Tagrisso® (osimertinib)

TAGRISSO en monothérapie est indiqué dans :
- le traitement de première ligne des patients adultes atteints d’un cancer bronchique non à petites cellules (CBNPC) localement avancé ou métastatique avec mutations activatrices du récepteur du facteur de croissance épidermique (EGFR).
- le traitement des patients adultes atteints d’un CBNPC localement avancé ou métastatique, avec mutation EGFR T790M.

Références

  1. Résumé des charactéristiques du Tagrisso, version la plus récente.
  2. Mok TS, Wu YL, Ahn MJ, et al. Osimertinib or platinum-pemetrexed in EGFR T790M positive lung cancer [published online ahead of print December 6, 2016]. N Engl J Med. 2016. doi:10.1056/NEJMoa1612674.
  3. Data on File, 947230.011, AstraZeneca Pharmaceuticals LP.
  4. Yang J, Ramalingam S, Janne P, et al. Osimertinib (AZD9291) in pre-treated patients with T790M-positive advanced NSCLC: updated Phase l (Pl) and pooled Phase 2 (P2) results. Presented at: The European Lung Cancer Conference; April 2016; Geneva, Switzerland.
  5. Diaz LA Jr, Bardelli A. Liquid biopsies: genotyping circulating tumor DNA. J Clin Oncol. 2014;32:579-586.
  6. Jenkins S, Ramalingam S, Patel S, et al. Plasma ctDNA analysis for detection of EGFR T790M mutation in patients (pts) with EGFR mutation-positive advanced non-small cell lung cancer (aNSCLC). Presented at: The European Lung Cancer Conference; April 2016; Geneva, Switzerland.
  7. Schwaederle M, Husain H, Fanta PT, et al. Detection rate of actionable mutations in diverse cancers using a biopsy-free (blood) circulating tumor cell DNA assay. Oncotarget. 2016;7:9707-9717.
  8. Thress KS, Brant R, Carr TH, et al. EGFR mutation detection in ctDNA from NSCLC patient plasma: across-platform comparison of leading technologies to support the clinical development of AZD9291. Lung Cancer. 2015;90:509-515
  9. Cobas® EGFR Mutation Test v2 [package insert]. Indianapolis, IN: Roche Molecular Systems, Inc. 2016.
  10. Oxnard GR, Thress KS, Alden RS, et al. Association between plasma genotyping and outcomes of treatment with osimertinib (AZD9291) in advanced non-small-cell lung cancer. J Clin Oncol. 2016;34:3375-3382
  11. Redig AJ, Jänne PA. Basket trials and the evolution of clinical trial design in an era of genomic medicine. J Clin Oncol. 2015;33:975-978.
  12. Karlovich C, Goldman JW, Sun JM, et al. Assessment of EGFR mutation status in matched plasma and tumor tissue of NSCLC patients from a phase I study of rociletinib (CO-1686). Clin Cancer Res. 2016;22:2386-2395.
  13. Soria JC, Kim SW, Wu YL, et al. Gefitinib/chemotherapy vs chemotherapy in EGFR mutation-positive NSCLC resistant to first-line gefitinib: IMPRESS T790M subgroup analysis. J Thorac Oncol. 2015;10:S207-S208.
  14. Arcila ME, Oxnard GR, Nafa K, et al. Rebiopsy of lung cancer patients with acquired resistance to EGFR inhibitors and enhanced detection of the T790M mutation using a locked nucleic acid-based assay. Clin Cancer Res. 2011;17:1169-1180.
  15. Yu HA, Arcila ME, Rekhtman N, et al. Analysis of tumor specimens at the time of acquired resistance to EGFR-TKI therapy in 155 patients with EGFR-mutant lung cancers. Clin Cancer Res. 2013;19:2240-2247.
  16. Sun JM, Ahn MJ, Choi YL, et al. Clinical implications of T790M mutation in patients with acquired resistance to EGFR tyrosine kinase inhibitors. Lung Cancer. 2013;82:294-298.
  17. Sacher AG, Paweletz C, Dahlberg SE, et al. Prospective validation of rapid plasma genotyping for the detection of EGFR and KRAS mutations in advanced lung cancer. JAMA Oncol.  doi:l0.1001/jamaoncol.2016.0173.
  18. Lalkhen AG, McCluskey A. Clinical tests: sensitivity and specificity. Contin Educ Anaesth Crit Care Pain. 2008;8:221-223. doi:l0.1093/bjaceaccp/mkn04l NCCN, National Comprehensive Cancer Network.
  19. Langer CJ. Epidermal growth factor receptor inhibition in mutation-positive non-small-cell lung cancer: is afatinib better or simply newer? J Clin Oncol. 2013;3l:3303-3306
  20. Soria JC, Wu YL, Nakagawa K, et al. Gefitinib plus chemotherapy versus placebo plus chemotherapy in EGFR-mutation-positive non-small-cell lung cancer after progression on first-line gefitinib (IMPRESS): a phase 3 randomised trial. Lancet Oncol. 2015;16:990-998.
  21. Oxnard GR, Arcila ME, Sima CS, et al. Acquired resistance to EGFR tyrosine kinase inhibitors in EGFR-mutant lung cancer: distinct natural history of patients with tumors harboring the T790M mutation. Clin Cancer Res. 2011;17:1616-1622.
  22. Kuiper JL, Heideman DAM, Thunnissen E, et al. Incidence of T790M mutation in (sequential) rebiopsies in EGFR-mutated NSCLC-patients. Lung Cancer. 2014;85:19-24.
  23. Li W, Ren S, Li J, et al. T790M mutation is associated with better efficacy of treatment beyond progression with EGFR-TKI in advanced NSCLC patients. Lung Cancer. 2014;84:295-300.
  24. Cross DAE, Ashton SE, Ghiorghiu S, et al. AZD9291, an irreversible EGFR TKI, overcomes T790M-mediated resistance to EGFR inhibitors in lung cancer. Cancer Discov. 2014;4:1046-1061.
  25. Goss GD, Yang JCH, Ahn MJ, et al. AZD9291 in pre-treated patients with T790M positive advanced non-small cell lung cancer (NSCLC): pooled analysis from two phase II studies. Presented at: The European Cancer Congress; September 2015; Vienna, Austria.
  26. Goss G, Tsai C, Shephard F, et al. CNS response to osimertinib in patients with T790M-positive advanced NSCLC: pooled data from phase II trials. Presented at: 17th World Conference on Lung Cancer; December 4-7, 2016. Vienna, Austria.
  27. Data on File, 986,561.011, AstraZeneca Pharmaceuticals LP. Mok Osimertinib AURA3. Osimertinib or Platinum-Pemetrexed in EGFR T790M Positive Lung Cancer supplementary.Final.21Oct2016

NS ID XL-0228-RD01/2018-WEB