Safety of pembrolizumab in recurrent or advanced gastric cancer expressing PD-L1 refractory to platinum and fluoropyrimidine

References

• International Agency for Research on Cancer. Globocan 2018: stomach. [ cited 2018 Oct 4]. Available from: https://gco.iarc.fr/today/data/factsheets/cancers/7-Stomach-fact-sheet.pdf
   Google Scholar
• Smyth EC, Verheij M, Allum W, et al. Gastric cancer: ESMO clinical practice guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2016;27(suppl 5):v38–49.
   PubMed Web of Science ®Google Scholar
• Japanese Gastric Cancer Association. Japanese gastric cancer treatment guidelines 2014 (version 4). Gastric Cancer. 2017;20:1–19.
   Web of Science ®Google Scholar
• National Comprehensive Cancer Network. Gastric cancer (version 2.2018). [ cited 2018 Aug 15]. Available from: https://www.nccn.org/professionals/physician_gls/pdf/gastric.pdf
   Google Scholar
• 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;366(26):2443–2454.
   PubMed Web of Science ®Google Scholar
• Robert C, Long GV, Brady B, et al. Nivolumab in previously untreated melanoma without BRAF mutation. N Engl J Med. 2015;372(4):320–330.
   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(19):1823–1833.
   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(10027):1540–1550.
   PubMed Web of Science ®Google Scholar
• Motzer RJ, Escudier B, McDermott DF, et al. Nivolumab versus Everolimus in advanced renal-cell carcinoma. N Engl J Med. 2015;373(19):1803–1813.
   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.
   PubMed Web of Science ®Google Scholar
• Ishida Y, Agata Y, Shibahara K, et al. Induced expression of PD-1, a novel member of the immunoglobulin gene superfamily, upon programmed cell death. Embo J. 1992;11(11):3887–3895.
   PubMed Web of Science ®Google Scholar
• Elassaiss-Schaap J, Rossenu S, Lindauer A, et al. Using model-based “learn and confirm” to reveal the pharmacokinetics-pharmacodynamics relationship of pembrolizumab in the KEYNOTE-001 trial. CPT Pharmacometrics Syst Pharmacol. 2017;6(1):21–28.
   PubMedGoogle Scholar
• Ahamadi M, Freshwater T, Prohn M, et al. Model-based characterization of the pharmacokinetics of pembrolizumab: a humanized anti-PD-1 monoclonal antibody in advanced solid tumors. CPT Pharmacometrics Syst Pharmacol. 2017;6(1):49–57.
   PubMedGoogle Scholar
• Chatterjee MS, Elassaiss-Schaap J, Lindauer A, et al. Population pharmacokinetic/pharmacodynamic modeling of tumor size dynamics in pembrolizumab-treated advanced melanoma. CPT Pharmacometrics Syst Pharmacol. 2017;6(1):29–39.
   PubMedGoogle Scholar
• Wang DD, Zhang S, Zhao H, et al. Fixed dosing versus body size-based dosing of monoclonal antibodies in adult clinical trials. J Clin Pharmacol. 2009;49(9):1012–1024.
   PubMed Web of Science ®Google Scholar
• Lala M, Akala O, Chartash E, et al. Pembrolizumab 400 mg Q6W dosing: first clinical outcomes data from keynote-555 cohort B in metastatic melanoma patients. AACR, 2020. CT–042.
   Google Scholar
• Muro K, Chung HC, Shankaran V, et al. Pembrolizumab for patients with PD-L1-positive advanced gastric cancer (KEYNOTE-012): a multicentre, open-label, phase 1b trial. Lancet Oncol. 2016;17(6):717–726.
   PubMed Web of Science ®Google Scholar
• Shitara K, Özgüroğlu M, Bang YJ, et al. Pembrolizumab versus paclitaxel for previously treated, advanced gastric or gastro-oesophageal junction cancer (KEYNOTE-061): a randomised, open-label, controlled, phase 3 trial. Lancet. 2018;392(10142):123–133.
   PubMed Web of Science ®Google Scholar
• Ferris RL, Blumenschein G Jr, Fayette J, et al. Nivolumab for recurrent squamous-cell carcinoma of the head and neck. N Engl J Med. 2016;375:1856–1867.
   PubMed Web of Science ®Google Scholar
• Rittmeyer A, Barlesi F, Waterkamp D, et al. Atezolizumab versus docetaxel in patients with previously treated non-small-cell lung cancer (OAK): a phase 3, open-label, multicentre randomized controlled trial. Lancet. 2017;389:255–265.
   PubMed Web of Science ®Google Scholar
• Wang M, Ma X, Guo L, et al. Safety and efficacy profile of pembrolizumab in solid cancer: pooled reanalysis based on randomized controlled trials. Drug Des Devel Ther. 2017;11:2851–2860.
   PubMed Web of Science ®Google Scholar
• Robert C, Schachter J, Long GV, et al. Pembrolizumab versus ipilimumab in advanced melanoma. N Engl J Med. 2015;372(26):2521–2532.
   PubMed Web of Science ®Google Scholar
• Mok TSK, Wu YL, Dudaba 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;393(10183):1819–1830.
   PubMed Web of Science ®Google Scholar
• Cutsem EV, Amonkar M, Fuchs CS, et al. Impact of pembrolizumab versus paclitaxel on health-related quality of life in patients with advanced gastric or gastroesophageal junction cancer that has progressed after first-line chemotherapy (KEYNOTE-061). Ann Oncol. 2019;30(suppl_5):abstr 4653.
   Google Scholar
• Chatterjee M, Turner DC, Felip E, et al. Systematic evaluation of pembrolizumab dosing in patients with advanced non-small-cell lung cancer. Ann Oncol. 2016;27:1291–1298.
   PubMedGoogle Scholar
• Bando H, Doi T, Muro K, et al. A multicenter phase II study of TAS-102 monotherapy in patients with pre-treated advanced gastric cancer (EPOC1201). Eur J Cancer. 2016;62:46–53.
   PubMed Web of Science ®Google Scholar
• Shitara K, Doi T, Dvorkin M, et al. Trifluridine/tipiracil versus placebo in patients with heavily pretreated metastatic gastric cancer (TAGS): a randomised, double-blind, placebocontrolled, phase 3 trial. Lancet Oncol. 2018;19:1437–1448.
   PubMed Web of Science ®Google Scholar
• Shitara K, Bang TJ, Iwasa S, et al. Trastuzumab deruxtecan in previously treated HER2-positive gastric cancer. N Engl J Med. 2020;382:2419–2430.
   PubMed Web of Science ®Google Scholar
• Ishii T, Kawazoe A, Sasaki A, et al. Clinical and molecular factors for selection of nivolumab or irinotecan as third-line treatment for advanced gastric cancer. Ther Adv Med Oncol. Ther Adv Med Oncol. 2020;12:1–12.
   Web of Science ®Google Scholar
• Shitara K, Custem EV, Bang YJ, et al. Pembrolizumab or pembrolizumab plus chemotherapy versus chemotherapy for first-line, advanced gastric cancer (KEYNOTE-062): a randomized, controlled phase 3 study. JAMA Oncol. [in press].
   Google Scholar
• Ozao-Choy J, Ma G, Kao J, et al. The novel role of tyrosine kinase inhibitor in the reversal of immune suppression and modulation of tumor microenvironment for immune-based cancer therapies. Cancer Res. 2009;69:2514–2522.
   PubMed Web of Science ®Google Scholar
• Fondevila F, Méndez-Blanco C, Fernández-Palanca P, et al. Anti-tumoral activity of single and combined regorafenib treatments in preclinical models of liver and gastrointestinal cancers. Exp Mol Med. 2019;51(9):1–15.
   PubMedGoogle Scholar
• Fukuoka S, Hara H, Takahashi N, et al. Regorafenib plus nivolumab in patients with advanced gastric (GC) or colorectal cancer (CRC): an open-label, dose-finding, and dose-expansion phase 1b trial (REGONIVO, EPOC1603). J Clin Oncol. 2020;38:2053–2061. [Epub ahead of print].
   PubMed Web of Science ®Google Scholar
• Kawazoe A, Fukuoka S, Nakamura Y, et al. Lenvatinib plus pembrolizumab in patients with advanced gastric cancer in the first-line or second-line setting (EPOC1706): an open-label, single-arm, phase 2 trial. Lancet Oncol. 2020. [Epub ahead of print]. DOI:10.1016/S1470-2045(20)30271-0
   PubMedGoogle Scholar