with disease progression after ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor; US FDA expanded to initial treatment on December 18, 2015); metastatic NSCLC whose tumors express PD-L1 as determined by an FDA-approved test and who have disease progression on or after platinum-containing chemotherapy (US FDA approval on October 2, 2015)
Pidilizumab (CT-011) Humanized IgG1 CureTech Ltd Diffuse large-B cell lymphoma (phase II has been completed; NCT00532259; USA); metastatic melanoma (phase II has been completed; NCT01435369; USA)
AMP-514 (MEDI0680) Humanized IgG4 MedImmune Advanced malignancies (phase II is currently recruiting participants; NCT02013804; USA)
AUNP-12 Peptide antagonist Aurigene, Pierre Fabre Cancer (preclinical phase, Aurigene granted Pierre Fabre worldwide rights to develop AUNP12 for cancer indications; announced on February 11, 2014; India)
PD-L1 BMS936559 (MDX-1105) Human IgG4 Bristol-Myers Squibb Advanced or recurrent solid tumors (phase II has been completed; NCT00729664; USA)
Atezolizumab (Tecentriq™, MPDL3280A, RG7446) Human IgG1 Roche & Genentech Metastatic bladder cancer (phase III, US FDA granted breakthrough therapy designation on May 31, 2014; priority review on March 14, 2016; accelerated approval on May 18, 2016); metastatic NSCLC (phase III, US FDA grants breakthrough therapy designation on February 1, 2015)
Durvalumab (MEDI4736) Humanized IgG1 AstraZeneca Glioblastoma (phase II is currently recruiting participants; NCT02336165; USA); metastatic squamous cell carcinoma of the head and neck (phase II is currently recruiting participants; NCT02207530; USA); advanced or metastatic NSCLC (phase III is currently recruiting participants; NCT02352948; Global study); advanced colorectal cancer (phase II is currently recruiting participants; NCT02227667; USA); metastatic NSCLC (first line phase III MYSTIC is current recruiting participants; NCT02453282; USA; first line phase III ARCTIC is current recruiting participants; NCT02352948; Global); metastatic bladder cancer (US FDA granted breakthrough therapy designation for PD-L1-positive tumors in patients who progressed during or after one standard platinum-based regimen on February 17, 2016)
Avelumab (MSB0010718C) Fully humanized IgG1 Merck KGaA, EMD Serono, Pfizer Advanced solid tumors (phase I with consecutive parallel group expansion; currently recruiting participants in multiple tumor types and settings; NCT01772004; USA); metastatic NSCLC (phase III is currently recruiting participants after failure of a platinum-based doublet; NCT02395172; and first line versus platinum doublet; NCT02576574; USA)
PD-L2 AMP-224 PD-L2-IgG2a fusion protein Amplimmune Advanced cancer (phase II has been completed; NCT01352884; USA)
  1. Last assessed information at ClinicalTrial.gov on December 28, 2015; updated FDA approvals on May 18, 2016. Italicized data highlights major cancer types in clinical evaluation
  2. Abbreviations: CTLA-4 cytotoxic T-lymphocyte-associated protein 4, NSCLC non-small-cell lung cancer, PD1 programed cell-death protein 1, PDL1 programed cell-death ligand 1