Envafolimab – first PD-1/PD-L1 antibody to be administered by subcutaneous injection for microsatellite instability-high or deficient mismatch repair advanced solid tumors

References

• Chong S, Mezzadra R, Schumacher TN. Regulation and Function of the PD-L1 checkpoint. Immunity. 2018;48(3):434–452.
   PubMed Web of Science ®Google Scholar
• Li J, Deng Y, Zhang W, et al. Subcutaneous envafolimab monotherapy in patients with advanced defective mismatch repair/microsatellite instability high solid tumors. J Hematol Oncol. 2021;14(1):95.
   PubMed Web of Science ®Google Scholar
• Memmott RM, Wolfe AR, Carbone DP, et al. Predictors of response, progression free survival, and overall survival in lung cancer patients treated with immune checkpoint inhibitors. J Thorac Oncol. 2021;16(7):1086–1098.
   PubMed Web of Science ®Google Scholar
• Rizzo A, Ricci AD. PD-L1, TMB, and other potential predictors of response to immunotherapy for hepatocellular carcinoma: how can they assist drug clinical trials? Expert Opin Investig Drugs. 2022;31(4):415–423.
   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(6349):409–413.
   PubMed Web of Science ®Google Scholar
• Hause RJ, Pritchard CC, Shendure J, et al. Classification and characterization of microsatellite instability across 18 cancer types. Nat Med. 2016;22(11):1342–1350.
   PubMed Web of Science ®Google Scholar
• Bonneville R, Krook MA, Kautto EA, et al. Landscape of microsatellite instability across 39 cancer types. JCO Precis Oncol. 2017;2017:PO.17.00073 .
   PubMedGoogle Scholar
• Sheng Y, Wang K, Lu Q, et al. Nanobody-horseradish peroxidase fusion protein as an ultrasensitive probe to detect antibodies against newcastle disease virus in the immunoassay. J Nanobiotechnology. 2019;17(1):35.
   PubMedGoogle Scholar
• Roshan R, Naderi S, Behdani M, et al. Isolation and characterization of nanobodies against epithelial cell adhesion molecule as novel theranostic agents for cancer therapy. Mol Immunol. 2021;129:70–77.
   PubMed Web of Science ®Google Scholar
• Lee JY, Lee HT, Shin W, et al. Structural basis of checkpoint blockade by monoclonal antibodies in cancer immunotherapy. Nat Commun. 2016;7:13354.
   PubMed Web of Science ®Google Scholar
• Zhang F, Wei H, Wang X, et al. Structural basis of a novel PD-L1 nanobody for immune checkpoint blockade. Cell Discov. 2017;3:17004.
   PubMed Web of Science ®Google Scholar
• Yamazaki T, Akiba H, Iwai H, et al. Expression of programmed death 1 ligands by murine T cells and APC. J Immunol. 2002;169(10):5538–5545.
   PubMed Web of Science ®Google Scholar
• Herbst RS, Soria JC, Kowanetz M, et al. Predictive correlates of response to the anti-PD-L1 antibody MPDL3280A in cancer patients. Nature. 2014;515(7528):563–567.
   PubMed Web of Science ®Google Scholar
• Papadopoulos KP, Harb W, Peer CJ, et al. First-in-human phase I study of envafolimab, a novel subcutaneous single-domain Anti-PD-L1 antibody, in patients with advanced solid tumors. Oncologist. 2021;26(9): e1514–e1525 .
   PubMed Web of Science ®Google Scholar
• Andre T, Shiu KK, Kim TW, et al. Pembrolizumab in microsatellite-Instability-High advanced colorectal cancer. N Engl J Med. 2020;383(23):2207–2218.
   PubMed Web of Science ®Google Scholar
• Xiao Y, Yu S, Zhu B, et al. RGMb is a novel binding partner for PD-L2 and its engagement with PD-L2 promotes respiratory tolerance. J Exp Med. 2014;211(5):943–959.
   PubMed Web of Science ®Google Scholar
• Yu S, Leung KM, Kim HY, et al. Blockade of RGMb inhibits allergen-induced airways disease. J Allergy Clin Immunol. 2019;144(1): 94–108.e11.
   PubMed Web of Science ®Google Scholar
• Le DT, Kim TW, Van Cutsem E, et al. Phase II open-label study of pembrolizumab in treatment-refractory, microsatellite instability-high/mismatch repair-deficient metastatic colorectal cancer: KEYNOTE-164. J Clin Oncol. 2020;38(1): 11–19.
   PubMed Web of Science ®Google Scholar
• Chao J, Fuchs CS, Shitara K, et al. Wainberg, assessment of pembrolizumab therapy for the treatment of microsatellite instability-high gastric or gastroesophageal junction cancer among patients in the KEYNOTE-059, KEYNOTE-061, and KEYNOTE-062 clinical trials. JAMA Oncol. 2021;7(6) :895–902.
   PubMed Web of Science ®Google Scholar
• Marabelle A, Le DT, Ascierto PA, et al. Efficacy of pembrolizumab in patients with Noncolorectal high microsatellite instability/mismatch repair-deficient cancer: results from the phase II KEYNOTE-158 study. J Clin Oncol. 2020;38:1–10.
   PubMed Web of Science ®Google Scholar
• O’Malley DM, Bariani GM, Cassier PA, et al. Pembrolizumab in patients with microsatellite instability-high advanced endometrial cancer: results from the KEYNOTE-158 study. J Clin Oncol. 2022;40:752–761.
   PubMed Web of Science ®Google Scholar
• Bellone S, Roque DM, Siegel ER, et al. A phase 2 evaluation of pembrolizumab for recurrent Lynch-like versus sporadic endometrial cancers with microsatellite instability. Cancer. 2022;128:1206–1218.
   PubMed Web of Science ®Google Scholar
• Raj N, Zheng Y, Kelly V, et al. PD-1 blockade in advanced adrenocortical Carcinoma. J Clin Oncol. 2020;38:71–80.
   PubMed Web of Science ®Google Scholar
• Overman MJ, McDermott R, Leach JL, et al. Nivolumab in patients with metastatic DNA mismatch repair-deficient or microsatellite instability-high colorectal cancer (CheckMate 142): an open-label, multicentre, phase 2 study. Lancet Oncol. 2017;18:1182–1191.
   PubMed Web of Science ®Google Scholar
• Ott PA, Le DT, Kim JW, et al. Nivolumab (NIVO) in patients (pts) with advanced (adv) chemotherapy-refractory (CT-Rx) esophagogastric (EG) cancer according to microsatellite instability (MSI) status: checkmate 032. Ann Oncol. 2017;28:v229–v230.
   Web of Science ®Google Scholar
• Azad NS, Gray RJ, Overman MJ, et al. Nivolumab is effective in mismatch repair-deficient noncolorectal cancers: results from Arm Z1D-A subprotocol of the NCI-MATCH (EAY131) study. J Clin Oncol. 2020;38:214–222.
   PubMed Web of Science ®Google Scholar
• Segal NH, Wainberg ZA, Overman MJ, et al. Safety and clinical activity of durvalumab monotherapy in patients with microsatellite instability–high (MSI-H) tumors. J Clin Oncol. 2019;37(4_suppl): 670–670 .
   Web of Science ®Google Scholar
• Antill Y, Kok PS, Robledo K, et al. Clinical activity of durvalumab for patients with advanced mismatch repair-deficient and repair-proficient endometrial cancer. A nonrandomized phase 2 clinical trial. J Immunother Cancer. 2021;9(6): e002255.
   PubMed Web of Science ®Google Scholar
• Oaknin A, Gilbert L, Tinker AV, et al. Safety and antitumor activity of dostarlimab in patients with advanced or recurrent DNA mismatch repair deficient/microsatellite instability-high (dMMR/MSI-H) or proficient/stable (MMRp/MSS) endometrial cancer: interim results from GARNET-a phase I, single-arm study. J Immunother Cancer. 2022;10(1): e003777.
   PubMed Web of Science ®Google Scholar
• Andre T, Berton D, Curigliano G, et al. Safety and efficacy of anti–PD-1 antibody dostarlimab in patients (pts) with mismatch repair-deficient (dMMR) solid cancers: results from GARNET study. J Clin Oncol. 2021;39(3_suppl): 9–9 .
   Web of Science ®Google Scholar
• Konstantinopoulos PA, Luo W, Liu JF, et al. Phase II study of avelumab in patients with mismatch repair deficient and mismatch repair proficient recurrent/persistent endometrial cancer. J Clin Oncol. 2019;37:2786–2794.
   PubMed Web of Science ®Google Scholar
• Kim JH, Kim SY, Baek JY, et al. A phase II study of avelumab monotherapy in patients with mismatch repair-deficient/microsatellite instability-high or pole-mutated metastatic or unresectable colorectal cancer. Cancer Res Treat. 2020;52:1135–1144.
   PubMed Web of Science ®Google Scholar
• Felip E, Moreno V, Morgensztern D, et al. First-in-human, open-label, phase 1/2 study of the monoclonal antibody programmed cell death protein-1 (PD-1) inhibitor cetrelimab (JNJ-63723283) in patients with advanced cancers. Cancer Chemother Pharmacol. 2022;89:499–514.
   PubMed Web of Science ®Google Scholar
• Chen J, Quan M, Chen Z, et al. Camrelizumab in advanced or metastatic solid tumour patients with DNA mismatch repair deficient or microsatellite instability high: an open-label prospective pivotal trial. J Cancer Res Clin Oncol. 2020;146:2651–2657.
   PubMed Web of Science ®Google Scholar
• Huang J, Song Y, Luo S, et al. Efficacy of HX008 in high microsatellite instability/mismatch repair–deficient (MSI-H/dMMR) solid tumors: results from a multicenter phase II open-label study. J Clin Oncol. 2021.
   Google Scholar
• Qin S, Li J, Zhong H, et al. Efficacy and safety of HLX10, a novel anti-PD-1 antibody, in patients with previously treated unresectable or metastatic microsatellite instability-high or mismatch repair-deficient solid tumors: a single-arm, multicenter, phase 2 study. J Clin Oncol. 2021;39(15_suppl):2566–2566.
   Web of Science ®Google Scholar
• Li J, Xu Y, Zang A, et al. A phase 2 study of tislelizumab monotherapy in patients with previously treated, locally advanced unresectable or metastatic microsatellite instability-high/mismatch repair deficient solid tumors. J Clin Oncol. 2021;39(15): 2569-2569.
   Web of Science ®Google Scholar