9,871
Views
32
CrossRef citations to date
0
Altmetric
Drug Evaluation

Tislelizumab: an investigational anti-PD-1 antibody for the treatment of advanced non-small cell lung cancer (NSCLC)

&
Pages 1355-1364 | Received 03 Aug 2020, Accepted 05 Oct 2020, Published online: 21 Oct 2020

References

  • Bray F, Ferlay J, Soerjomataram I, et al. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394–424.
  • D’Addario G, Fruh M, Reck M, et al. Metastatic non-small-cell lung cancer: ESMO clinical practice guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2010 May;21(suppl 5):v116–119.
  • Blandin Knight S, Crosbie PA, Balata H, et al. Progress and prospects of early detection in lung cancer. Open Biol. 2017 Sep;7(9):170070.
  • Smida T, Bruno TC, Stabile LP. Influence of estrogen on the NSCLC microenvironment: a comprehensive picture and clinical implications. Front Oncol. 2020;10:137.
  • Akinleye A, Rasool Z. Immune checkpoint inhibitors of PD-L1 as cancer therapeutics. J Hematol Oncol. 2019 Sep 5;12(1):92.
  • McDermott DF, Atkins MB. PD-1 as a potential target in cancer therapy. Cancer Med. 2013 Oct;2(5):662–673.
  • Weber J. Overcoming immunologic tolerance to melanoma: targeting CTLA-4 with ipilimumab (MDX-010). Oncologist. 2008;13(suppl 4):16–25.
  • Thallinger C, Fureder T, Preusser M, et al. Review of cancer treatment with immune checkpoint inhibitors: current concepts, expectations, limitations and pitfalls. Wien Klin Wochenschr. 2018 Feb;130(3–4):85–91.
  • 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 Apr 9;387(10027):1540–1550.
  • Peters S, Gettinger S, Johnson ML, et al. Phase II trial of atezolizumab as first-line or subsequent therapy for patients with programmed death-ligand 1-selected advanced non-small-cell lung cancer (BIRCH). J Clin Oncol. 2017 Aug 20;35(24):2781–2789.
  • Spigel DR, Chaft JE, Gettinger S, et al. FIR: efficacy, safety, and biomarker analysis of a phase II open-label study of atezolizumab in PD-L1-selected patients with NSCLC. J Thorac Oncol. 2018 Nov;13(11):1733–1742.
  • Brahmer J, Reckamp KL, Baas P, et al. Nivolumab versus docetaxel in advanced squamous-cell non-small-cell lung cancer. N Engl J Med. 2015 Jul 9;373(2):123–135.
  • 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 Oct 22;373(17):1627–1639.
  • Antonia SJ, Villegas A, Daniel D, et al. Overall survival with durvalumab after chemoradiotherapy in stage III NSCLC. N Engl J Med. 2018 Dec 13;379(24):2342–2350.
  • Gettinger S, Rizvi NA, Chow LQ, et al. Nivolumab monotherapy for first-line treatment of advanced non-small-cell lung cancer. J Clin Oncol. 2016 Sep 1;34(25):2980–2987.
  • Shi Y, Sun Y, Yu J, et al. China experts consensus on the diagnosis and treatment of advanced stage primary lung cancer (2016 version). Asia Pac J Clin Oncol. 2017 Feb;13(1):87–103.
  • Horn L, Mansfield AS, Szczesna A, et al. First-line atezolizumab plus chemotherapy in extensive-stage small-cell lung cancer. N Engl J Med. 2018 Dec 6;379(23):2220–2229.
  • Paz-Ares L, Luft A, Vicente D, et al. Pembrolizumab plus chemotherapy for squamous non-small-cell lung cancer. N Engl J Med. 2018 Nov 22;379(21):2040–2051.
  • Gandhi L, Rodriguez-Abreu D, Gadgeel S, et al. Pembrolizumab plus chemotherapy in metastatic non-small-cell lung cancer. N Engl J Med. 2018 May 31;378(22):2078–2092.
  • Reck M, Rodriguez-Abreu D, Robinson AG, et al. Updated analysis of KEYNOTE-024: pembrolizumab versus platinum-based chemotherapy for advanced non-small-cell lung cancer with PD-L1 tumor proportion score of 50% or greater. J Clin Oncol. 2019 Mar 1;37(7):537–546.
  • Mok TSK, Wu YL, Kudaba I, et al. Pembrolizumab versus chemotherapy for previously untreated, PD-L1-expressing, locally advanced or metastatic non-small-cell lung cancer (KEYNOTE-042): a randomised, open-label, controlled, phase 3 trial. Lancet. 2019 May 4;393(10183):1819–1830.
  • Mountzios G, Remon J, Novello S, et al. Position of an international panel of lung cancer experts on the decision for expansion of approval for pembrolizumab in advanced non-small-cell lung cancer with a PD-L1 expression level of >/=1% by the USA food and drug administration. Ann Oncol. 2019 Nov 1;30(11):1686–1688.
  • Carbone DP, Reck M, Paz-Ares L, et al. First-line nivolumab in stage IV or recurrent non-small-cell lung cancer. N Engl J Med. 2017 Jun 22;376(25):2415–2426.
  • Spigel D, de Marinis F, Giaccone G, et al. IMpower110: interim overall survival analysis of a phase III study of atezolizumab vs platinum-based chemotherapy as first-line treatment in PD-L1-selected NSCLC. Ann Oncol. 2019;30(suppl 5):v851–934.
  • Rizvi NA, Cho BC, Reinmuth N, et al. Durvalumab with or without tremelimumab vs standard chemotherapy in first-line treatment of metastatic non-small cell lung cancer: the MYSTIC phase 3 randomized clinical trial. JAMA Oncol. 2020 May 1;6(5):661–674.
  • Reck M, Ciuleanu TE, Cobo Dols M, et al. Nivolumab (NIVO) + ipilimumab (IPI) + 2 cycles of platinum-doublet chemotherapy (chemo) vs 4 cycles chemo as first-line (1L) treatment (tx) for stage IV/recurrent non-small cell lung cancer (NSCLC): checkMate 9LA. J Clin Oncol. 2020;38(suppl):Abstract 9501.
  • Gadgeel S, Rodriguez-Abreu D, Speranza G, et al. Updated analysis from KEYNOTE-189: pembrolizumab or placebo plus pemetrexed and platinum for previously untreated metastatic nonsquamous non-small-cell lung cancer. J Clin Oncol. 2020 May 10;38(14):1505–1517.
  • Socinski MA, Jotte RM, Cappuzzo F, et al. Atezolizumab for first-line treatment of metastatic nonsquamous NSCLC. N Engl J Med. 2018 Jun 14;378(24):2288–2301.
  • West H, McCleod M, Hussein M, et al. Atezolizumab in combination with carboplatin plus nab-paclitaxel chemotherapy compared with chemotherapy alone as first-line treatment for metastatic non-squamous non-small-cell lung cancer (IMpower130): a multicentre, randomised, open-label, phase 3 trial. Lancet Oncol. 2019 Jul;20(7):924–937.
  • Jotte R, Cappuzzo F, Vynnychenko I, et al. Atezolizumab in combination with carboplatin and nab-paclitaxel in advanced squamous NSCLC (IMpower131): results from a randomized phase III trial. J Thorac Oncol. 2020 Apr 14;S1556–0864(20):30292–30296.
  • Zhang T, Song X, Xu L, et al. The binding of an anti-PD-1 antibody to FcgammaRIota has a profound impact on its biological functions. Cancer Immunol Immunother. 2018 Jul;67(7):1079–1090.
  • Dahan R, Sega E, Engelhardt J, et al. FcγRs modulate the anti-tumor activity of antibodies targeting the PD-1/PD-L1 axis. Cancer Cell. 2015 Sep 14;28(3):285–295.
  • Feng Y, Hong Y, Sun H, et al. The molecular binding mechanism of tislelizumab, an investigational anti-PD-1 antibody, is differentiated from pembrolizumab and nivolumab. Proceedings of the 110th Annual Meeting of the American Association for Cancer Research. Atlanta, GA: American Association of Cancer Research; 2019. p. Abstract 4048.
  • Kaplon H, Reichert JM. Antibodies to watch in 2019. MAbs. 2019 Feb/Mar;11(2):219–238.
  • Patnaik A, Kang SP, Rasco D, et al. Phase I study of pembrolizumab (MK-3475; anti-PD-1 monoclonal antibody) in patients with advanced solid tumors. Clin Cancer Res. 2015 Oct 1;21(19):4286–4293.
  • Topalian SL, Hodi FS, Brahmer JR, et al. Safety, activity, and immune correlates of anti-PD-1 antibody in cancer. N Engl J Med. 2012 Jun 28;366(26):2443–2454.
  • Lee A, Keam SJ. Tislelizumab: first approval. Drugs. 2020 Mar 18;80(6):617–624.
  • Desai J, Markman B, Sandhu S, et al. Updated safety, efficacy, and pharmacokinetics (PK) results from the phase I study of BGB-A317, an anti- programmed death-1 (PD-1) mAb in patients with advanced solid tumors. J Immunother Cancer. 2016;4(Suppl1):AbstractP154.
  • Wu C-Y, Tang T, Liu L, et al. Population pharmacokinetics of tislelizumab in patients with advanced tumors. Ann Oncol. 2019;30(suppl 5):183.
  • Desai J, Deva S, Lee JS, et al. Phase IA/IB study of single-agent tislelizumab, an investigational anti-PD-1 antibody, in solid tumors. J Immunother Cancer. 2020 Jun;8(1):e000453.
  • Barlow P, Jameson M, Lin -C-C, et al. Single-agent tislelizumab, an anti-PD-1 antibody: results from a phase 1 expansion cohort in NSCLC patients.Poster presented at: the 20th World Congress on Lung Cancer; September 07–10, 2019; Barcelona, Spain.
  • Shen L, Guo J, Zhang Q, et al. Tislelizumab in Chinese patients with advanced solid tumors: an open-label, non-comparative, phase 1/2 study. J Immunother Cancer. 2020 Jun;8:1.
  • Wang Z, Zhao J, Ma Z, et al. A phase 2 study of tislelizumab in combination with platinum-based chemotherapy as first-line treatment for advanced lung cancer in chinese patients. Lung Cancer. 2020 Sep;147:259–268.
  • Wang J, Lu S, Hu C et al. Updated analysis of tislelizumab plus chemotherapy vs chemotherapy alone as first-line treatment of advanced squamous non-small cell lung cancer (SQ NSCLC). Presented at: 2020 European Society for Medical Oncology Meeting; 19–21 September, 2020; Virtual Congress.
  • BeiGene announces that the phase 3 trial of tislelizumab combined with chemotherapy in patients with first-line non-squamous non-small cell lung cancer met the primary endpoint of progression-free survival at interim analysis. [cited 2020 Jul 09]. Available from: http://ir.beigene.com/news-releases/news-release-details/beigene-announces-phase-3-trial-tislelizumab-combined
  • Hellmann MD, Ciuleanu TE, Pluzanski A, et al. Nivolumab plus ipilimumab in lung cancer with a high tumor mutational burden. N Engl J Med. 2018 May 31;378(22):2093–2104.
  • Wang C, Liang H, Lin C, et al. Molecular subtyping and prognostic assessment based on tumor mutation burden in patients with lung adenocarcinomas. Int J Mol Sci. 2019 Aug 30;20(17):4251.
  • Wu Y, Xu J, Du C, et al. The predictive value of tumor mutation burden on efficacy of immune checkpoint inhibitors in cancers: a systematic review and meta-analysis. Front Oncol. 2019;9:1161.
  • Gandara DR, Paul SM, Kowanetz M, et al. Blood-based tumor mutational burden as a predictor of clinical benefit in non-small-cell lung cancer patients treated with atezolizumab. Nat Med. 2018 Sep;24(9):1441–1448.
  • Abbosh C, Birkbak NJ, Swanton C. Early stage NSCLC - challenges to implementing ctDNA-based screening and MRD detection. Nat Rev Clin Oncol. 2018 Sep;15(9):577–586.