Benefit-risk summary of crizotinib for the treatment of patients with ROS1 alteration-positive, metastatic non-small cell lung cancer

Oncologist

Volumn 21, Issue 8, 2016, Pages 974-980

  Kazandjian, Dickran ^a   Blumenthal, Gideon M ^a   Luo, Lola ^a   He, Kun ^a   Fran, Ingrid ^a   Lemery, Steven ^a   Pazdur, Richard ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

Crizotinib; Non small cell lung cancer; ROS1; Tyrosine kinase inhibitor

Indexed keywords

CRIZOTINIB; ONCOPROTEIN; PROTEIN KINASE INHIBITOR; PROTEIN TYROSINE KINASE; PYRAZOLE DERIVATIVE; PYRIDINE DERIVATIVE; ROS1 PROTEIN, HUMAN;

ADULT; AGED; ARTICLE; BILE DUCT CARCINOMA; BRADYCARDIA; CLINICAL EVALUATION; CONSTIPATION; CONTROLLED STUDY; DECREASED APPETITE; DEMOGRAPHY; DIARRHEA; DIZZINESS; DYSGEUSIA; DYSPEPSIA; EDEMA; FATIGUE; FEMALE; FLUORESCENCE IN SITU HYBRIDIZATION; GENE MUTATION; GENE REARRANGEMENT; HUMAN; HYPOKALEMIA; HYPOPHOSPHATEMIA; INCIDENCE; LYMPHOCYTOPENIA; MAJOR CLINICAL STUDY; MALE; MIDDLE AGED; NAUSEA; NEUTROPENIA; NON SMALL CELL LUNG CANCER; OUTCOME ASSESSMENT; OVERALL SURVIVAL; PRIORITY JOURNAL; RASH; REVERSE TRANSCRIPTION POLYMERASE CHAIN REACTION; SIGNAL TRANSDUCTION; VOMITING; CLINICAL TRIAL; FOOD AND DRUG ADMINISTRATION; GENETICS; METASTASIS; MULTICENTER STUDY; PATHOLOGY; RISK ASSESSMENT; UNITED STATES;

ADULT; AGED; CARCINOMA, NON-SMALL-CELL LUNG; FEMALE; GENE REARRANGEMENT; HUMANS; MALE; MIDDLE AGED; NEOPLASM METASTASIS; PROTEIN KINASE INHIBITORS; PROTEIN-TYROSINE KINASES; PROTO-ONCOGENE PROTEINS; PYRAZOLES; PYRIDINES; RISK ASSESSMENT; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84981515990     PISSN: 10837159     EISSN: 1549490X     Source Type: Journal    
DOI: 10.1634/theoncologist.2016-0101     Document Type: Article

References (55)

1. American Cancer Society. Cancer Facts & Figures 2016. Atlanta, GA: American Cancer Society, 2016
2. Schiller JH, Gandara DR, Goss GD et al. Nonsmall-cell lung cancer: Then and now. J Clin Oncol 2013;31:981-983
3. 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 2000;18:2095-2103
4. Rizvi NA, Hellmann MD, Snyder A et al. Cancer immunology. Mutational landscape determines sensitivity to PD-1 blockade in non-small cell lung cancer. Science 2015;348:124-128
5. 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 2004;22: 1589-1597
6. Shepherd FA, Rodrigues Pereira J, Ciuleanu T et al. Erlotinib in previously treated non-smallcell lung cancer. N Engl J Med 2005;353: 123-132
7. Oxnard GR, Binder A, J¨anne PA. New targetable oncogenes in non-small-cell lung cancer. J Clin Oncol 2013;31:1097-1104
8. Garon EB, Rizvi NA, Hui R et al. Pembrolizumab for the treatment of non-small-cell lung cancer. N Engl JMed 2015;372:2018-2028
9. Harvey RD. Immunologic and clinical effects of targeting PD-1 in lung cancer. Clin Pharmacol Ther 2014;96:214-223
10. Herbst RS, Baas P, Kim D-W et al. Pembrolizumab versusdocetaxel forpreviously treated,PD-L1-positive, advanced non-small-cell lung cancer (Keynote-010): A randomised controlled trial. Lancet 2016;387: 1540-1550
11. Langer CJ. Emerging immunotherapies in the treatment of non-small cell lung cancer (NSCLC):The role of immune checkpoint inhibitors. Am J Clin Oncol 2015;38:422-430
12. Borghaei H, Paz-Ares L, Horn L et al. Nivolumab versusdocetaxel inadvancednonsquamousnon-smallcell lung cancer. N Engl JMed 2015;373:1627-1639
13. Brahmer J, Reckamp KL, Baas P et al. Nivolumab versusdocetaxel inadvancedsquamous-cellnon-smallcell lung cancer. N Engl JMed 2015;373:123-135
14. Kazandjian D, Khozin S, Blumenthal G et al. Benefit-risk summary of nivolumab for patients with metastatic squamous cell lung cancer after platinumbased chemotherapy: A report fromthe U.S. Food and Drug Administration. JAMA Oncol 2016;2:118-122
15. Rizvi NA, Mazières J, Planchard D et al. Activity and safety of nivolumab, an anti-PD-1 immune checkpoint inhibitor, for patients with advanced, refractory squamous non-small-cell lung cancer (CheckMate 063): A phase 2, single-arm trial. Lancet Oncol 2015;16:257-265
16. Li T, Kung HJ, Mack PC et al. Genotyping and genomic profiling of non-small-cell lung cancer: Implications for current and future therapies. J Clin Oncol 2013;31:1039-1049
17. Schettino C, Bareschino MA, Sacco PC et al. New molecular targets in the treatment of NSCLC. Curr Pharm Des 2013;19:5333-5343
18. Shames DS, Wistuba II. The evolving genomic classification of lungcancer. JPathol2014;232:121-133
19. Pao W, Girard N. New driver mutations in nonsmall-cell lung cancer. Lancet Oncol 2011;12:175-180
20. Johnson BE, Kris MG, Berry LD et al. A multicenter effort to identify driver mutations and employ targeted therapy in patients with lung adenocarcinomas: The lung cancer mutation consortium (LCMC). J Clin Oncol 2013;31:8019a
21. Kohno T, Nakaoku T, Tsuta K et al. Beyond ALKRET, ROS1 and other oncogene fusions in lung cancer. Transl Lung Cancer Res 2015;4:156-164
22. Cancer Genome Atlas Research Network. Comprehensive molecular profiling of lung adenocarcinoma [published corrections appears in Nature 2014;514:262]. Nature 2014;511:543-550
23. Acquaviva J, Wong R, Charest A. The multifaceted roles of the receptor tyrosine kinase ROS in development and cancer. Biochim Biophys Acta 2009;1795:37-52
24. Rikova K, Guo A, Zeng Q et al. Global survey of phosphotyrosine signaling identifies oncogenic kinases in lung cancer. Cell 2007;131:1190-1203
25. Birchmeier C, O’Neill K, Riggs M et al. Characterization ofROS1cDNAfromahumanglioblastoma cell line. ProcNatlAcad SciUSA1990;87:4799-4803
26. Birchmeier C, Sharma S, Wigler M. Expression and rearrangement of the ROS1 gene in human glioblastoma cells. Proc Natl Acad Sci USA 1987;84: 9270-9274
27. Davies KD, Doebele RC. Molecular pathways: ROS1 fusion proteins in cancer.Clin Cancer Res2013; 19:4040-4045
28. Stumpfova M, Jänne PA. Zeroing in on ROS1 rearrangements in non-small cell lung cancer. Clin Cancer Res 2012;18:4222-4224
29. Bos M, Gardizi M, Schildhaus H-U et al. Activated RET and ROS: Two new driver mutations in lung adenocarcinoma. Transl Lung Cancer Res 2013;2: 112-121
30. Shaw AT, Ou S-HI, Bang Y-J et al. Crizotinib in ROS1-rearranged non-small-cell lung cancer. N Engl J Med 2014;371:1963-1971
31. Ou S-HI, Chalmers ZR, Azada MC et al. Identification of a novel TMEM106B-ROS1 fusion variant in lung adenocarcinoma by comprehensive genomic profiling. Lung Cancer 2015;88:352-354
32. Shaw AT, Hsu PP, Awad MM et al. Tyrosine kinase gene rearrangements in epithelial malignancies. Nat Rev Cancer 2013;13:772-787
33. Charest A, Lane K, McMahon K et al. Fusion of FIG to the receptor tyrosine kinase ROS in a glioblastoma with an interstitial del(6)(q21q21). Genes Chromosomes Cancer 2003;37:58-71
34. Gu T-L, Deng X, Huang F et al. Survey of tyrosine kinase signaling revealsROSkinase fusions inhuman cholangiocarcinoma. PLoS One 2011;6:e15640
35. Bergethon K, Shaw AT, Ou SH et al. ROS1 rearrangements define a unique molecular class of lung cancers. J Clin Oncol 2012;30:863-870
36. Takeuchi K, Soda M, Togashi Y et al.RET,ROS1 and ALK fusions in lung cancer. Nat Med 2012;18:378-381
37. Davies KD, Le AT, Theodoro MF et al. IdentifyingandtargetingROS1genefusions innon-small cell lung cancer. Clin Cancer Res 2012;18:4570-4579
38. Ou S-HI, Bang Y-J, Camidge DR et al. Efficacy and safety of crizotinib in patients with advanced ROS1-rearranged non-small cell lung cancer (NSCLC). J Clin Oncol 2013;31:8032a
39. Mazières J, Zalcman G, Crinò L et al. Crizotinib therapy for advanced lung adenocarcinoma and a ROS1 rearrangement: Results from the EUROS1 cohort. J Clin Oncol 2015;33:992-999
40. Moro-Sibilot D, Faivre L, Zalcman G et al. Crizotinib in patients with advanced ROS1-rearranged non-small cell lung cancer (NSCLC). Preliminary results of the ACSé phase II trial. J Clin Oncol 2015;33:8065a
41. Malik SM, Maher VE, Bijwaard KE et al. U.S. Food and Drug Administration approval: Crizotinib for treatment of advanced or metastatic non-small cell lung cancer that is anaplastic lymphoma kinase positive. Clin Cancer Res 2014;20:2029-2034
42. Kwak EL, Bang Y-J, Camidge DR et al. Anaplastic lymphoma kinase inhibition in non-small-cell lung cancer. N Engl J Med 2010;363:1693-1703
43. Crino L, Kim D, Riely G et al. Initial phase II results with crizotinib in advanced ALK-positive nonsmall cell lung cancer (NSCLC): Profile 1005. J Clin Oncol 2011;29:7514a
44. Shaw AT, Kim D-W, Nakagawa K et al. Crizotinib versuschemotherapy in advanced ALK-positive lung cancer. N Engl J Med 2013;368:2385-2394
45. Kazandjian D, Blumenthal GM, Chen HY et al. FDA approval summary: Crizotinib for the treatment of metastatic non-small cell lung cancer with anaplastic lymphoma kinase rearrangements. The Oncologist 2014;19:e5-e11
46. Solomon BJ, Mok T, Kim D-W et al. First-line crizotinib versus chemotherapy in ALK-positive lung cancer. N Engl J Med 2014;371:2167-2177
47. Shaw AT, Camidge DR, Engelman JA et al. Clinical activity of crizotinib in advanced non-small cell lung cancer (NSCLC) harboring ROS1 gene rearrangement. J Clin Oncol 2012;30:7508a
48. Camidge DR, Bang Y-J, Kwak EL et al. Activity and safety of crizotinib in patients with ALK-positive nonsmall-cell lung cancer: Updated results from a phase 1 study. Lancet Oncol 2012;13:1011-1019
49. National Institutes of Health. Crizotinib US product insert. Available at http://dailymed.nlm. nih.gov/dailymed/drugInfo.cfm?setid52a51b0de-47d6-455e-a94c-d2c737b04ff7. Accessed February 27, 2016
50. Blumenthal GM, Karuri SW, Zhang H et al. Overall response rate, progression-free survival, and overall survival with targeted and standard therapies in advanced non-small-cell lung cancer: US Food and Drug Administration trial-level and patient-level analyses. J Clin Oncol 2015;33: 1008-1014
51. Simon R, Blumenthal GM, Rothenberg ML et al. The role of nonrandomized trials in the evaluation of oncology drugs. Clin Pharmacol Ther 2015;97:502-507
52. Blumenthal GM, Pazdur R. Response rate as an approval end point in oncology: Back to the future. JAMA Oncol 2016 (in press)
53. Food and Drug Administration. In vitro companion diagnostic devices guidance for industry and Food and Drug Administration staff. Available at http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ ucm262327.pdf. Accessed February 27, 2016
54. Complexities in personalized medicine: Harmonizing companion diagnostics across a class of targeted therapies; 2015. Available at http://www.aacr.org/advocacypolicy/governmentaffairs/pages/complexities-in-personalized-medicine.aspx. Accessed December 3, 2015
55. Crescenzo R and Inghirami G. Anaplastic lymphoma kinase inhibitors. Curr Opin Pharmacol 2015;23:39-44.