Pembrolizumab for the first-line treatment of non-small cell lung cancer

References

• Sweis RF, Luke JJ. Mechanistic and pharmacologic insights on immune checkpoint inhibitors. Pharmacol Res. 2017;120:1–9.
   PubMed Web of Science ®Google Scholar
• Chen DS, Mellman I. Elements of cancer immunity and the cancer-immune set point. Nature. 2017;541:321–330.
   PubMed Web of Science ®Google Scholar
• Disis ML. Mechanism of action of immunotherapy. Semin Oncol. 2014;41(Suppl 5):S3–13.
   PubMed Web of Science ®Google Scholar
• Hotta K, Matsuo K, Ueoka H, et al. Meta-analysis of randomized clinical trials comparing cisplatin to carboplatin in patients with advanced non-small-cell lung cancer. J Clin Oncol. 2004;22:3852–3859.
   PubMed Web of Science ®Google Scholar
• Hotta K, Matsuo K, Ueoka H, et al. Addition of platinum compounds to a new agent in patients with advanced non-small-cell lung cancer: a literature based meta-analysis of randomised trials. Ann Oncol. 2004;15:1782–1789.
   PubMed Web of Science ®Google Scholar
• Hotta K, Matsuo K. Long-standing debate on cisplatin- versus carboplatin-based chemotherapy in the treatment of advanced non-small-cell lung cancer. J Thorac Oncol. 2007;2:96.
   PubMed Web of Science ®Google Scholar
• Hotta K, Fujiwara Y, Matsuo K, et al. Recent improvement in the survival of patients with advanced non small cell lung cancer enrolled in phase III trials of first-line, systemic chemotherapy. Cancer. 2007;109:939–948.
   PubMed Web of Science ®Google Scholar
• Hotta K, Takigawa N, Hisamoto-Sato A, et al. Reappraisal of short-term low-volume hydration in cisplatin-based chemotherapy: results of a prospective feasibility study in advanced lung cancer in the okayama lung cancer study group trial 1002. Jpn J Clin Oncol. 2013;43:1115–1123.
   PubMed Web of Science ®Google Scholar
• Ninomiya K, Hotta K, Hisamoto-Sato A, et al. Short-term low-volume hydration in cisplatin-based chemotherapy for patients with lung cancer: the second prospective feasibility study in the okayama lung cancer study group trial 1201. Int J Clin Oncol. 2016;21:81–87.
   PubMed Web of Science ®Google Scholar
• Hotta K, Kiura K, Toyooka S, et al. Clinical significance of epidermal growth factor receptor gene mutations on treatment outcome after first-line cytotoxic chemotherapy in Japanese patients with non-small-cell lung cancer. J Thorac Oncol. 2007;2:632–637.
   PubMed Web of Science ®Google Scholar
• Hotta K, Ninomiya K, Takigawa N, et al. Reappraisal of short-term low-volume hydration in cisplatin-based chemotherapy; hoping for it as a public domain. Jpn J Clin Oncol. 2015;45:603–604.
   PubMed Web of Science ®Google Scholar
• Tumeh PC, Harview CL, Yearley JH, et al. PD-1 blockade induces responses by inhibiting adaptive immune resistance. Nature. 2014;515:568–571.
   PubMed Web of Science ®Google Scholar
• Robert C, Ribas A, Wolchok JD, et al. Anti-programmed-death-receptor-1 treatment with pembrolizumab in ipilimumab-refractory advanced melanoma: a randomised dose-comparison cohort of a phase 1 trial. Lancet. 2014;384:1109–1117.
   PubMed Web of Science ®Google Scholar
• Seiwert TY, Burtness B, Mehra R, et al. Safety and clinical activity of pembrolizumab for treatment of recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-012): an open-label, multicentre, phase 1b trial. Lancet Oncol. 2016;17:956–965.
   PubMed Web of Science ®Google Scholar
• Chen R, Zinzani PL, Fanale MA, et al. Phase II study of the efficacy and safety of pembrolizumab for relapsed/refractory classic Hodgkin lymphoma. J Clin Oncol. 2017;35:2125–2132.
   PubMed Web of Science ®Google Scholar
• Balar AV, Castellano D, O’Donnell PH, et al. First-line pembrolizumab in cisplatin-ineligible patients with locally advanced and unresectable or metastatic urothelial cancer (KEYNOTE-052): a multicentre, single-arm, phase 2 study. Lancet Oncol. 2017;18:1483–1492.
   PubMed Web of Science ®Google Scholar
• Fuchs CS, Doi T, Jang RW, et al. Safety and efficacy of pembrolizumab monotherapy in patients with previously treated advanced gastric and gastroesophageal junction cancer: phase 2 clinical KEYNOTE-059 trial. JAMA Oncol. 2018; 4(5):e180013. Mar 15. [Epub ahead of print].
   PubMed Web of Science ®Google Scholar
• Le DT, Durham JN, Smith KN, et al. Mismatch repair deficiency predicts response of solid tumors to PD-1 blockade. Science. 2017;357:409–413.
   PubMed Web of Science ®Google Scholar
• 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;387:1540–1550.
   PubMed Web of Science ®Google Scholar
• Lim SH, Sun JM, Lee SH, et al. Pembrolizumab for the treatment of non-small cell lung cancer. Expert Opin Biol Ther. 2016;16:397–406.
   PubMed Web of Science ®Google Scholar
• Gridelli C, Ascierto PA, Barberis MC, et al. Immunotherapy of non-small cell lung cancer: report from an international experts panel meeting of the Italian association of thoracic oncology. Expert Opin Biol Ther. 2016;16:1479–1489.
   PubMed Web of Science ®Google Scholar
• Sgambato A, Casaluce F, Gridelli C. The role of checkpoint inhibitors immunotherapy in advanced non-small cell lung cancer in the elderly. Expert Opin Biol Ther. 2017;17:565–571.
   PubMed Web of Science ®Google Scholar
• Garon EB, Rizvi NA, Hui R, et al. Pembrolizumab for the treatment of non-small-cell lung cancer. New Engl J Med. 2015;372:2018–2028.
   PubMed Web of Science ®Google Scholar
• Hui R, Garon EB, Goldman JW, et al. Pembrolizumab as first-line therapy for patients with PD-L1-positive advanced non-small cell lung cancer: a phase 1 trial. Ann Oncol. 2017;28:874–881.
   PubMed Web of Science ®Google Scholar
• Reck M, Rodríguez-Abreu D, Robinson AG, et al. Pembrolizumab versus chemotherapy for PD-L1-positive non-small-cell lung cancer. N Engl J Med. 2016;375:1823–1833.
   PubMed Web of Science ®Google Scholar
• Reck M, Rodriguez-Abreu D, Robinson AG, et al. Updated analysis of KEYNOTE-024: pembrolizumab vs platinum-based chemotherapy for advanced non-small-cell lung cancer with PD-L1 tumor proportion score ≥ 50%. J Clin Oncol. 2018 (in press)
   Google Scholar
• Brahmer JR, Rodríguez-Abreu D, Robinson AG, et al. Health-related quality-of-life results for pembrolizumab versus chemotherapy in advanced, PD-L1-positive NSCLC (KEYNOTE-024): a multicentre, international, randomised, open-label phase 3 trial. Lancet Oncol. 2017;18:1600–1609.
   PubMed Web of Science ®Google Scholar
• Lopes G, Wu YL, Kudaba I, et al. Pembrolizumab (pembro) versus platinum-based chemotherapy (chemo) as first-line therapy for advanced/metastatic NSCLC with a PD-L1 tumor proportion score (TPS) ≥ 1%: open-label, phase 3 KEYNOTE-042 study. J Clin Oncol. 2018; 38(15_suppl):LBA4
   Google Scholar
• Zitvogel L, Galluzzi L, Smyth MJ, et al. Mechanism of action of conventional and targeted anticancer therapies: reinstating immunosurveillance. Immunity. 2013;39:74–88.
   PubMed Web of Science ®Google Scholar
• Galluzzi L, Buqué A, Kepp O, et al. Immunological effects of conventional chemotherapy and targeted anticancer agents. Cancer Cell. 2015;28:690–714.
   PubMed Web of Science ®Google Scholar
• Emens LA, Middleton G. The interplay of immunotherapy and chemotherapy: harnessing potential synergies. Cancer Immunol Res. 2015;3:436–443.
   PubMed Web of Science ®Google Scholar
• Gadgeel SM, Stevenson J, Langer CJ, et al. Pembrolizumab (pembro) plus chemotherapy as front-line therapy for advanced NSCLC: KEYNOTE-021 cohorts A-C. J Clin Oncol. 2016;34(15_suppl):9016.
   Google Scholar
• Langer CJ, Gadgeel SM, Borghaei H, et al. Carboplatin and pemetrexed with or without pembrolizumab for advanced, non-squamous non-small-cell lung cancer: a randomised, phase 2 cohort of the open-label KEYNOTE-021 study. Lancet Oncol. 2016;17:1497–1508.
   PubMed Web of Science ®Google Scholar
• Gandhi L, Rodríguez-Abreu D, Gadgeel S, et al. Pembrolizumab plus chemotherapy in metastatic non-small-cell lung cancer. N Engl J Med. 2018 Apr 16; [Epub ahead of print];378:2078–2092.
   PubMed Web of Science ®Google Scholar
• Paz-Ares LG, Luft A, Tafreshi A, et al. Phase 3 study of carboplatin-paclitaxel/nab-paclitaxel (Chemo) with or without pembrolizumab (Pembro) for patients (Pts) with metastatic squamous (Sq) non-small cell lung cancer (NSCLC). J Clin Oncol. 2018;36(15_suppl):105.
   Google Scholar
• Mellor AL, Munn DH. IDO expression by dendritic cells: tolerance and tryptophan catabolism. Nat Rev Immunol. 2004;4:762–774.
   PubMed Web of Science ®Google Scholar
• Prendergast GC, Smith C, Thomas S, et al. Indoleamine 2,3-dioxygenase pathways of pathogenic inflammation and immune escape in cancer. Cancer Immunol Immunother. 2014;63:721–735.
   PubMed Web of Science ®Google Scholar
• Godin-Ethier J, Hanafi LA, Piccirillo CA, et al. Indoleamine 2,3-dioxygenase expression in human cancers: clinical and immunologic perspectives. Clin Cancer Res. 2011;17:6985–6991.
   PubMed Web of Science ®Google Scholar
• Schalper KA, Carvajal-Hausdorf D, McLaughlin J, et al. Differential expression and significance of PD-L1, IDO-1, and B7-H4 in human lung cancer. Clin Cancer Res. 2017;23:370–378.
   PubMed Web of Science ®Google Scholar
• Holmgaard RB, Zamarin D, Munn DH, et al. Indoleamine 2,3-dioxygenase is a critical resistance mechanism in antitumor T cell immunotherapy targeting CTLA-4. J Exp Med. 2013;210:1389–1402.
   PubMed Web of Science ®Google Scholar
• Gangadhar TC, Schneider BJ, Bauer TM, et al. Efficacy and safety of epacadostat plus pembrolizumab treatment of NSCLC: preliminary phase I/II results of ECHO-202/KEYNOTE-037. J Clin Oncol. 2017;35(suppl; abstr 9014).
   Google Scholar
• Rudd CE. The reverse stop-signal model for CTLA4 function. Nat Rev Immunol. 2008;8:153–160.
   PubMed Web of Science ®Google Scholar
• Chen L, Flies DB. Molecular mechanisms of T cell co-stimulation and co-inhibition. Nat Rev Immunol. 2013;13:227–242.
   PubMed Web of Science ®Google Scholar
• Parry RV, Chemnitz JM, Frauwirth KA, et al. CTLA-4 and PD-1 receptors inhibit T-cell activation by distinct mechanisms. Mol Cell Biol. 2005;25:9543–9553.
   PubMed Web of Science ®Google Scholar
• Curran MA, Montalvo W, Yagita H, et al. PD-1 and CTLA-4 combination blockade expands infiltrating T cells and reduces regulatory T and myeloid cells within B16 melanoma tumors. Proc Natl Acad Sci U S A. 2010;107:4275–4280.
   PubMed Web of Science ®Google Scholar
• Romano E, Kusio-Kobialka M, Foukas PG, et al. Ipilimumab-dependent cell-mediated cytotoxicity of regulatory T cells ex vivo by nonclassical monocytes in melanoma patients. Proc Natl Acad Sci U S A. 2015;112:6140–6145.
   PubMed Web of Science ®Google Scholar
• 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 Apr 16. [Epub ahead of print].
   Web of Science ®Google Scholar
• Gandhi L, Rodríguez-Abreu D, Gadgeel S, et al. KEYNOTE-189: randomized, double-blind, phase 3 study of pembrolizumab or placebo plus pemetrexed and platinum as first-line therapy for metastatic NSCLC. American Association of Cancer Research (AACR) annual meeting, 2018; Apr 16, Chicago (abstr CT075)
   Google Scholar
• Eggermont AMM, Blank CU, Mandala M, et al. Adjuvant pembrolizumab versus placebo in resected stage III melanoma. N Engl J Med. 2018;378:1789–1801.
   PubMed Web of Science ®Google Scholar
• Ahn M, Yang J, Yu H, et al. Osimertinib combined with durvalumab in EGFR-mutant non-small cell lung cancer: results from the TATTON phase Ib trial. European Lung Cancer Congress (ELCC), 2016; Apr 15, Geneva (abstr 136O)
   Google Scholar
• 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;376:2415–2426.
   PubMed Web of Science ®Google Scholar
• Rizvi H, Sanchez-Vega F, La K, et al. Molecular determinants of response to anti-programmed cell death (PD)-1 and anti-programmed death-ligand 1 (PD-L1) blockade in patients with non-small-cell lung cancer profiled with targeted next-generation sequencing. J Clin Oncol. 2018;36:633–641.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• Tumeh PC, Hellmann MD, Hamid O, et al. Liver metastasis and treatment outcome with anti-PD-1 monoclonal antibody in patients with melanoma and NSCLC. Cancer Immunol Res. 2017;5:417–424.
   PubMed Web of Science ®Google Scholar
• Mamesaya N, Kenmotsu H, Katsumata M, et al. Osimertinib-induced interstitial lung disease after treatment with anti-PD1 antibody. Invest New Drugs. 2017;35:105–107.
   PubMed Web of Science ®Google Scholar