1,947
Views
6
CrossRef citations to date
0
Altmetric
Original Articles

Glofitamab CD20-TCB bispecific antibody

&
Pages 3098-3108 | Received 13 May 2021, Accepted 29 Jun 2021, Published online: 15 Jul 2021

References

  • Palanca-Wessels MC, Czuczman M, Salles G, et al. Safety and activity of the anti-CD79B antibody-drug conjugate polatuzumab vedotin in relapsed or refractory B-cell non-Hodgkin lymphoma and chronic lymphocytic leukaemia: a phase 1 study. Lancet Oncol. 2015;16(6):704–715.
  • Gisselbrecht C, Van Den Neste E. How I manage patients with relapsed/refractory diffuse large B cell lymphoma. Br J Haematol. 2018;182(5):633–643.
  • Coiffier B, Thieblemont C, Van Den Neste E, et al. Long-term outcome of patients in the LNH-98.5 trial, the first randomized study comparing rituximab-CHOP to standard CHOP chemotherapy in DLBCL patients: a study by the Groupe d'Etudes des Lymphomes de l'Adulte. Blood. 2010;116(12):2040–2045.
  • Crump M, Neelapu SS, Farooq U, et al. Outcomes in refractory diffuse large B-cell lymphoma: results from the international SCHOLAR-1 study. Blood. 2017;130(16):1800–1808.
  • Perez P, Hoffman RW, Shaw S, et al. Specific targeting of cytotoxic T cells by anti-T3 linked to anti-target cell antibody. Nature. 1985;316(6026):354–356.
  • Brinkmann U, Kontermann RE. The making of bispecific antibodies. MAbs. 2017;9(2):182–212.
  • Jen EY, Xu Q, Schetter A, et al. FDA approval: blinatumomab for patients with B-cell precursor acute lymphoblastic leukemia in morphologic remission with minimal residual disease. Clin Cancer Res. 2019;25(2):473–477.
  • Kantarjian H, Stein A, Gökbuget N, et al. Blinatumomab versus chemotherapy for advanced acute lymphoblastic leukemia. N Engl J Med. 2017;376(9):836–847.
  • Nalivaiko K, Hofmann M, Kober K, et al. A recombinant bispecific CD20 × CD95 antibody with superior activity against normal and malignant B-cells. Mol Ther. 2016;24(2):298–305.
  • Zeng J, Liu R, Wang J, et al. A bispecific antibody directly induces lymphoma cell death by simultaneously targeting CD20 and HLA-DR. J Cancer Res Clin Oncol. 2015;141(11):1899–1907.
  • Qi J, Chen SS, Chiorazzi N, et al. An IgG1-like bispecific antibody targeting CD52 and CD20 for the treatment of B-cell malignancies. Methods. 2019;154:70–76.
  • Buatois V, Johnson Z, Salgado-Pires S, et al. Preclinical development of a bispecific antibody that safely and effectively targets CD19 and CD47 for the treatment of B cell lymphoma and leukemia. Mol Cancer Ther. 2018;17(8):1739–1751.
  • Lu C-Y, Chen GJ, Tai P-H, et al. Tetravalent anti-CD20/CD3 bispecific antibody for the treatment of B cell lymphoma. Biochem Biophys Res Commun. 2016;473(4):808–813.
  • Lugtenburg P, Mous R, Clausen MR, et al. First-in-human, phase 1/2 trial to assess the safety and clinical activity of subcutaneous GEN3013 (DuoBody®-CD3 × CD20) in B-cell non-Hodgkin lymphomas. Blood. 2019;134(Supplement_1):758–758.
  • Schuster SJ, Bartlett NL, Assouline S, et al. Mosunetuzumab induces complete remissions in poor prognosis non-Hodgkin lymphoma patients, including those who are resistant to or relapsing after chimeric antigen receptor T-Cell (CAR-T) therapies, and is active in treatment through multiple lines. Blood. 2019;134(Supplement_1):6–6.
  • Bannerji R, Allan JN, Arnason JE, et al. Clinical activity of REGN1979, a bispecific human, anti-CD20 x anti-CD3 antibody, in patients with relapsed/refractory (R/R) B-cell non-Hodgkin lymphoma (B-NHL). Blood. 2019;134(Supplement_1):762–762.
  • Patel K, Michot J-M, Chanan-Khan AA, et al. Preliminary safety and anti-tumor activity of XmAb13676, an anti-CD20 x anti-CD3 bispecific antibody, in patients with relapsed/refractory non-Hodgkin's lymphoma and chronic lymphocytic leukemia. Blood. 2019;134(Supplement_1):4079–4079.
  • Liu L, Lam CYK, Long V, et al. MGD011, a CD19 x CD3 dual affinity re-targeting bi-specific molecule incorporating extended circulating half-life for the treatment of B-cell Malignancies. Clin Cancer Res. 2017;23(6):1506–1518.
  • Malik H, Buelow B, Rangaswamy U, et al. TNB-486, a novel fully human bispecific CD19 x CD3 antibody that kills CD19-positive tumor cells with minimal cytokine secretion. Blood. 2019;134(Supplement_1):4070–4070.
  • Cui Y, Huang Z, Zhang X, et al. CD3-activating bi-specific antibody targeting CD19 on B cells in mono- and bi-valent format. Blood. 2018;132(Supplement 1):4169–4169.
  • Ellerman D. Bispecific T-cell engagers: towards understanding variables influencing the in vitro potency and tumor selectivity and their modulation to enhance their efficacy and safety. Methods. 2019;154:102–117.
  • Lejeune M, Köse MC, Duray E, et al. Bispecific, T-cell-recruiting antibodies in B-cell malignancies. Front Immunol. 2020;11:762.
  • Trivedi A, Stienen S, Zhu M, et al. Clinical pharmacology and translational aspects of bispecific antibodies. Clin Transl Sci. 2017;10(3):147–162.
  • Fan G, Wang Z, Hao M, et al. Bispecific antibodies and their applications. J Hematol Oncol. 2015;8:130–130.
  • Dahlén E, Veitonmäki N, Norlén P. Bispecific antibodies in cancer immunotherapy. Ther Adv Vaccines Immunother. 2018;6(1):3–17.
  • Bacac M, Colombetti S, Herter S, et al. CD20-TCB with obinutuzumab pretreatment as Next-generation treatment of hematologic malignancies. Clin Cancer Res. 2018;24(19):4785–4797.
  • Cremasco F, Menietti E, Speziale D, et al. Cross-linking of T cell to B cell lymphoma by the T cell bispecific antibody CD20-TCB induces IFNγ/CXCL10-dependent peripheral T cell recruitment in humanized murine model. PLoS One. 2021;16(1):e0241091.
  • Djebli N, Jaminion F, Laurent J, et al. Population pharmacokinetics and novel exposure-response analyses to inform optimal biologic dose selection for CD20-TCB, a T-Cell-engaging bispecific antibody, in relapsed or refractory B-cell non-Hodgkin lymphoma. Blood. 2019;134(Supplement_1):3799–3799.
  • Bacac M, Umaña P, Herter S, et al. CD20 Tcb (RG6026), a novel "2:1" T cell bispecific antibody for the treatment of B cell malignancies. Blood. 2016;128(22):1836–1836.
  • Schlothauer T, Herter S, Koller CF, et al. Novel human IgG1 and IgG4 Fc-engineered antibodies with completely abolished immune effector functions. Protein Eng Des Sel. 2016;29(10):457–466.
  • Hutchings M, Morschhauser F, Iacoboni G, et al. Glofitamab, a novel, bivalent CD20-targeting T-Cell-engaging bispecific antibody, induces durable complete remissions in relapsed or refractory B-cell lymphoma: a phase I trial. J Clin Oncol. 2021;39(18):1959–1970.
  • Bacac M, Klein C, Umana P. CEA TCB: A novel head-to-tail 2:1 T cell bispecific antibody for treatment of CEA-positive solid tumors. Oncoimmunology. 2016;5(8):e1203498.
  • Bröske A-ME, James I, Belousov A, et al. CD20-TCB, a novel T-cell-engaging bispecific antibody, induces T-cell-mediated killing in relapsed or refractory non-Hodgkin lymphoma: biomarker results from a phase I dose-escalation trial. Blood. 2019;134(Supplement_1):5319–5319.
  • Bröske A-ME, Korfi K, Belousov A, et al. CD20-TCB induces T-cell activation and T-cell-mediated tumour cell killing in patient with relapsed or refractory non-Hodgkin lymphoma: biomarker results from a phase I study. HemaSphere. 2020;4:609–610.
  • Hutchings M, Carlo-Stella C, Bachy E, et al. Glofitamab step-up dosing induces high response rates in patients with hard-to-treat refractory or relapsed non-Hodgkin lymphoma. Blood. 2020;136(Supplement 1):46–48.
  • Dickinson MJ, Morschhauser F, Iacoboni G, et al. CD20-TCB (RG6026), a novel “2:1” format T-cell-engaging bispecific antibody, induces complete remissions in relapsed/refractory B-cell non-Hodgkin's lymphoma. Hematol Oncol. 2019;37:92–93.
  • Morschhauser F, Carlo-Stella C, Offner F, et al. Dual CD20-targeted therapy with concurrent CD20-TCB and obinutuzumab shows highly promising clinical activity and manageable safety in relapsed or refractory B-cell non-Hodgkin lymphoma: preliminary results from a phase Ib trial. Blood. 2019;134(Supplement_1):1584–1584.
  • Neelapu SS, Locke FL, Bartlett NL, et al. Axicabtagene Ciloleucel CAR T-cell therapy in refractory large B-cell lymphoma. N Engl J Med. 2017;377(26):2531–2544.
  • Schuster SJ, Bishop MR, Tam CS, JULIET Investigators, et al. Tisagenlecleucel in adult relapsed or refractory diffuse large B-cell lymphoma. N Engl J Med. 2019;380(1):45–56.
  • Hutchings M, Gritti G, Sureda A, et al. CD20-TCB, a novel T-cell-engaging bispecific antibody, can be safely combined with the anti-PD-L1 antibody atezolizumab in relapsed or refractory B-cell non-Hodgkin lymphoma. Blood. 2019;134(Supplement_1):2871–2871.
  • Brudno JN, Kochenderfer JN. Toxicities of chimeric antigen receptor T cells: recognition and management. Blood. 2016;127(26):3321–3330.
  • Maude SL, Barrett D, Teachey DT, et al. Managing cytokine release syndrome associated with novel T cell-engaging therapies. Cancer J. 2014;20(2):119–122.
  • Neelapu SS, Tummala S, Kebriaei P, et al. Chimeric antigen receptor T-cell therapy – assessment and management of toxicities. Nat Rev Clin Oncol. 2018;15(1):47–62.
  • Xie G, Dong H, Liang Y, et al. CAR-NK cells: A promising cellular immunotherapy for cancer. EBioMedicine. 2020; 59:102975.
  • Basar R, Daher M, Rezvani K. Next-generation cell therapies: the emerging role of CAR-NK cells. Blood Adv. 2020;4(22):5868–5876.
  • Rothe A, Sasse S, Topp MS, et al. A phase 1 study of the bispecific anti-CD30/CD16A antibody construct AFM13 in patients with relapsed or refractory Hodgkin lymphoma. Blood. 2015;125(26):4024–4031.
  • Wang Z, Han W. Biomarkers of cytokine release syndrome and neurotoxicity related to CAR-T cell therapy. Biomark Res. 2018;6:4–4.
  • Frey N, Porter D. Cytokine release syndrome with chimeric antigen receptor T cell therapy. Biol Blood Marrow Transplant. 2019;25(4):e123–e127.
  • Lee DW, Santomasso BD, Locke FL, et al. ASTCT consensus grading for cytokine release syndrome and neurologic toxicity associated with immune effector cells. Biol Blood Marrow Transplant. 2019;25(4):625–638.
  • Li J, Piskol R, Ybarra R, et al. CD3 bispecific antibody–induced cytokine release is dispensable for cytotoxic T cell activity. Sci Transl Med. 2019;11(508):eaax8861.
  • Strohl N. Bispecific T-cell redirection versus chimeric antigen receptor (CAR)-T cells as approaches to kill cancer cells. Antibodies. 2019;8(3):41.
  • Przepiorka D, Ko C-W, Deisseroth A, et al. FDA approval: blinatumomab. Clin Cancer Res. 2015;21(18):4035–4039.
  • Yu J, Wang W, Huang H. Efficacy and safety of bispecific T-cell engager (BiTE) antibody blinatumomab for the treatment of relapsed/refractory acute lymphoblastic leukemia and non-Hodgkin’s lymphoma: a systemic review and meta-analysis. Hematology. 2019;24(1):199–207.
  • Liu S, Deng B, Yin Z, et al. Corticosteroids do not influence the efficacy and kinetics of CAR-T cells for B-cell acute lymphoblastic leukemia. Blood Cancer J. 2020;10(2):15.
  • Gardner RA, Ceppi F, Rivers J, et al. Preemptive mitigation of CD19 CAR T-cell cytokine release syndrome without attenuation of antileukemic efficacy. Blood. 2019;134(24):2149–2158.
  • Topp MS, van Meerten T, Wermke M, et al. Preliminary results of earlier steroid use with axicabtagene ciloleucel (axi-cel) in patients with relapsed/refractory large B-cell lymphoma (R/R LBCL). J Clin Oncol. 2019;37(15_suppl):7558–7558.
  • Le RQ, Li L, Yuan W, et al. FDA approval summary: tocilizumab for treatment of chimeric antigen receptor T cell-induced severe or life-threatening cytokine release syndrome. The Oncol. 2018;23(8):943–947.
  • Si S, Teachey DT. Spotlight on tocilizumab in the treatment of CAR-T-cell-induced cytokine release syndrome: clinical evidence to date. Ther Clin Risk Manag. 2020;16:705–714.
  • Yakoub-Agha I, Chabannon C, Bader P, et al. Management of adults and children undergoing chimeric antigen receptor T-cell therapy: best practice recommendations of the European Society for Blood and Marrow Transplantation (EBMT) and the Joint Accreditation Committee of ISCT and EBMT (JACIE). Haematologica. 2020;105(2):297–316.
  • Jain T, Litzow MR. Management of toxicities associated with novel immunotherapy agents in acute lymphoblastic leukemia. Ther Adv Hematol. 2020;11:2040620719899897.
  • Otáhal P, Průková D, Král V, et al. Lenalidomide enhances antitumor functions of chimeric antigen receptor modified T cells. Oncoimmunology. 2016;5(4):e1115940.
  • Gandhi AK, Kang J, Havens CG, et al. Immunomodulatory agents lenalidomide and pomalidomide co-stimulate T cells by inducing degradation of T cell repressors Ikaros and Aiolos via modulation of the E3 ubiquitin ligase complex CRL4(CRBN.). Br J Haematol. 2014;164(6):811–821.
  • Schafer PH, Gandhi AK, Loveland MA, et al. Enhancement of cytokine production and AP-1 transcriptional activity in T cells by thalidomide-related immunomodulatory drugs. J Pharmacol Exp Ther. 2003;305(3):1222–1232.
  • Kritharis A, Coyle M, Sharma J, et al. Lenalidomide in non-Hodgkin lymphoma: biological perspectives and therapeutic opportunities. Blood. 2015;125(16):2471–2476.
  • Ruella M, Kenderian SS, Shestova O, et al. The addition of the BTK inhibitor ibrutinib to anti-CD19 chimeric antigen receptor T cells (CART19) improves responses against mantle cell lymphoma. Clin Cancer Res. 2016;22(11):2684–2696.
  • Fraietta JA, Beckwith KA, Patel PR, et al. Ibrutinib enhances chimeric antigen receptor T-cell engraftment and efficacy in leukemia. Blood. 2016;127(9):1117–1127.
  • Gill SI, Vides V, Frey NV, et al. Prospective clinical trial of anti-CD19 CAR T cells in combination with ibrutinib for the treatment of chronic lymphocytic leukemia shows a high response rate. Blood. 2018;132(Supplement 1):298–298.
  • Gauthier J, Hirayama AV, Purushe J, et al. Feasibility and efficacy of CD19-targeted CAR T cells with concurrent ibrutinib for CLL after ibrutinib failure. Blood. 2020;135(19):1650–1660.
  • Correnti CE, Laszlo GS, de van der Schueren WJ, et al. Simultaneous multiple interaction T-cell engaging (SMITE) bispecific antibodies overcome bispecific T-cell engager (BiTE) resistance via CD28 co-stimulation. Leukemia. 2018;32(5):1239–1243.
  • Laszlo GS, Gudgeon CJ, Harrington KH, et al. T-cell ligands modulate the cytolytic activity of the CD33/CD3 BiTE antibody construct, AMG 330. Blood Cancer J. 2015;5(8):e340.
  • Sanchez-Paulete AR, Labiano S, Rodriguez-Ruiz ME, et al. Deciphering CD137 (4-1BB) signaling in T-cell costimulation for translation into successful cancer immunotherapy. Eur J Immunol. 2016;46(3):513–522.
  • Maude SL, Frey N, Shaw PA, et al. Chimeric antigen receptor T cells for sustained remissions in leukemia. N Engl J Med. 2014;371(16):1507–1517.
  • Braig F, Brandt A, Goebeler M, et al. Resistance to anti-CD19/CD3 BiTE in acute lymphoblastic leukemia may be mediated by disrupted CD19 membrane trafficking. Blood. 2017;129(1):100–104.
  • Mejstríková E, Hrusak O, Borowitz MJ, et al. CD19-negative relapse of pediatric B-cell precursor acute lymphoblastic leukemia following blinatumomab treatment. Blood Cancer J. 201;7(12):659.
  • Ruella M, Maus MV. Catch me if you can: leukemia escape after CD19-directed T cell immunotherapies. Comput Struct Biotechnol J. 2016;14:357–362.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.