Review Article

多发性骨髓瘤单克隆抗体的临床和药理学特征以及检查站封锁疗法

卷 26, 期 32, 2019

页: [5968 - 5981] 页: 14

弟呕挨: 10.2174/0929867325666180514114806

价格: $65

摘要

背景:由于引入了许多新药,包括免疫调节剂,蛋白酶体抑制剂和最近的单克隆抗体,在过去的几十年中,多发性骨髓瘤患者的存活率已大大提高。 方法:我们分析了针对多发性骨髓瘤中基于单克隆抗体的疗法的临床和药理学方面的最新文献,包括针对浆细胞抗原的单克隆抗体以及针对免疫抑制分子的检查点阻断疗法(用作单一药物)或联合疗法。 结果:抗CD38单克隆抗体(包括daratumumab,isatuximab和MOR202)在复发和/或难治性多发性骨髓瘤患者中显示出出色的结果。在硼替佐米-地塞米松或来那度胺地塞米松中添加daratumumab可以显着改善该患者人群的预后。抗SLAMF7分子依洛珠单抗联合来那度胺-地塞米松显示优于单独的来那度胺-地塞米松,而没有增加有意义的毒性。结合免疫调节剂进行的检查点封锁疗法在超过50%的治疗患者中产生了客观反应。但是,这种组合也与毒性增加有关,目前正在进行全面的安全性评估。 结论:单克隆抗体正在改变多发性骨髓瘤的治疗标准,正在进行的试验将帮助医生优化使用,以进一步改善患者的治疗效果。

关键词: 多发性骨髓瘤(MM),单克隆抗体(mAbs),检查点封锁疗法(CBT),SLAMF7,CD38,PD-1,PD-L1。

[1]
Palumbo, A.; Anderson, K. Multiple myeloma. N. Engl. J. Med., 2011, 364(11), 1046-1060.
[http://dx.doi.org/10.1056/NEJMra1011442] [PMID: 21410373]
[2]
Pozzi, S.; Marcheselli, L.; Bari, A.; Liardo, E.V.; Marcheselli, R.; Luminari, S.; Quaresima, M.; Cirilli, C.; Ferri, P.; Federico, M.; Sacchi, S. Survival of multiple myeloma patients in the era of novel therapies confirms the improvement in patients younger than 75 years: a population-based analysis. Br. J. Haematol., 2013, 163(1), 40-46.
[http://dx.doi.org/10.1111/bjh.12465] [PMID: 23889344]
[3]
Costa, L.J.; Brill, I.K.; Omel, J.; Godby, K.; Kumar, S.K.; Brown, E.E. Recent trends in multiple myeloma incidence and survival by age, race, and ethnicity in the United States. Blood Adv., 2017, 1(4), 282-287.
[http://dx.doi.org/10.1182/bloodadvances.2016002493] [PMID: 29296944]
[4]
D’Agostino, M.; Boccadoro, M.; Smith, E.L. Novel Immunotherapies for Multiple Myeloma. Curr. Hematol. Malig. Rep., 2017, 12(4), 344-357.
[http://dx.doi.org/10.1007/s11899-017-0397-7] [PMID: 28819882]
[5]
Romano, A.; Conticello, C.; Cavalli, M.; Vetro, C.; La Fauci, A.; Parrinello, N.L.; Di Raimondo, F. Immunological dysregulation in multiple myeloma microenvironment. BioMed Res. Int., 2014, 2014198539
[http://dx.doi.org/10.1155/2014/198539] [PMID: 25013764]
[6]
Gay, F.; D’Agostino, M.; Giaccone, L.; Genuardi, M.; Festuccia, M.; Boccadoro, M.; Bruno, B. Immuno-oncologic approaches: CAR-T cells and checkpoint inhibitors. Clin. Lymphoma Myeloma Leuk., 2017, 17(8), 471-478.
[http://dx.doi.org/10.1016/j.clml.2017.06.014] [PMID: 28689001]
[7]
van de Donk, N.W.C.J.; Moreau, P.; Plesner, T.; Palumbo, A.; Gay, F.; Laubach, J.P.; Malavasi, F.; Avet-Loiseau, H.; Mateos, M.V.; Sonneveld, P.; Lokhorst, H.M.; Richardson, P.G. Clinical efficacy and management of monoclonal antibodies targeting CD38 and SLAMF7 in multiple myeloma. Blood, 2016, 127(6), 681-695.
[http://dx.doi.org/10.1182/blood-2015-10-646810] [PMID: 26631114]
[8]
Dunkelberger, J.R.; Song, W.C. Complement and its role in innate and adaptive immune responses. Cell Res., 2010, 20(1), 34-50.
[http://dx.doi.org/10.1038/cr.2009.139] [PMID: 20010915]
[9]
Dong, J.Q.; Salinger, D.H.; Endres, C.J.; Gibbs, J.P.; Hsu, C.P.; Stouch, B.J.; Hurh, E.; Gibbs, M.A. Quantitative prediction of human pharmacokinetics for monoclonal antibodies: retrospective analysis of monkey as a single species for first-in-human prediction. Clin. Pharmacokinet., 2011, 50(2), 131-142.
[http://dx.doi.org/10.2165/11537430-000000000-00000] [PMID: 21241072]
[10]
Mould, D.R.; Green, B. Pharmacokinetics and pharmacodynamics of monoclonal antibodies: concepts and lessons for drug development. BioDrugs, 2010, 24(1), 23-39.
[http://dx.doi.org/10.2165/11530560-000000000-00000] [PMID: 20055530]
[11]
Vugmeyster, Y.; Xu, X.; Theil, F.P.; Khawli, L.A.; Leach, M.W. Pharmacokinetics and toxicology of therapeutic proteins: Advances and challenges. World J. Biol. Chem., 2012, 3(4), 73-92.
[http://dx.doi.org/10.4331/wjbc.v3.i4.73] [PMID: 22558487]
[12]
Deaglio, S.; Mehta, K.; Malavasi, F. Human CD38: a (r)evolutionary story of enzymes and receptors. Leuk. Res., 2001, 25(1), 1-12.
[http://dx.doi.org/10.1016/s0145-2126(00)00093-x] [PMID: 11137554]
[13]
Lin, P.; Owens, R.; Tricot, G.; Wilson, C.S. Flow Cytometric Immunophenotypic Analysis of 306 Cases of Multiple Myeloma. Am. J. Clin. Pathol., 2004, 121(4), 482-488.
[http://dx.doi.org/ 10.1309/74R4-TB90-BUWH-27JX] [PMID: 15080299]
[14]
Dianzani, U.; Funaro, A.; DiFranco, D.; Garbarino, G.; Bragardo, M.; Redoglia, V.; Buonfiglio, D.; De Monte, L.B.; Pileri, A.; Malavasi, F. Interaction between endothelium and CD4+CD45RA+ lymphocytes. Role of the human CD38 molecule. J. Immunol., 1994, 153(3), 952-959.
[PMID: 7913116]
[15]
An, G.; Jiang, H.; Acharya, C. SAR 650984, a Therapeutic Anti-CD38 monoclonal antibody, blocks CD38-CD31 interaction in multiple myeloma. Blood, 2014, 124(21), 4729.
[http://dx.doi.org/ https://doi.org/10.1182/blood.V124.21.4729.4729]
[16]
van de Donk, N.W.C.J.; Janmaat, M.L.; Mutis, T.; Lammerts van Bueren, J.J.; Ahmadi, T.; Sasser, A.K.; Lokhorst, H.M.; Parren, P.W. Monoclonal antibodies targeting CD38 in hematological malignancies and beyond. Immunol. Rev., 2016, 270(1), 95-112.
[http://dx.doi.org/10.1111/imr.12389] [PMID: 26864107]
[17]
Lammerts van Bueren, J.; Jakobs, D.; Kaldenhoven, N. Direct in vitro comparison of daratumumab with surrogate analogs of CD38 Antibodies MOR03087, SAR650984 and Ab79. Blood, 2014, 124(21), 3474.
[http://dx.doi.org/ 10.1182/blood.V124.21.3474.3474]
[18]
Mattes, M.J.; Michel, R.B.; Goldenberg, D.M.; Sharkey, R.M. Induction of apoptosis by cross-linking antibodies bound to human b-lymphoma cells: expression of annexin v binding sites on the antibody cap. Cancer Biother. Radiopharm., 2009, 24(2), 185-193.
[http://dx.doi.org/10.1089/cbr.2008.0567] [PMID: 19409040]
[19]
Oostendorp, M.; Lammerts van Bueren, J.J.; Doshi, P.; Khan, I.; Ahmadi, T.; Parren, P.W.; van Solinge, W.W.; De Vooght, K.M. When blood transfusion medicine becomes complicated due to interference by monoclonal antibody therapy. Transfusion, 2015, 55(6 Pt 2), 1555-1562.
[http://dx.doi.org/ 10.1111/trf.13150] [PMID: 25988285]
[20]
van de Donk, N.W.C.J.; Richardson, P.G.; Malavasi, F. CD38 antibodies in multiple myeloma: back to the future. Blood, 2018, 131(1), 13-29.
[http://dx.doi.org/ 10.1182/blood-2017-06-740944] [PMID: 29118010]
[21]
Kotlikoff, M.I.; Kannan, M.S.; Solway, J.; Deng, K.Y.; Deshpande, D.A.; Dowell, M.; Feldman, M.; Green, K.S.; Ji, G.; Johnston, R.; Lakser, O.; Lee, J.; Lund, F.E.; Milla, C.; Mitchell, R.W.; Nakai, J.; Rishniw, M.; Walseth, T.F.; White, T.A.; Wilson, J.; Xin, H.B.; Woodruff, P.G. Methodologic advancements in the study of airway smooth muscle. J. Allergy Clin. Immunol., 2004, 114(2 Suppl.), S18-S31.
[http://dx.doi.org/ 10.1016/j.jaci.2004.04.040] [PMID: 15309016]
[22]
Engelhardt, M.; Berger, D.P.; Mertelsmann, R.; Duyster, J., Eds.; The Blue Book Chemotherapy Manual Hematology and Oncology; Springer-Verlag: Berlin, 2016.
[23]
Scheid, C.; Munder, M.; Salwender, H.; Engelhardt, M. [Infusion of daratumumab in combination therapies - practical information for the outpatient area]. Dtsch. Med. Wochenschr., 2018, 143(16), 1201-1206.
[http://dx.doi.org/10.1055/a-0595-5397] [PMID: 29874684]
[24]
Köhler, M.; Greil, C.; Hudecek, M.; Lonial, S.; Raje, N.; Wäsch, R.; Engelhardt, M. Current developments in immunotherapy in the treatment of multiple myeloma. Cancer, 2018, 124(10), 2075-2085.
[http://dx.doi.org/10.1002/cncr.31243] [PMID: 29409124]
[25]
Chari, A.; Mark, T.M.; Krishnan, A. Use of montelukast to reduce infusion reactions in an early access treatment protocol of daratumumab in United States patients with relapsed or refractory multiple myeloma. Blood, 2016, 128(22), 2142.
[http://dx.doi.org/ 10.1182/blood.V128.22.2142.2142]
[26]
de Weers, M.; Tai, Y-T.; van der Veer, M.S.; Bakker, J.M.; Vink, T.; Jacobs, D.C.; Oomen, L.A.; Peipp, M.; Valerius, T.; Slootstra, J.W.; Mutis, T.; Bleeker, W.K.; Anderson, K.C.; Lokhorst, H.M.; van de Winkel, J.G.; Parren, P.W. Daratumumab, a novel therapeutic human CD38 monoclonal antibody, induces killing of multiple myeloma and other hematological tumors. J. Immunol., 2011, 186(3), 1840-1848.
[http://dx.doi.org/10.4049/jimmunol.1003032] [PMID: 21187443]
[27]
Clemens, P.L.; Yan, X.; Lokhorst, H.M.; Lonial, S.; Losic, N.; Khan, I.; Jansson, R.; Ahmadi, T.; Lantz, K.; Zhou, H.; Puchalski, T.; Xu, X.S. Pharmacokinetics of Daratumumab following intravenous infusion in relapsed or refractory multiple myeloma after prior proteasome inhibitor and immunomodulatory drug treatment. Clin. Pharmacokinet., 2017, 56(8), 915-924.
[http://dx.doi.org/10.1007/s40262-016-0477-1] [PMID: 27896689]
[28]
Lokhorst, H.M.; Plesner, T.; Laubach, J.P. Targeting CD38 with daratumumab monotherapy in multiple myeloma. N. Engl. J. Med., 2015, 373, 1207-1219.
[http://dx.doi.org/10.1056/NEJMoa1506348]
[29]
Zirkelbach, J.F.; Habtermariam, B.; Ma, L. 761036Orig1s000. Clinical Pharmacology and Biopharmaceutics Review(s). 2017. Accessed on: Dec. 14, 2017). https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/761036Orig1s000ClinPharmR.pdf
[30]
Lonial, S.; Weiss, B.M.; Usmani, S.Z.; Singhal, S.; Chari, A.; Belch, N.J.B.; Krishnan, A.Y.; Vescio, R.A.; Mateos, M-V.; Mazumder, A.; Orlowski, R.Z.; Sutherland, H.J.; Blade, J.; Scott, E.C.; Feng, H.; Khan, I.; Uhlar, C.M.; Ahmadi, T.; Voorhees, P.M. Phase II study of daratumumab (DARA) monotherapy in patients with ≥ 3 lines of prior therapy or double refractory multiple myeloma (MM): 54767414MMY2002 (Sirius). J. Clin. Oncol., 2015, 33Abstract LBA8512.
[31]
Xu, X.; Yan, X.; Puchalski, T.; Lonial, S.; Lokhorst, H.M.; Voorhees, P.M.; Plesner, T.; Liu, K.; Khan, I.; Jansson, R.; Ahmadi, T.; Ruixo, J.P.; Zhou, H.; Clemens, P.L. Clinical implications of complex pharmacokinetics for daratumumab dose regimen in patients with relapsed/refractory multiple myeloma. Clin. Pharmacol. Ther., 2017, 101(6), 721-724.
[http://dx.doi.org/10.1002/cpt.577] [PMID: 27859027]
[32]
Palumbo, A.; Chanan-Khan, A.; Weisel, K. Daratumumab, bortezomib, and dexamethasone for multiple myeloma. N. Engl. J. Med., 2016, 375, 754-766.
[http://dx.doi.org/10.1056/NEJMoa1606038]
[33]
Dimopoulos, M.A.; Oriol, A.; Nahi, H.; San-Miguel, J.; Bahlis, N.J.; Usmani, S.Z.; Rabin, N.; Orlowski, R.Z.; Komarnicki, M.; Suzuki, K.; Plesner, T.; Yoon, S-S.; Yehuda, D.B.; Richardson, P.G.; Goldschmidt, H.; Reece, D.; Lisby, S.; Khokhar, N.Z.; O’Rourke, L.; Chiu, C.; Qin, X.; Guckert, M.; Ahmadi, T.; Moreau, P. Daratumumab, Lenalidomide, and Dexamethasone for Multiple Myeloma. N. Engl. J. Med., 2016, 375, 1319-1331.
[http://dx.doi.org/10.1056/NEJMoa1607751]
[34]
Plesner, T.; Arkenau, H-T.; Gimsing, P.; Krejcik, J.; Lemech, C.; Minnema, M.C.; Lassen, U.; Laubach, J.P.; Palumbo, A.; Lisby, S.; Basse, L.; Wang, J.; Sasser, A.K.; Guckert, M.E.; de Boer, C.; Khokhar, N.Z.; Yeh, H.; Clemens, P.L.; Ahmadi, T.; Lokhorst, H.M.; Richardson, P.G. Phase 1/2 study of daratumumab, lenalidomide, and dexamethasone for relapsed multiple myeloma. Blood, 2016, 128(14), 1821-1828.
[http://dx.doi.org/10.1182/blood-2016-07-726729] [PMID: 27531679]
[35]
Weisel, K.C.; San Miguel, J.; Cook, G.; Leiba, M.; Suzuki, K.; Kumar, S.; Cavo, M.; Avet-Loiseau, H.; Quach, H.; Hungria, V.; Lentzsch, S.; Hajek, R.; Sonneveld, P.; Wu, K.; Qin, X.; Chiu, C.; Soong, D.; Qi, M.; Schecter, J.M.; Dimopoulos, M.A. Efficacy of daratumumab in combination with lenalidomide plus dexamethasone (DRd) or bortezomib plus dexamethasone (DVd) in relapsed or refractory multiple myeloma (RRMM) based on cytogenetic risk status. J. Clin. Oncol., 2017, 35(15), 8006.
[http://dx.doi.org/10.1200/JCO.2017.35.15_suppl.8006]
[36]
Chari, A.; Suvannasankha, A.; Fay, J.W.; Arnulf, B.; Kaufman, J.L.; Ifthikharuddin, J.J.; Weiss, B.M.; Krishnan, A.; Lentzsch, S.; Comenzo, R.; Wang, J.; Nottage, K.; Chiu, C.; Khokhar, N.Z.; Ahmadi, T.; Lonial, S. Daratumumab plus pomalidomide and dexamethasone in relapsed and/or refractory multiple myeloma. Blood, 2017, 130(8), 974-981.
[http://dx.doi.org/10.1182/blood-2017-05-785246] [PMID: 28637662]
[37]
San Miguel, J.; Weisel, K.; Moreau, P.; Lacy, M.; Song, K.; Delforge, M.; Karlin, L.; Goldschmidt, H.; Banos, A.; Oriol, A.; Alegre, A.; Chen, C.; Cavo, M.; Garderet, L.; Ivanova, V.; Martinez-Lopez, J.; Belch, A.; Palumbo, A.; Schey, S.; Sonneveld, P.; Yu, X.; Sternas, L.; Jacques, C.; Zaki, M.; Dimopoulos, M. Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial. Lancet Oncol., 2013, 14(11), 1055-1066.
[http://dx.doi.org/10.1016/S1470-2045(13)70380-2] [PMID: 24007748]
[38]
DARZALEX®. Daratumumab. Product Information. JANSSEN-CILAG Pty Ltd. Macquarie Park NSW 2113-- Auckland (AU--NZN); 2017. Available at:. http://www.janssen.com/australia/sites/www_janssen_com_australia/files/prod_files/live/darzalex_pi.pdf [Accessed: 2017 Dec 15]
[39]
Mateos, M-V.; Dimopoulos, M.A.; Cavo, M.; Suzuki, K.; Jakubowiak, A.; Knop, S.; Doyen, C.; Lucio, P.; Nagy, Z.; Kaplan, P.; Pour, L.; Cook, M.; Grosicki, S.; Crepaldi, A.; Liberati, A.M.; Campbell, P.; Shelekhova, T.; Yoon, S-S.; Iosava, G.; Fujisaki, T.; Garg, M.; Chiu, C.; Wang, J.; Carson, R.; Crist, W.; Deraedt, W.; Nguyen, H.; Qi, M.; San-Miguel, J. Daratumumab plus bortezomib, melphalan, and prednisone for untreated myeloma. N. Engl. J. Med., 2018, 378, 518-528.
[http://dx.doi.org/10.1056/NEJMoa1714678]
[40]
Chari, A.; Nahi, H.; Mateos, M-V. Subcutaneous delivery of daratumumab in patients (pts) with relapsed or refractory multiple myeloma (RRMM): PAVO, an open-label, multicenter, dose escalation phase 1b study. Blood, 2017, 130, 838.
[41]
Usmani, S.Z.; Nahi, H.; Mateos, M-V.; Lokhorst, H.M.; Chari, A.; Kaufman, J.L.; Moreau, P.; Oriol, A.; Plesner, T.; Benboubker, L.; Hellemans, P.; Masterson, T.; Clemens, P.L.; Ahmadi, T.; Liu, K.; San-Miguel, J. Open-label, multicenter, dose escalation phase 1b study to assess the subcutaneous delivery of daratumumab in patients (pts) with relapsed or refractory multiple myeloma (PAVO). Blood, 2016, 128(22), 1149.
[http://dx.doi.org/10.1182/blood.V128.22.1149.1149]
[42]
Deckert, J.; Wetzel, M-C.; Bartle, L.M.; Skaletskaya, A.; Goldmacher, V.S.; Vallée, F.; Zhou-Liu, Q.; Ferrari, P.; Pouzieux, S.; Lahoute, C.; Dumontet, C.; Plesa, A.; Chiron, M.; Lejeune, P.; Chittenden, T.; Park, P.U.; Blanc, V. SAR650984, a novel humanized CD38-targeting antibody, demonstrates potent antitumor activity in models of multiple myeloma and other CD38+ hematologic malignancies. Clin. Cancer Res., 2014, 20(17), 4574-4583.
[http://dx.doi.org/10.1158/1078-0432.CCR-14-0695] [PMID: 24987056]
[43]
Martin, T.; Richter, J.; Vij, R.; Cole, C.; Atanackovic, D.; Zonder, J.; Kaufman, J.L.; Bensinger, W.; Dimopoulos, M.A.; Miguel, J.S.; Zimmerman, T.; Lendvai, N.; Hari, P.; Ocio, E.M.; Gasparetto, C.; Kumar, S.; Hsu, K.; Charpentier, E.; Strickland, S.A.; Mikhael, J. A dose finding phase ii trial of isatuximab (SAR650984, Anti-CD38 mAb) as a single agent in relapsed/refractory multiple myeloma. Blood, 2015, 126(23), 509.
[http://dx.doi.org/https://doi.org/10.1182/blood.V126.23.509.509]
[44]
Martin, T.; Strickland, S.; Glenn, M.; Mikhael, J.; Charpentier, E.; Hsu, K. Phase I trial of SAR650984, a CD38 monoclonal antibody, in relapsed or refractory multiple myeloma.Am. Soc. Clin. Oncol; [ASCO] Annu. Meet. Chicago: ASCO. , 2014, p. Poster Abstract 8532.
[45]
D’Agostino, M.; Salvini, M.; Palumbo, A.; Larocca, A.; Gay, F. Novel investigational drugs active as single agents in multiple myeloma. Expert Opin. Investig. Drugs, 2017, 26(6), 699-711.
[http://dx.doi.org/10.1080/13543784.2017.1324571] [PMID: 28448171]
[46]
Martin, T.; Baz, R.; Benson, D.M.; Lendvai, N.; Wolf, J.; Munster, P.; Lesokhin, A.M.; Wack, C.; Charpentier, E.; Campana, F.; Vij, R. A phase 1b study of isatuximab plus lenalidomide and dexamethasone for relapsed/refractory multiple myeloma. Blood, 2017, 129(25), 3294-3303.
[http://dx.doi.org/10.1182/blood-2016-09-740787] [PMID: 28483761]
[47]
Mikhael, J.; Richardson, P.G.; Usmani, S.Z.; Raje, N.; Bensinger, W; Kanagavel, D.; Gao, L.; Ziti-ljajic, S.; Anderson, K. A phase Ib study of isatuximab in combination with pomalidomide (Pom) and dexamethasone (Dex) in relapsed/refractory multiple myeloma (RRMM). Am. Soc. Clin. Oncol., 2017.Abstract 144708.
[48]
Tawara, T.; Hasegawa, K.; Sugiura, Y.; Harada, K.; Miura, T.; Hayashi, S.; Tahara, T.; Ishikawa, M.; Yoshida, H.; Kubo, K.; Ishida, I.; Kataoka, S. Complement activation plays a key role in antibody-induced infusion toxicity in monkeys and rats. J. Immunol., 2008, 180(4), 2294-2298.
[http://dx.doi.org/10.4049/jimmunol.180.4.2294] [PMID: 18250438]
[49]
Raab, M.; Chatterjee, M.; Goldschmidt, H.; Agis, H.; Blau, I.W.; Einsele, H.; Engelhardt, M.M.; Ferstl, B.; Gramatzki, M.; Röllig, C.; Weisel, K.C.; Jarutat, T.; Weinelt, D.; Winderlich, M.; Boxhammer, R.; Peschel, C. MOR202 with low-dose dexamethasone (Dex) and in combination with pomalidomide/dex and lenalidomide/dex in relapsed or refractory multiple myeloma (RRMM): interim analysis of a phase I/IIa dose-escalation study. J. Clin. Oncol., 2017, 35(Suppl. 15), 8024.
[http://dx.doi.org/10.1200/JCO.2017.35.15_suppl.8024]
[50]
Raab, M.S.; Goldschmidt, H.; Agis, H.; Agis, H.; Blau, I.; Einsele, H.; Engelhardt, M.M.; Ferstl, B.; Gramatzki, M.; Röllig, C.; Weisel, K. Kloepfer, p.; Weinelt, D.; Härtle, S.; Peschel, C. A phase I/IIa study of the human anti-CD38 antibody MOR202 (MOR03087) in relapsed or refractory multiple myeloma (rrMM). J. Clin. Oncol., 2015.Abstract 8574.
[http://dx.doi.org/www.myelomabeacon.com/docs/asco2015/8574.pdf]
[51]
Veillette, A.; Guo, H. CS1, a SLAM family receptor involved in immune regulation, is a therapeutic target in multiple myeloma. Crit. Rev. Oncol. Hematol., 2013, 88(1), 168-177.
[http://dx.doi.org/10.1016/j.critrevonc.2013.04.003] [PMID: 23731618]
[52]
Cruz-Munoz, M-E.; Dong, Z.; Shi, X.; Zhang, S.; Veillette, A. Influence of CRACC, a SLAM family receptor coupled to the adaptor EAT-2, on natural killer cell function. Nat. Immunol., 2009, 10(3), 297-305.
[http://dx.doi.org/10.1038/ni.1693] [PMID: 19151721]
[53]
Tai, Y-T.; Dillon, M.; Song, W.; Leiba, M.; Li, X.F.; Burger, P.; Lee, A.I.; Podar, K.; Hideshima, T.; Rice, A.G.; van Abbema, A.; Jesaitis, L.; Caras, I.; Law, D.; Weller, E.; Xie, W.; Richardson, P.; Munshi, N.C.; Mathiot, C.; Avet-Loiseau, H.; Afar, D.E.; Anderson, K.C. Anti-CS1 humanized monoclonal antibody HuLuc63 inhibits myeloma cell adhesion and induces antibody-dependent cellular cytotoxicity in the bone marrow milieu. Blood, 2008, 112(4), 1329-1337.
[http://dx.doi.org/10.1182/blood-2007-08-107292] [PMID: 17906076]
[54]
Zonder, J.A.; Mohrbacher, A.F.; Singhal, S.; van Rhee, F.; Bensinger, W.I.; Ding, H.; Fry, J.; Afar, D.E.; Singhal, A.K. A phase 1, multicenter, open-label, dose escalation study of elotuzumab in patients with advanced multiple myeloma. Blood, 2012, 120(3), 552-559.
[http://dx.doi.org/10.1182/blood-2011-06-360552] [PMID: 22184404]
[55]
Lonial, S.; Vij, R.; Harousseau, J-L.; Facon, T.; Moreau, P.; Mazumder, A.; Kaufman, J.L.; Leleu, X.; Tsao, L.C.; Westland, C.; Singhal, A.K.; Jagannath, S. Elotuzumab in combination with lenalidomide and low-dose dexamethasone in relapsed or refractory multiple myeloma. J. Clin. Oncol., 2012, 30(16), 1953-1959.
[http://dx.doi.org/10.1200/JCO.2011.37.2649] [PMID: 22547589]
[56]
Jakubowiak, A.; Offidani, M.; Pégourie, B.; De La Rubia, J.; Garderet, L.; Laribi, K.; Bosi, A.; Marasca, R.; Laubach, J.; Mohrbacher, A.; Carella, A.M.; Singhal, A.K.; Tsao, L.C.; Lynch, M.; Bleickardt, E.; Jou, Y.M.; Robbins, M.; Palumbo, A. Randomized phase 2 study: elotuzumab plus bortezomib/dexamethasone vs bortezomib/dexamethasone for relapsed/refractory MM. Blood, 2016, 127(23), 2833-2840.
[http://dx.doi.org/10.1182/blood-2016-01-694604] [PMID: 27091875]
[57]
Lonial, S.; Dimopoulos, M.; Palumbo, A.; White, D.; Grosicki, S.; Spicka, I.; Walter-Croneck, A.; Moreau, P.; Mateos, M.V.; Magen, H.; Belch, A.; Reece, D.; Beksac, M.; Spencer, A.; Oakervee, H.; Orlowski, R.Z.; Taniwaki, M.; Röllig, C.; Einsele, H.; Wu, K.L.; Singhal, A.; San-Miguel, J.; Matsumoto, M.; Katz, J.; Bleickardt, E.; Poulart, V.; Anderson, K.C.; Richardson, P. Elotuzumab therapy for relapsed or refractory multiple myeloma. N. Engl. J. Med., 2015, 373(7), 621-631.
[http://dx.doi.org/10.1056/NEJMoa1505654] [PMID: 26035255]
[58]
Dimopoulos, M.A.; Lonial, S.; White, D. Phase 3 Eloquent-2 Study: Extended 4-Year Follow-Up of Elotuzumab Plus Lenalidomide/Dexamethasone Vs Lenalidomide/Dexamethasone in Relapsed/Refractory Multiple Myeloma. Eur. Hematol. Assoc; EHA Learning Center: Madrid, 2017, p. 181754.Available at:. https://learningcenter.ehaweb.org/eha/2017/22nd/18 1743/meletios.a.dimopoulos.phase.3.eloquent-2.study.extended.4-year.follow-up.of.html [Accessed: 2018 Feb 1]
[59]
Hanahan, D.; Weinberg, R.A. Hallmarks of Cancer: The Next Generation. Cell, 2011, 144(5), 646-674.
[http://dx.doi.org/10.1016/j.cell.2011.02.013] [PMID: 21376230]
[60]
Riley, J.L. PD-1 signaling in primary T cells. Immunol. Rev., 2009, 229(1), 114-125.
[http://dx.doi.org/10.1111/j.1600-065X.2009.00767.x] [PMID: 19426218]
[61]
Day, C.L.; Kaufmann, D.E.; Kiepiela, P.; Brown, J.A.; Moodley, E.S.; Reddy, S.; Mackey, E.W.; Miller, J.D.; Leslie, A.J.; DePierres, C.; Mncube, Z. Duraiswamy. J.; Zhu, B.; Eichbaum, Q.; Altfeld, M.; Wherry, E.J.; Coovadia, H.M.; Goulder, P.J.; Klenerman, P.; Ahmed, R.; Freeman, G.J.; Walker, B.D. PD-1 expression on HIV-specific T cells is associated with T-cell exhaustion and disease progression. Nature, 2006, 443(7019), 350-354.
[http://dx.doi.org/10.1038/nature05115] [PMID: 16921384]
[62]
Nishimura, H.; Nose, M.; Hiai, H.; Minato, N.; Honjo, T. Development of lupus-like autoimmune diseases by disruption of the PD-1 gene encoding an ITIM Motif-carrying immunoreceptor. Immunity, 1999, 11(2), 141-151.
[http://dx.doi.org/10.1016/s1074-7613(00)80089-8] [PMID: 10485649]
[63]
Latchman, Y.; Wood, C.R.; Chernova, T.; Chaudhary, D.; Borde, M.; Chernova, I.; Iwai, Y.; Long, A.J.; Brown, J.A.; Nunes, R.; Greenfield, E.A.; Bourque, K.; Boussiotis, V.A.; Carter, L.L.; Carreno, B.M.; Malenkovich, N.; Nishimura, H.; Okazaki, T.; Honjo, T.; Sharpe, A.H.; Freeman, G.J. PD-L2 is a second ligand for PD-1 and inhibits T cell activation. Nat. Immunol., 2001, 2(3), 261-268.
[http://dx.doi.org/10.1038/85330] [PMID: 11224527]
[64]
Brahmer, J.R.; Drake, C.G.; Wollner, I.; Powderly, J.D.; Picus, J.; Sharfman, W.H.; Stankevich, E.; Pons, A.; Salay, T.M.; McMiller, T.L.; Gilson, M.M.; Wang, C.; Selby, M.; Taube, J.M.; Anders, R.; Chen, L.; Korman, A.J.; Pardoll, D.M.; Lowy, I.; Topalian, S.L. Phase I study of single-agent anti-programmed death-1 (MDX-1106) in refractory solid tumors: safety, clinical activity, pharmacodynamics, and immunologic correlates. J. Clin. Oncol., 2010, 28(19), 3167-3175.
[http://dx.doi.org/10.1200/JCO.2009.26.7609] [PMID: 20516446]
[65]
OPDIVO® (nivolumab) injection, for intravenous use - Full prescribing information. Available at:. https://packageinserts.bms.com/pi/pi_opdivo.pdf [Accessed: 2017 December14]
[66]
Lesokhin, A.M.; Ansell, S.M.; Armand, P.; Scott, E.C.; Halwani, A.; Gutierrez, M.; Millenson, M.M.; Cohen, A.D.; Schuster, S.J.; Lebovic, D.; Dhodapkar, M.; Avigan, D.; Chapuy, B.; Ligon, A.H.; Freeman, G.J.; Rodig, S.J.; Cattry, D.; Zhu, L.; Grosso, J.F.; Bradley Garelik, M.B.; Shipp, M.A.; Borrello, I.; Timmerman, J. Nivolumab in patients with relapsed or refractory hematologic malignancy: preliminary results of a Phase Ib Study. J. Clin. Oncol., 2016, 34(23), 2698-2704.
[http://dx.doi.org/10.1200/JCO.2015.65.9789] [PMID: 27269947]
[67]
Funt, S.A.; Page, D.B.; Cattry, D.; Lendvai, N.; Hassoun, H.; Landgren, O.; Borrello, I.M.; Lesokhin, A.M. The long PD-1 receptor binding kinetics of Nivolumab may increase efficacy of subsequent therapy in relapsed and refractory multiple myeloma patients. Blood, 2015, 126(23), 3057.
[http://dx.doi.org/10.1182/blood.V126.23.3057.3057]
[68]
Ahamadi, M.; Freshwater, T.; Prohn, M.; Li, C.H.; de Alwis, D.P.; de Greef, R.; Elassaiss-Schaap, J.; Kondic, A.; Stone, J.A. 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.
[http://dx.doi.org/10.1002/psp4.12139] [PMID: 27863186]
[69]
Mateos, M-V.; Orlowski, R.Z.; Siegel, D.S.D.; Reece, D.A.; Moreau, P.; Ocio, E.M.; Shah, J.J.; Rodríguez-Otero, P.; Munshi, N.C.; Avigan, D.; Ge, J.Y.; Marinello, P.M.; Miguel, J.S. Pembrolizumab in combination with lenalidomide and low-dose dexamethasone for relapsed/refractory multiple myeloma (RRMM): Final efficacy and safety analysis. J. Clin. Oncol., 2016, 34(Suppl. 15), 8010.
[http://dx.doi.org/10.1200/JCO.2016.34.15_suppl.8010]
[70]
Badros, A.; Hyjek, E.; Ma, N.; Lesokhin, A.; Dogan, A.; Rapoport, A.P.; Kocoglu, M.; Lederer, E.; Philip, S.; Milliron, T.; Dell, C.; Goloubeva, O.; Singh, Z. Pembrolizumab, pomalidomide, and low-dose dexamethasone for relapsed/refractory multiple myeloma. Blood, 2017, 130(10), 1189-1197.
[http://dx.doi.org/10.1182/blood-2017-03-775122] [PMID: 28461396]
[71]
U.S. Food & Drug Administration [FDA] - Center for Drug Evaluation and Research. FDA Alerts Healthcare Professionals and Oncology Clinical Investigators about Two Clinical Trials on Hold Evaluating KEYTRUDA® (pembrolizumab) in Patients with Multiple Myeloma. Available from:. https://www.fda.gov/Drugs/DrugSafety/ucm574305.htm [Accessed: 2017 Dec 15]
[72]
Baverel, P.; Dubois, V.; Jin, C.; Xuyang, Song.; Jin, X.; Mukhopadhyay, P.; Gupta, A.K.; Dennis, P.A.; Ben, Y.; Roskos, L.; Narwal, R. Population pharmacokinetics of durvalumab and fixed dosing regimens in patients with advanced solid tumors. J. Clin. Oncol., 2017, 35(Suppl. 15), 2566.
[http://dx.doi.org/10.1200/JCO.2017.35.15_suppl.2566]
[73]
Dimopoulos, M.A.; Lonial, S.; White, D.; Moreau, P.; Palumbo, A.; Miguel, J.S.; Shpilberg, O.; Anderson, K.C.; Grosicki, S.; Spicka, I.; Walter-Croneck, A.; Magen-Nativ, H.; Mateos, M-V.; Belch, A.; Reece, D.; Beksac, M.; Bleickhardt, E.; Poulart, V.; Katz, J.; Singhal, A.K.; Richardson, P.G. Eloquent-2 update: A Phase 3, randomized, open-label study of elotuzumab in combination with lenalidomide/dexamethasone in patients with relapsed/refractory multiple myeloma - 3-year safety and efficacy follow-up. Blood, 2015, 126(23), 28.
[http://dx.doi.org/10.1182/blood.V126.23.28.28]
[74]
DARZALEX®(daratumumab) injection, for intravenous use. Full Prescribing Information 2017. Available from:. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761036s005lbl.pdf [Accessed: 2017 Dec 15]
[75]
Gibiansky, L.; Passey, C.; Roy, A.; Bello, A.; Gupta, M. Model-based pharmacokinetic analysis of elotuzumab in patients with relapsed/refractory multiple myeloma. J. Pharmacokinet. Pharmacodyn., 2016, 43(3), 243-257.
[http://dx.doi.org/10.1007/s10928-016-9469-x] [PMID: 26993283]
[76]
Waddell, J.A.; Solimando, D.A. Jr. Alectinib, Ceritinib, Elotuzumab, and Venetoclax. Hosp. Pharm., 2016, 51(7), 524-534.
[http://dx.doi.org/10.1310/hpj5107-524] [PMID: 27559185]
[77]
Elassaiss-Schaap, J.; Rossenu, S.; Lindauer, A.; Kang, S.P.; de Greef, R.; Sachs, J.R.; de Alwis, D.P. 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.
[http://dx.doi.org/10.1002/psp4.12132] [PMID: 27863143]
[78]
Freshwater, T.; Kondic, A.; Ahamadi, M.; Li, C.H.; de Greef, R.; de Alwis, D.; Stone, J.A. Evaluation of dosing strategy for pembrolizumab for oncology indications. J. Immunother. Cancer, 2017, 5, 43.
[http://dx.doi.org/10.1186/s40425-017-0242-5] [PMID: 28515943]
[79]
Bajaj, G.; Wang, X.; Agrawal, S.; Gupta, M.; Roy, A.; Feng, Y. Model-based population pharmacokinetic analysis of Nivolumab in patients with solid tumors. CPT Pharmacometrics Syst. Pharmacol., 2017, 6(1), 58-66.
[http://dx.doi.org/10.1002/psp4.12143] [PMID: 28019091]
[80]
Yamamoto, N.; Nokihara, H.; Yamada, Y.; Shibata, T.; Tamura, Y.; Seki, Y.; Honda, K.; Tanabe, Y.; Wakui, H.; Tamura, T. Phase I study of Nivolumab, an anti-PD-1 antibody, in patients with malignant solid tumors. Invest. New Drugs, 2017, 35(2), 207-216.
[http://dx.doi.org/10.1007/s10637-016-0411-2] [PMID: 27928714]
[81]
Jeanson, A.; Barlesi, F. MEDI 4736 (durvalumab) in non-small cell lung cancer. Expert Opin. Biol. Ther., 2017, 17(10), 1317-1323.
[http://dx.doi.org/10.1080/14712598.2017.1351939] [PMID: 28705024]

Rights & Permissions Print Cite
© 2024 Bentham Science Publishers | Privacy Policy