Phase III double-blind study comparing the efficacy and safety of proposed biosimilar MYL-1402O and reference bevacizumab in stage IV non-small-cell lung cancer

1. Torre, LA, Siegel, RL, Jemal, A. Lung cancer statistics. Adv Exp Med Biol 2016; 893: 1–19.
Google Scholar | Crossref | Medline2. Siegel, RL, Miller, KD, Jemal, A. Cancer statistics, 2020. CA Cancer J Clin 2020; 70: 7–30.
Google Scholar | Crossref | Medline3. Assoun, S, Brosseau, S, Steinmetz, C et al. Bevacizumab in advanced lung cancer: state of the art. Future Oncol 2017; 13: 2515–2535.
Google Scholar | Crossref | Medline4. Shroff, GS, de Groot, PM, Papadimitrakopoulou, VA et al. Targeted therapy and immunotherapy in the treatment of non-small cell lung cancer. Radiol Clin North Am 2018; 56: 485–495.
Google Scholar | Crossref | Medline5. Chen, R, Manochakian, R, James, L et al. Emerging therapeutic agents for advanced non-small cell lung cancer. J Hematol Oncol 2020; 13: 58.
Google Scholar | Crossref | Medline6. Janning, M, Loges, S. Anti-angiogenics: their value in lung cancer therapy. Oncol Res Treat 2018; 41: 172–180.
Google Scholar | Crossref | Medline7. Shukla, NA, Yan, MN, Hanna, N. The story of angiogenesis inhibitors in non-small-cell lung cancer: the past, present, and future. Clin Lung Cancer 2020; 21: 308–313.
Google Scholar | Crossref | Medline8. Garcia, J, Hurwitz, HI, Sandler, AB, et al. Bevacizumab (Avastin®) in cancer treatment: a review of 15 years of clinical experience and future outlook. Cancer Treat Rev 2020; 86: 102017.
Google Scholar | Crossref | Medline9. Sandler, A, Gray, R, Perry, MC, et al. Paclitaxel–carboplatin alone or with bevacizumab for non-small-cell lung cancer. N Engl J Med 2006; 355: 2542–2550.
Google Scholar | Crossref | Medline | ISI10. Cohen, MH, Gootenberg, J, Keegan, P, et al. FDA drug approval summary: bevacizumab (Avastin) plus carboplatin and paclitaxel as first-line treatment of advanced/metastatic recurrent nonsquamous non-small cell lung cancer. Oncologist 2007; 12: 713–718.
Google Scholar | Crossref | Medline | ISI11. Monk, BJ, Lammers, PE, Cartwright, T, et al. Barriers to the access of bevacizumab in patients with solid tumors and the potential impact of biosimilars: a physician survey. Pharmaceuticals (Basel) 2017; 10: 19.
Google Scholar | Crossref12. Melosky, B, Reardon, DA, Nixon, AB, et al. Bevacizumab biosimilars: scientific justification for extrapolation of indications. Future Oncol 2018; 14: 2507–2520.
Google Scholar | Crossref | Medline13. MVASITM (bevacizumab-awwb) injection [package insert] . Thousand Oaks, CA: Amgen. www.pi.amgen.com/~/media/amgen/repositorysites/pi-amgen-com/mvasi/mvasi_pi_hcp_english.pdf (2020, accessed 26 September 2020).
Google Scholar14. Thomas, M, Thatcher, N, Goldschmidt, J, et al. Totality of evidence in the development of ABP 215, an approved bevacizumab biosimilar. Immunotherapy 2019; 11: 1337–1351.
Google Scholar | Crossref | Medline15. Thatcher, N, Goldschmidt, JH, Thomas, M, et al. Efficacy and safety of the biosimilar ABP 215 compared with bevacizumab in patients with advanced nonsquamous non-small cell lung cancer (MAPLE): a randomized, double-blind, phase III study. Clin Cancer Res 2019; 25: 2088–2095.
Google Scholar | Crossref | Medline16. Hummel, M, Bosje, T, Shaw, A, et al. A pharmacokinetics study of proposed bevacizumab biosimilar MYL-1402O vs EU-bevacizumab and US-bevacizumab. J Cancer Res Clin Oncol. Epub ahead of print 17 April 2021. DOI: 10.1007/s00432-021-03628-0
Google Scholar | Crossref17. ZIRABEV, bevacizumab-bvzr injection, solution [package insert] . New York, NY: Pfizer Labs. http://labeling.pfizer.com/ShowLabeling.aspx?id=11860 (2020, accessed 26 September 2020).
Google Scholar18. Detterbeck, FC, Boffa, DJ, Kim, AW, et al. The eighth edition lung cancer stage classification. Chest 2017; 151: 193–203.
Google Scholar | Crossref | Medline19. Reinmuth, N, Bryl, M, Bondarenko, I, et al. PF-06439535 (a bevacizumab biosimilar) compared with reference bevacizumab (Avastin®), both plus paclitaxel and carboplatin, as first-line treatment for advanced non-squamous non-small-cell lung cancer: a randomized, double-blind study. BioDrugs 2019; 33: 555–570.
Google Scholar | Crossref | Medline20. AVASTIN® (bevacizumab) injection, for intravenous use [package insert] . South San Francisco, CA: Genentech Inc. www.gene.com/download/pdf/avastin_prescribing.pdf (2020, accessed 26 September 2020).
Google Scholar21. Johnson, DH, Fehrenbacher, L, Novotny, WF, et al. Randomized phase II trial comparing bevacizumab plus carboplatin and paclitaxel with carboplatin and paclitaxel alone in previously untreated locally advanced or metastatic non-small-cell lung cancer. J Clin Oncol 2004; 22: 2184–2191.
Google Scholar | Crossref | Medline | ISI22. European Medicines Agency . Guideline on similar biological medicinal products containing monoclonal antibodies – non-clinical and clinical issues, May 30, 2012. www.ema.europa.eu/en/documents/scientific-guideline/guideline-similar-biological-medicinal-products-containing-monoclonal-antibodies-non-clinical_en.pdf (2012, accessed 26 September 2020).
Google Scholar23. US Food and Drug Administration . Clinical trial endpoints for the approval of cancer drugs and biologics, Guidance for Industry. www.fda.gov/media/71195/download. (2018, accessed 26 September 2020).
Google Scholar24. Botrel, TEA, Clark, O, Clark, L, et al. Efficacy of bevacizumab (BEV) plus chemotherapy (CT) compared to CT alone in previously untreated locally advanced or metastatic non-small cell lung cancer (NSCLC): systematic review and meta-analysis. Lung Cancer 2011; 74: 89–97.
Google Scholar | Crossref | Medline25. Lima, ABC, Macedo, LT, Sasse, AD. Addition of bevacizumab to chemotherapy in advanced non-small cell lung cancer: a systematic review and meta-analysis. PLoS One 2011; 6: e22681.
Google Scholar | Crossref | Medline26. Soria, J-C, 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 2013; 24: 20–30.
Google Scholar | Crossref | Medline | ISI27. Han, S, Hong, Y, Liu, T, et al. The efficacy and safety of paclitaxel and carboplatin with versus without bevacizumab in patients with non-small-cell lung cancer: a systematic review and meta-analysis. Oncotarget 2018; 9: 14619–14629.
Google Scholar | Crossref | Medline28. Reck, M, Luft, A, Bondarenko, I, et al. A phase III, randomized, double-blind, multicenter study to compare the efficacy, safety, pharmacokinetics, and immunogenicity between SB8 (proposed bevacizumab biosimilar) and reference bevacizumab in patients with metastatic or recurrent nonsquamous non-small cell lung cancer. Lung Cancer 2020; 146: 12–18.
Google Scholar | Medline29. Yang, Y, Wu, B, Huang, L, et al. Biosimilar candidate IBI305 plus paclitaxel/carboplatin for the treatment of non-squamous non-small cell lung cancer. Transl Lung Cancer Res 2019; 8: 989–999.
Google Scholar | Crossref | Medline30. Reck, M, von Pawel, J, Zatloukal, P, et al. Overall survival with cisplatin–gemcitabine and bevacizumab or placebo as first-line therapy for nonsquamous non-small-cell lung cancer: results from a randomised phase III trial (AVAiL). Ann Oncol 2010; 21: 1804–1809.
Google Scholar | Crossref | Medline | ISI31. Niho, S, Kunitoh, H, Nokihara, H, et al. Randomized phase II study of first-line carboplatin–paclitaxel with or without bevacizumab in Japanese patients with advanced non-squamous non-small-cell lung cancer. Lung Cancer 2012; 76: 362–367.
Google Scholar | Crossref | Medline | ISI32. US Food and Drug Administration . FDA Briefing Document, Oncologic Drugs Advisory Committee, BLA 761028, ABP215, a proposed biosimilar to Avastin (bevacizumab). www.fda.gov/media/106528/download (2017, accessed 26 September 2020).
Google Scholar33. Planchard, D, Popat, S, Kerr, K, et al. ESMO Guidelines Committee. Metastatic non-small cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol 2018; 29 (Suppl. 4): iv192–iv237.
Google Scholar | Crossref | Medline34. National Comprehensive Cancer Network . Non-small cell lung cancer (version 6.2020). www.nccn.org/professionals/physician_gls/pdf/nscl.pdf (2020, accessed 26 September 2020).
Google Scholar

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