Overall survival and long-term safety of nivolumab (anti-programmed death 1 antibody, BMS-936558, ONO-4538) in patients with previously treated advanced non-small-cell lung cancer

Journal of Clinical Oncology

Volumn 33, Issue 18, 2015, Pages 2004-2012

  Gettinger, Scott N ^a   Horn, Leora ^a   Gandhi, Leena ^a   Spigel, David R ^a   Antonia, Scott J ^a   Rizvi, Naiyer A ^a   Powderly, John D ^a   Heist, Rebecca S ^a   Carvajal, Richard D ^a   Jackman, David M ^a   Sequist, Lecia V ^a   Smith, David C ^a   Leming, Philip ^b   Carbone, David P ^a   Pinder Schenck, Mary C ^a   Topalian, Suzanne L ^a   Hodi, F Stephen ^a   Sosman, Jeffrey A ^a   Sznol, Mario ^a   McDermott, David F ^a   Pardoll, Drew M ^a   Sankar, Vindira ^a   Ahlers, Christoph M ^a   Salvati, Mark ^a   Wigginton, Jon M ^a   Hellmann, Matthew D ^a   Kollia, Georgia D ^a   Gupta, Ashok K ^a   Brahmer, Julie R ^a   more..

^a BRISTOL MYERS SQUIBB   (United States)

^b CHRIST HOSPITAL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

NIVOLUMAB; ANTINEOPLASTIC AGENT; MONOCLONAL ANTIBODY; PDCD1 PROTEIN, HUMAN; PROGRAMMED DEATH 1 RECEPTOR;

ADULT; ADVANCED CANCER; AGED; ARTICLE; CANCER CHEMOTHERAPY; CANCER SURVIVAL; CONTROLLED STUDY; DEATH; DECREASED APPETITE; DIARRHEA; DISEASE COURSE; DRUG DOSE ESCALATION; DRUG DOSE INCREASE; DRUG RESPONSE; DRUG SAFETY; DRUG WITHDRAWAL; ENDOCRINE DISEASE; FATIGUE; FEMALE; FOLLOW UP; GASTROINTESTINAL DISEASE; HUMAN; HUMAN TISSUE; IMMUNOHISTOCHEMISTRY; INFUSION RELATED REACTION; INTERSTITIAL LUNG DISEASE; KIDNEY DISEASE; LIVER DISEASE; LUNG DISEASE; MAJOR CLINICAL STUDY; MALE; MULTIPLE CYCLE TREATMENT; NON SMALL CELL LUNG CANCER; OVERALL SURVIVAL; PHASE 1 CLINICAL TRIAL; PHASE 3 CLINICAL TRIAL (TOPIC); PNEUMONIA; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RANDOMIZED CONTROLLED TRIAL; SKIN DISEASE; SURVIVAL RATE; SYSTEMIC THERAPY; TREATMENT DURATION; TUMOR VOLUME; CARCINOMA, NON-SMALL-CELL LUNG; CLINICAL TRIAL; COHORT ANALYSIS; KAPLAN MEIER METHOD; LUNG NEOPLASMS; METABOLISM; METASTASIS; MIDDLE AGED; TREATMENT OUTCOME; VERY ELDERLY;

ADULT; AGED; AGED, 80 AND OVER; ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC AGENTS; CARCINOMA, NON-SMALL-CELL LUNG; COHORT STUDIES; FEMALE; HUMANS; KAPLAN-MEIER ESTIMATE; LUNG NEOPLASMS; MALE; MIDDLE AGED; NEOPLASM METASTASIS; PROGRAMMED CELL DEATH 1 RECEPTOR; TREATMENT OUTCOME;

EID: 84936749833     PISSN: 0732183X     EISSN: 15277755     Source Type: Journal    
DOI: 10.1200/JCO.2014.58.3708     Document Type: Article

References (46)

1. Gettinger S, Lynch T: A decade of advances in treatment for advanced non-small cell lung cancer. Clin Chest Med 32:839-851, 2011
2. Socinski MA, Evans T, Gettinger S, et al: Treatment of stage IV non-small cell lung cancer: Diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest 143:e341S-e368S, 2013
3. Yang JC, Hirsh V, Schuler M, et al: Symptom control and quality of life in LUX-Lung 3: A phase III study of afatinib or cisplatin/pemetrexed in patients with advanced lung adenocarcinoma with EGFR mutations. J Clin Oncol 31:3342-3350, 2013
4. Kwak EL, Bang YJ, Camidge DR, et al: Anaplastic lymphoma kinase inhibition in non-small-cell lung cancer. N Engl J Med 363:1693-1703, 2010
5. Soria JC, Mauguen A, Reck M, et al: Systematic review and meta-analysis of randomised, phase II/III trials adding bevacizumab to platinum-based chemotherapy as first-line treatment in patients with advanced non-small-cell lung cancer. Ann Oncol 24:20-30, 2013
6. Dong H, Zhu G, Tamada K, et al: B7-H1, a third member of the B7 family, co-stimulates T-cell proliferation and interleukin-10 secretion. Nat Med 5:1365-1369, 1999
7. Freeman GJ, Long AJ, Iwai Y, et al: Engagement of the PD-1 immunoinhibitory receptor by a novel B7 family member leads to negative regulation of lymphocyte activation. J Exp Med 192:1027-1034, 2000
8. Dong H, Strome SE, Salomao DR, et al: Tumor-associated B7-H1 promotes T-cell apoptosis: A potential mechanism of immune evasion. Nat Med 8:793-800, 2002
9. Iwai Y, Ishida M, Tanaka Y, et al: Involvement of PD-L1 on tumor cells in the escape from host immune system and tumor immunotherapy by PD-L1 blockade. Proc Natl Acad Sci USA99:12293-12297, 2002
10. Topalian SL, Drake CG, Pardoll DM: Targeting the PD-1/B7-H1(PD-L1) pathway to activate anti-tumor immunity. Curr Opin Immunol 24:207-212, 2012
11. Wang C, Thudium KB, Han M, et al: In vitro characterization of the anti-PD-1 antibody nivolumab, BMS-936558, and in vivo toxicology in non-human primates Cancer Immunol Res 2:1-11, 2014
12. Topalian SL, Hodi FS, Brahmer JR, et al: Safety, activity, and immune correlates of anti-PD-1 antibody in cancer. N Engl J Med 366:2443-2454, 2012
13. Wolchok JD, Hoos A, O'Day S, et al: Guidelines for the evaluation of immune therapy activity in solid tumors: Immune-related response criteria. Clin Cancer Res 15:7412-7420, 2009
14. Therasse P, Arbuck SG, Eisenhauer EA, et al: New guidelines to evaluate the response to treatment in solid tumors: European Organisation for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst 92:205-216, 2000
15. Cancer Therapy Evaluation Program: Common Terminology Criteria for Adverse Events (version 3.0). http://ctep.cancer.gov/protocolDevelopment/electronic-applications/docs/ctcaev3.pdf
16. Topalian S, Sznol M, McDermott D, et al: Survival, durable tumor remission, and long-term safety in patients with advanced melanoma receiving nivolumab. J Clin Oncol 32:1020-1030, 2014
17. Oken MM, Creech RH, Tormey DC, et al: Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol 5:649-655, 1982
18. Marchetti A, Martella C, Felicioni L, et al: EGFR mutations in non-small-cell lung cancer: Analysis of a large series of cases and development of a rapid and sensitive method for diagnostic screening with potential implications on pharmacologic treatment. J Clin Oncol 23:857-865, 2005
19. Rekhtman N, Paik PK, Arcila ME, et al: Clarifying the spectrum of driver oncogene mutations in biomarker-verified squamous carcinoma of lung: Lack of EGFR/KRAS and presence of PIK3CA/AKT1 mutations. Clin Cancer Res 18:1167-1176, 2012
20. Dearden S, Stevens J, Wu YL, et al: Mutation incidence and coincidence in non small-cell lung cancer: Meta-analyses by ethnicity and histology (mutMap). Ann Oncol 24:2371-2376, 2013
21. Gettinger SN, Horn L, Gandhi L, et al: Long-term survival, clinical activity, and safety of nivolumab (Anti-PD-1; BMS-936558, ONO-4538) in patients (pts) with advanced non-small cell lung cancer (NSCLC). Intl J Radiat Oncol Biol Phys 90:5s, 2014 (suppl; abstr 170)
22. Hellmann, MD, Creelan BC, Woo K, et al: Smoking history and response to nivolumab in patients with advanced NSCLC. Ann Oncol 25:4s, 2014 (suppl; abstr 1229PD)
23. Topalian SL, Sznol M, Brahmer JR, et al: Nivolumab (anti-PD-1; BMS-936558; ONO-4538) in patients with advanced solid tumors: Survival and long-term safety in a phase I trial. J Clin Oncol 31:173s, 2013 (suppl 15s; abstr 3002)
24. Shepherd FA, Dancey J, Ramlau R, et al: Prospective randomized trial of docetaxel versus best supportive care in patients with non-small-cell lung cancer previously treated with platinum-based chemotherapy. J Clin Oncol 18:2095-2103, 2000
25. Hanna N, Shepherd FA, Fossella FV, et al: Randomized phase III trial of pemetrexed versus docetaxel in patients with non-small-cell lung cancer previously treated with chemotherapy. J Clin Oncol 22:1589-1597, 2004
26. Shepherd FA, Rodrigues PJ, Ciuleanu T, et al: Erlotinib in previously treated non-small-cell lung cancer. N Engl J Med 353:123-132, 2005
27. Girard N, Jacoulet P, Gainet M, et al: Third-line chemotherapy in advanced non-small cell lung cancer: Identifying the candidates for routine practice. J Thorac Oncol 4:1544-1549, 2009
28. Penrod JR, Korytowsky B, Petrilla A, et al: Survival of U.S. Medicare patients with advanced non-small cell lung cancer by line of therapy. J Clin Oncol 32:430s, 2014 (suppl 15s; abstr 6582)
29. American Society of Clinical Oncology: Institute for Quality: Practice guidelines. http://www.asco.org/quality-guidelines/guidelines
30. National Comprehensive Cancer Network: NCCN clinical practice guidelines in oncology: Non-small cell lung cancer (version 3.2014). http://www.nccn.org/professionals/physician-gls/f-guidelines.asp
31. Asahina H, Sekine I, Horinouchi H, et al: Retrospective analysis of third-line and fourth-line chemotherapy for advanced non-small-cell lung cancer. Clin Lung Cancer 13:39-43, 2012
32. Ramalingam S, Mazieres J, Planchard D, et al: Phase II study of nivolumab (anti-PD-1, BMS-936558, ONO-4538) in patients with advanced, refractory squamous non-small cell lung cancer. Intl J Rad Oncol Biol Physics 90:5s, 2014 (suppl; abstr LB2)
33. Garon EB, Gandhi L, Rizvi N, et al: Antitumor activity of pembrolizumab (pembro; MK-3475) and correlation with programmed death ligand 1 (PD-L1) expression in a pooled analysis of patients (pts) with advanced non-small cell lung. Ann Oncol 25:5s, 2014 (suppl; abstr LBA43)
34. Rizvi N, Shepherd FA, Antonia SJ, et al: Firstline monotherapy with nivolumab (Anti-PD-1; BMS-936558, ONO-4538) in advanced non-small cell lung cancer (NSCLC): Safety, efficacy, and correlation of outcomes with PD-L1 status. Intl J Rad Oncol Biol Biophys 90:5s, 2014 (suppl; abstr 165)
35. Horn L, Herbst R, Spiegel D, et al: An analysis of the relationship of clinical activity to baseline EGFR status, PD-L1 expression and prior treatment history in patients with non-small cell lung cancer (NSCLC) following PD-L1 blockade with MPDL3280A (anti-PDL1). Presented at the International Association for the Study of Lung Cancer 14th World Conference on Lung Cancer, Amsterdam, the Netherlands, July 3-7, 2011
36. Snyder A, Makarov V, Merghoub T, et al: Genetic basis for clinical response to CTLA-4 blockade in melanoma. N Engl J Med 371:2189-2199, 2014
37. Robert C, Long GV, Brady B, et al: Nivolumab in previously untreated melanoma without braf mutation. N Engl J Med 372:320-330, 2015
38. ClinicalTrials.gov: Study of BMS-936558 (nivolumab) compared to docetaxel in previously treated metastatic non-squamous NSCLC. http://clinicaltrials.gov/show/NCT01673867
39. ClinicalTrials.gov: Study of BMS-936558 (nivolumab) compared to docetaxel in previously treated advanced or metastatic squamous cell non-small cell lung cancer (NSCLC). http://clinicaltrials.gov/show/NCT01642004
40. ClinicalTrials.gov: Study of nivolumab (BMS-936558) in subjects with advanced or metastatic squamous cell non-small cell lung cancer who have received at least two prior systemic regimens. http://clinicaltrials.gov/show/NCT01721759
41. Gettinger S, Shepherd F, Antonia S, et al: First-line nivolumab (anti-PD-1; BMS-936558, ONO-4538) monotherapy in advanced NSCLC: Safety, efficacy, and correlation of outcomes with PD-L1 status. J Clin Oncol 32:512s, 2014 (suppl 15s; abstr 8024)
42. Herbst RS, Soria JC, Kowanetz M, et al: Predictive correlates of response to the anti-PD-L1 antibody MPDL3280A in cancer patients. Nature 515:563-567, 2014
43. ClinicalTrials.gov: An open-label, randomized, phase 3 trial of nivolumab versus investigator's choice chemotherapy as first-line therapy for stage IV or recurrent PD-L1+ non-small cell lung cancer. http://clinicaltrials.gov/show/NCT02041533
44. Brahmer J, Rizvi N, Lutzky J, et al: Clinical activity and biomarkers of MEDI4736, an anti-PD-L1 antibody, in patients with NSCLC. J Clin Oncol 32:511s, 2014 (suppl 15s; abstr 8021)
45. Garon E, Leighl N, Rizvi N, et al: Safety and clinical activity of MK-3475 in previously treated patients (pts) with non-small cell lung cancer (NSCLC). J Clin Oncol 32:511s, 2014 (suppl 15s; abstr 8020)
46. Rizvi N, Garon E, Patnaik A, et al: Safety and clinical activity of MK-3475 as initial therapy in patients with advanced non-small cell lung cancer (NSCLC). J Clin Oncol 32:507s, 2014 (suppl 15s; abstr 8007)