Pembrolizumab as first-line therapy for patients with PD-L1-positive advanced non-small cell lung cancer: A phase 1 trial

Annals of Oncology

Volumn 28, Issue 4, 2017, Pages 874-881

  Hui, R ^a   Garon, E B ^b   Goldman, J W ^b   Leighl, N B ^c   Hellmann, M D ^d   Patnaik, A ^e   Gandhi, L ^f   Eder, J P ^g   Ahn, M J ^h   Horn, L ⁱ   Felip, E ^j   Carcereny, E ^k   Rangwala, R ^l   Lubiniecki, G M ^l   Zhang, J ^l   Emancipator, K ^l   Roach, C ^m   Rizvi, N A ⁿ  

^a UNIVERSITY OF SYDNEY   (Australia)

^b UNIVERSITY OF CALIFORNIA   (United States)

^c PRINCESS MARGARET HOSPITAL   (Canada)

^d WEILL CORNELL MEDICAL COLLEGE   (United States)

^e South Texas Accelerated Research Therapeutics   (United States)

^f DANA FARBER CANCER INSTITUTE   (United States)

^g YALE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^h Sungkyunkwan University School of Medicine   (South Korea)

ⁱ VANDERBILT INGRAM CANCER CENTER   (United States)

^j VALL D HEBRON UNIVERSITY HOSPITAL   (Spain)

^k CATALAN INSTITUTE OF ONCOLOGY   (Spain)

^l MERCK RESEARCH LABORATORIES   (United States)

^m AGILENT TECHNOLOGIES   (United States)

ⁿ Columbia University ^*  (United States)

more..

Author keywords

Anti PD 1; Immunotherapy; Non small cell lung cancer; Pembrolizumab

Indexed keywords

ASPARTATE AMINOTRANSFERASE; CREATINE KINASE; PEMBROLIZUMAB; PROGRAMMED DEATH 1 LIGAND 1; STEROID; THYROTROPIN; ANTINEOPLASTIC AGENT; CD274 PROTEIN, HUMAN; MONOCLONAL ANTIBODY;

ADRENAL INSUFFICIENCY; ADULT; ADVANCED CANCER; ADVERSE DRUG REACTION; AGED; ARTHRALGIA; ARTICLE; ASTHENIA; BRONCHOSPASM; CANCER CELL; CANCER PATIENT; CANCER SURVIVAL; CANCER TISSUE; COLITIS; CONSTIPATION; CONTROLLED STUDY; CREATINE KINASE BLOOD LEVEL; DECREASED APPETITE; DEHYDRATION; DERMATITIS; DIARRHEA; DISEASE SEVERITY; DRUG EFFICACY; DRUG FATALITY; DRUG SAFETY; DRUG TOLERABILITY; DYSPNEA; FATIGUE; FEMALE; HUMAN; HUMAN CELL; HUMAN TISSUE; HYPERKERATOSIS; HYPERTENSION; HYPOPHOSPHATEMIA; HYPOPHYSITIS; HYPOTHYROIDISM; INTERSTITIAL LUNG DISEASE; KIDNEY FAILURE; LUNG EMBOLISM; MAJOR CLINICAL STUDY; MALE; MYALGIA; MYXEDEMA; NAUSEA; NEURALGIA; NEUROMUSCULAR JUNCTION DISORDER; NON SMALL CELL LUNG CANCER; OPEN STUDY; OVERALL SURVIVAL; PERICARDIAL EFFUSION; PHASE 1 CLINICAL TRIAL; PLEURA EFFUSION; PNEUMONIA; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; PROTEIN EXPRESSION; PRURITUS; RANDOMIZED CONTROLLED TRIAL; RASH; SCORING SYSTEM; SURVIVAL RATE; SURVIVAL TIME; THYROTROPIN BLOOD LEVEL; TREATMENT RESPONSE; VASCULITIS; WEIGHT REDUCTION; ANTAGONISTS AND INHIBITORS; CARCINOMA, NON-SMALL-CELL LUNG; CLINICAL TRIAL; DISEASE FREE SURVIVAL; DOSE RESPONSE; KAPLAN MEIER METHOD; LUNG NEOPLASMS; MIDDLE AGED; MORTALITY; TREATMENT OUTCOME; VERY ELDERLY;

ADULT; AGED; AGED, 80 AND OVER; ANTIBODIES, MONOCLONAL, HUMANIZED; ANTIGENS, CD274; ANTINEOPLASTIC AGENTS; CARCINOMA, NON-SMALL-CELL LUNG; DISEASE-FREE SURVIVAL; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; HUMANS; KAPLAN-MEIER ESTIMATE; LUNG NEOPLASMS; MALE; MIDDLE AGED; TREATMENT OUTCOME;

EID: 85019062002     PISSN: 09237534     EISSN: 15698041     Source Type: Journal    
DOI: 10.1093/annonc/mdx008     Document Type: Article

References (24)

1. NCCN Clinical Practice Guidelines in Oncology: Non-small cell lung cancer-v4.2016; http://www.nccn.org/professionals/physician_gls/f_guidelines.asp (7 October 2016, date last accessed).
2. Schiller JH, Harrington D, Belani CP, et al. Comparison of four chemotherapy regimens for advanced non-small-cell lung cancer. N Engl J Med 2002; 346: 92-98.
3. Blank C, Mackensen A. Contribution of the PD-L1/PD-1 pathway to Tcell exhaustion: an update on implications for chronic infections and tumor evasion. Cancer Immunol Immunother 2007; 56: 739-745.
4. Khoja L, Butler MO, Kang SP, et al. Pembrolizumab. J Immunother Cancer 2015; 3: 36.
5. Garon EB, Rizvi NA, Hui R, et al. Pembrolizumab for the treatment of non-small-cell lung cancer. N Engl J Med 2015; 372: 2018-2028.
6. Dolled-Filhart M, Locke D, Murphy T, et al. Development of a prototype immunohistochemistry assay to measure programmed death ligand-1 expression in tumor tissue. Arch Pathol Lab Med 2016; 140: 1259-1266.
7. Dolled-Filhart M, Roach C, Toland G, et al. Development of a companion diagnostic for pembrolizumab in non-small cell lung cancer using immunohistochemistry for programmed death ligand-1. Arch Pathol Lab Med 2016; 140: 1243-1249.
8. Borghaei H, Paz-Ares L, Horn L, et al. Nivolumab versus docetaxel in advanced nonsquamous non-small-cell lung cancer. N Engl J Med 2015; 373: 1627-1639.
9. Barlesi F, Von Pawel J, Kowalski D, et al. Primary analysis from OAK, a randomized phase III study comparing atezolizumab with docetaxel in 2L/3L NSCLC. Presented at European Society for Medical Oncology (ESMO) 2016 Congress; October 7-11, 2016; Copenhagen, Denmark. Abstract LBA44_PR.
10. Fehrenbacher L, Spira A, Ballinger M, et al. Atezolizumab versus docetaxel for patients with previously treated non-small-cell lung cancer (POPLAR): a multicentre, open-label, phase 2 randomised controlled trial. Lancet 2016; 387: 1837-1846.
11. Rizvi NA, Hellmann MD, Brahmer JR, et al. Nivolumab in combination with platinum-based doublet chemotherapy for first-line treatment of advanced non-small-cell lung cancer. J Clin Oncol 2016; 34: 2969-2979.
12. Reck M, Rodriguez-Abreu D, Robinson AG, et al. Pembrolizumab versus chemotherapy for PD-L1-positive non-small-cell lung cancer. N Engl J Med 2016; 375: 1823-1833.
13. Socinski M, Horn L, Steins M, et al. CheckMate 026: a phase 3 trial of nivolumab vs investigator's choice (IC) of platinum-based doublet chemotherapy (PT-DC) as first-line therapy for stage IV/recurrent programmed death ligand 1 (PD-L1)-positive NSCLC. Presented at European Society for Medical Oncology (ESMO) 2016 Congress; October 7-11, 2016; Copenhagen, Denmark. Abstract LBA7_PR.
14. Gettinger S, Rizvi NA, Chow LQ, et al. Nivolumab monotherapy for firstline treatment of advanced non-small-cell lung cancer. J Clin Oncol 2016; 34: 2980-2987.
15. Besse B, Johnson ML, Janne PA, et al. Phase II single arm trial (BIRCH) of atezolizumab as first line or subsequent therapy for locally advanced or metastatic PD-L1 selected NSCLC. Presented at European Cancer Congress 2015; September 25-29, 2015, Vienna, Austria. Abstract 16LBA.
16. Hirsch FR, Averbuch S, Emami T, et al. The Blueprint Project: harmonizing companion diagnostics across a class of targeted therapies. Presented at: American Association for Cancer Research Annual Meeting 2016; April 16-20, 2016, New Orleans, LA.
17. Chatterjee M, Turner DC, Felip E, et al. Systematic evaluation of pembrolizumab dosing in patients with advanced non-small-cell lung cancer. Ann Oncol 2016; 27: 1291-1298.
18. Herbst RS, Baas P, Kim DW, et al. Pembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced non-small-cell lung cancer (KEYNOTE-010): a randomised controlled trial. Lancet 2016; 387: 1540-1550.
19. Langer CL, Gadgeel SM, Borghaei H, et al. Carboplatin and pemetrexed with or without pembrolizumab for advanced, non-squamous nonsmall- cell lung cancer: a randomised, phase 2 cohort of the open-label KEYNOTE-021 study. Lancet Oncol 2016; 17: 1497-1508.
20. Rizvi NA, Hellmann MD, Snyder A, et al. Mutational landscape determines sensitivity to PD-1 blockade in non-small cell lung cancer. Science 2015; 348: 124-128.
21. Chen PL, Roh W, Reuben A, et al. Analysis of immune signatures in longitudinal tumor samples yields insight into biomarkers of response and mechanisms of resistance to immune checkpoint blockade. Cancer Discov 2016; 6: 827-837.
22. Le DT, Uram JN, Wang H, et al. PD-1 blockade in tumors with mismatch-repair deficiency. N Engl J Med 2015; 372: 2509-2520.
23. Herbst RS, Soria JC, Kowanetz M, et al. Predictive correlates of response to the anti-PD-L1 antibody MPDL3280A in cancer patients. Nature 2014; 515: 563-567.
24. Tumeh PC, Harview CL, Yearly JH, et al. PD-1 blockade induces responses by inhibiting adaptive immune resistance. Nature 2014; 515: 568-571.