DRAFT - Phase 1 Study of AME-133v in Patients with ... · Results of a Phase 1 Study of AME-133v (LY2469298) an Fc-Engineered Humanized Monoclonal Anti-CD20 Antibody, in FcγRIIIa-Genotyped
This document is posted to help you gain knowledge. Please leave a comment to let me know what you think about it! Share it to your friends and learn new things together.
Transcript
DRAFT - Phase 1 Study of AME-133v in Patients with Follicular Lymphoma
CONFIDENTIAL 1
Title:
Results of a Phase 1 Study of AME-133v (LY2469298) an Fc-Engineered Humanized Monoclonal Anti-
CD20 Antibody, in FcγRIIIa-Genotyped Patients with Previously Treated Follicular Lymphoma
Running Title: Phase 1 Study of AME-133v in Patients with Follicular Lymphoma Key Words: Anti-CD20 Previously treated Non-Hodgkin’s Lymphoma AME-133v Monoclonal Antibody FcγRIIIa Authors: Andres Forero-Torres1, Sven de Vos2, Brad L. Pohlman3, Maksim Pashkevich4, ,Damien M. Cronier5, Nam H. Dang6, Susan P. Carpenter7, Barrett W. Allan7, James G. Nelson7, Christopher A. Slapak4, Mitchell R. Smith8, Brian K. Link9, James E. Wooldridge4, Kristen N. Ganjoo10
Authors Affiliations: 1University of Alabama at Birmingham, Birmingham, Alabama 2David Geffen School of Medicine at University of California Los Angeles, Los Angeles, California 3Cleveland Clinic Taussig Cancer Institute, Cleveland, Ohio 4Eli Lilly and Company, Indianapolis, Indiana 5Eli Lilly and Company, Windlesham, United Kingdom 6University of Florida, Gainseville, Florida 7Applied Molecular Evolution, San Diego, California 8Fox Chase Cancer Center, Philadelphia, Pennsylvania 9Holden Comprehensive Cancer Center at University of Iowa, Iowa City, Iowa 10Stanford University Cancer Center, Palo Alto, California Reprint Requests: 7Susan Carpenter, PhD Applied Molecular Evolution Lilly Biotechnology Center-San Diego 10300 Campus Point Drive, Suite 200 San Diego, CA 92121 [email protected]
Author manuscripts have been peer reviewed and accepted for publication but have not yet been edited. Author Manuscript Published OnlineFirst on January 5, 2012; DOI: 10.1158/1078-0432.CCR-11-0850
Author manuscripts have been peer reviewed and accepted for publication but have not yet been edited. Author Manuscript Published OnlineFirst on January 5, 2012; DOI: 10.1158/1078-0432.CCR-11-0850
Author manuscripts have been peer reviewed and accepted for publication but have not yet been edited. Author Manuscript Published OnlineFirst on January 5, 2012; DOI: 10.1158/1078-0432.CCR-11-0850
Author manuscripts have been peer reviewed and accepted for publication but have not yet been edited. Author Manuscript Published OnlineFirst on January 5, 2012; DOI: 10.1158/1078-0432.CCR-11-0850
Author manuscripts have been peer reviewed and accepted for publication but have not yet been edited. Author Manuscript Published OnlineFirst on January 5, 2012; DOI: 10.1158/1078-0432.CCR-11-0850
Author manuscripts have been peer reviewed and accepted for publication but have not yet been edited. Author Manuscript Published OnlineFirst on January 5, 2012; DOI: 10.1158/1078-0432.CCR-11-0850
Author manuscripts have been peer reviewed and accepted for publication but have not yet been edited. Author Manuscript Published OnlineFirst on January 5, 2012; DOI: 10.1158/1078-0432.CCR-11-0850
Author manuscripts have been peer reviewed and accepted for publication but have not yet been edited. Author Manuscript Published OnlineFirst on January 5, 2012; DOI: 10.1158/1078-0432.CCR-11-0850
Author manuscripts have been peer reviewed and accepted for publication but have not yet been edited. Author Manuscript Published OnlineFirst on January 5, 2012; DOI: 10.1158/1078-0432.CCR-11-0850
Author manuscripts have been peer reviewed and accepted for publication but have not yet been edited. Author Manuscript Published OnlineFirst on January 5, 2012; DOI: 10.1158/1078-0432.CCR-11-0850
Author manuscripts have been peer reviewed and accepted for publication but have not yet been edited. Author Manuscript Published OnlineFirst on January 5, 2012; DOI: 10.1158/1078-0432.CCR-11-0850
Author manuscripts have been peer reviewed and accepted for publication but have not yet been edited. Author Manuscript Published OnlineFirst on January 5, 2012; DOI: 10.1158/1078-0432.CCR-11-0850
Author manuscripts have been peer reviewed and accepted for publication but have not yet been edited. Author Manuscript Published OnlineFirst on January 5, 2012; DOI: 10.1158/1078-0432.CCR-11-0850
Author manuscripts have been peer reviewed and accepted for publication but have not yet been edited. Author Manuscript Published OnlineFirst on January 5, 2012; DOI: 10.1158/1078-0432.CCR-11-0850
DRAFT - Phase 1 Study of AME-133v in Patients with Follicular Lymphoma
CONFIDENTIAL 15
References
1. Friedberg JW, Taylor MD, Cerhan JR, Flowers CR, Dillon H, Farber CM, et al. Follicular lymphoma in the United States: first report of the national LymphoCare study. J Clin Oncol 2009;27: 1202-8.
2. Alduaij W, Illidge TM. The future for anti-CD20 monoclonal antibodies: are we making progress? Blood 2011;117:2993-3001.
3. Clynes RA, Towers TL, Presta LG, Ravetch JV. Inhibitory Fc receptors modulate in vivo cytoxicity against tumor targets. Nat Med 2000;6: 443-6.
4. Koene HR, Kleijer M, Algra J, Roos D, von dem Borne AE, de Haas M. Fc gammaRIIIa-158V/F polymorphism influences the binding of IgG by natural killer cell Fc gammaRIIIa, independently of the Fc gammaRIIIa-48L/R/H phenotype. Blood 1997;90: 1109-14.
5. Bowles JA, Weiner GJ. CD16 polymorphisms and NK activation induced by monoclonal antibody-coated target cells. Journal of immunological methods. 2005;304:88-99.
6 Bowles JA, Wang SY, Link BK, Allan B, Beuerlein G, Campbell MA, et al. Anti-CD20 monoclonal antibody with enhanced affinity for CD16 activates NK cells at lower concentrations and more effectively than rituximab. Blood. 2006;108:2648-54.
7. Cartron G, Dacheux L, Salles G, Solal-Celigny P, Bardos P, Colombat P, et al. Therapeutic activity of humanized anti-CD20 monoclonal antibody and polymorphism in IgG Fc receptor FcgammaRIIIa gene. Blood 2002;99: 754-8.
8. Weng WK, Levy R. Two immunoglobulin G fragment C receptor polymorphisms independently predict response to rituximab in patients with follicular lymphoma. J Clin Oncol 2003;21: 3940-7.
9. Ghielmini M, Rufibach K, Salles G, Leoncini-Franscini L, Léger-Falandry C, Cogliatti S, et al. Single agent rituximab in patients with follicular or mantle cell lymphoma: clinical and biological factors that are predictive of response and event-free survival as well as the effect of rituximab on the immune system: a study of the Swiss Group for Clinical Cancer Research (SAKK). Ann Oncol 2005;16: 1675-82.
10. Ralph P, Saiki O, Maurer DH, Welte K. IgM and IgG secretion in human B-cell lines regulated by B-cell-inducing factors (BIF) and phorbol ester. Immunol Lett 1983;7:17-23.
11. Cheson BD, Bennett JM, Grever M, Kay N, Keating MJ, O’Brien S, et al. National Cancer Institute-sponsored Working Group guidelines for chronic lymphocytic leukemia: revised guidelines for diagnosis and treatment. Blood 1996;87: 4990-7.
12. Cheson BD, Horning SJ, Coiffier B, Shipp MA, Fisher RI, Connors JM, et al. Report of an international workshop to standardize response criteria for non-Hodgkin's lymphomas. NCI Sponsored International Working Group. J Clin Oncol 1999;17: 1244.
13. Regazzi MB, Iacona I, Avanzini MA, Arcaini L, Merlini G, Perfetti V, et al. Pharmacokinetic behavior of rituximab: a study of different schedules of administration for heterogeneous clinical settings. Ther Drug Monit 2005;27: 785-92.
Author manuscripts have been peer reviewed and accepted for publication but have not yet been edited. Author Manuscript Published OnlineFirst on January 5, 2012; DOI: 10.1158/1078-0432.CCR-11-0850
DRAFT - Phase 1 Study of AME-133v in Patients with Follicular Lymphoma
CONFIDENTIAL 16
14. Vidal L, Gafter-Gvili A, Leibovici L, Dreyling M, Ghielmini M, Hsu Schmitz SF, et al. Rituximab maintenance for the treatment of patients with follicular lymphoma: systematic review and meta-analysis of randomized trials. J Natl Cancer Inst 2009;101: 248-55.
15. Marcus R, Imrie K, Solal-Celigny P, Catalano JV, Dmoszynska A, Raposo JC, et al. Phase III study of R-CVP compared with cyclophosphamide, vincristine, and prednisone alone in patients with previously untreated advanced follicular lymphoma. J Clin Oncol 2008;26: 4579-86.
16. Salles GA, Catalano J, Feugier P, Offner FC, Bouabdallah R, Caballero D, et al. Rituximab maintenance for 2 years in patients with high tumour burden follicular lymphoma responding to rituximab plus chemotherapy (PRIMA): a phase 3, randomised controlled trial. Lancet 2011;377: 42-51.
17. Fisher RI, LeBlanc M, Press OW, Maloney DG, Unger JM, Miller TP. New treatment options have changed the survival of patients with follicular lymphoma. J Clin Oncol 2005;23: 8447-52.
18. Swenson WT, Wooldridge JE, Lynch CF, Forman-Hoffman VL, Chrischilles E, Link BK. Improved survival of follicular lymphoma patients in the United States. J Clin Oncol. 2005;23: 5019-26.
19. Carlotti E, Palumbo GA, Oldani E, Tibullo D, Salmoiraghi S, Rossi A, et al. FcgammaRIIIA and FcgammaRIIA polymorphisms do not predict clinical outcome of follicular non-Hodgkin's lymphoma patients treated with sequential CHOP and rituximab. Haematologica. 2007;92:1127-30.
20. Maloney DG, Pender-Smith B, Unger JM, Braziel RM, Radich J, Press OW, et al. Fc{gamma} Receptor Polymorphisms Do Not Influence Progression Free Survival (PFS) of Follicular NHL Patients Treated with CHOP Followed by Rituximab (SWOG 9800). Blood 2004;104: Abstract 589.
21. Boettcher S, Pott C, Ritgen M, Hiddemann W, Unterhalt M, Kneba M. Evidence for Fc{gamma} Receptor IIIA-Independent Rituximab Effector Mechanisms in Patients with Follicular Lymphoma Treated with Combined Immuno-Chemotherapy. Blood 2004;104: Abstract 590.
22. Mitrovic Z, Aurer I, Radman I, Ajdukovic R, Sertic J, Labar B. FCgammaRIIIA and FCgammaRIIA polymorphisms are not associated with response to rituximab and CHOP in patients with diffuse large B-cell lymphoma. Haematologica. 2007;92:998-999.
23. Kim DH, Jung HD, Kim JG, Lee JJ, Yang DH, Park YH, et al. FCGR3A gene polymorphisms may correlate with response to frontline R-CHOP therapy for diffuse large B-cell lymphoma. Blood 2006;108: 2720-5.
24. Musolino A, Naldi N, Bortesi B, Pezzuolo D, Capelletti M, Missale G, et al. Immunoglobulin G fragment C receptor polymorphisms and clinical efficacy of trastuzumab-based therapy in patients with HER-2/neu-positive metastatic breast cancer. J Clin Oncol 2008;26: 1789-96.
25. Bibeau F, Lopez-Crapez E, Di Fiore F, Thezenas S, Ychou M, Blanchard F, et al. Impact of Fc{gamma}RIIaFc{gamma}RIIIa polymorphisms and KRAS mutations on the clinical outcome of patients with metastatic colorectal cancer treated with cetuximab plus irinotecan. J Clin Oncol 2009;27: 1122-9.
26. Tobinai K, Ogura M, Kobayashi Y, Uchida T, Watanabe T, Oyama T, et al. Phase I study of LY2469298, an Fc-engineered humanized anti-CD20 antibody, in patients with relapsed or refractory follicular lymphoma. Cancer Sci. 2011;102:432-38.
Author manuscripts have been peer reviewed and accepted for publication but have not yet been edited. Author Manuscript Published OnlineFirst on January 5, 2012; DOI: 10.1158/1078-0432.CCR-11-0850
DRAFT - Phase 1 Study of AME-133v in Patients with Follicular Lymphoma
CONFIDENTIAL 17
27. Lim SH, Beers SA, French RR, Johnson PW, Glennie MJ, Cragg MS. Anti-CD20 monoclonal antibodies: historical and future perspectives. Haematologica 2010;95: 135-43.
28. Goldenberg DM, Rossi EA, Stein R, Cardillo TM, Czuczman MS, Hernandez-Ilizaliturri FJ,et al. Properties and structure-function relationships of veltuzumab (hA20), a humanized anti-CD20 monoclonal antibody. Blood. 2009;113:1062-70.
29. Gravanis I, Ersbøll J, Skovlund E, Abadie E, Marty M, Pignatti F. The European Medicines Agency review of ofatumumab (Arzerra®) for the treatment of chronic lymphocytic leukemia in patients refractory to fludarabine and alemtuzumab: summary of the scientific assessment of the European medicines agency committee for medicinal products for human use. Oncologist. 2010;15:1335-43.
30. Hagenbeek A, Gadeberg O, Johnson P, Pedersen LM, Walewski J, Hellmann A, et al. First clinical use of ofatumumab, a novel fully human anti-CD20 monoclonal antibody in relapsed or refractory follicular lymphoma: results of a phase 1/2 trial. Blood. 2008;111:5486-95.
31. Mossner E, Brunker P, Moser S, Puntener U, Schmidt C, Herter S, et al. Increasing the efficacy of CD20 antibody therapy through the engineering of a new type II anti-CD20 antibody with enhanced direct and immune effector cell-mediated B-cell cytotoxicity. Blood. 2010;115:4393-4402.
32. Morschhauser F, Marlton P, Vitolo U, Linden O, Seymour J, Crump M, et al. Interim Results of a phase I/II study of ocrelizumab, a new humanised anti-CD20 antibody in patients with relapsed/refractory follicular non-Hodgkin’s lymphoma. Blood. 2007 110: Abstract 645.
33. Morschhauser F, Marlton P, Vitolo U, Lindén O, Seymour JF, Crump M, et al. Results of a phase I/II study of ocrelizumab, a fully humanized anti-CD20 mAb, in patients with relapsed/refractory follicular lymphoma. Ann Oncol. 2010 21:1870-76.
Author manuscripts have been peer reviewed and accepted for publication but have not yet been edited. Author Manuscript Published OnlineFirst on January 5, 2012; DOI: 10.1158/1078-0432.CCR-11-0850
Author manuscripts have been peer reviewed and accepted for publication but have not yet been edited. Author Manuscript Published OnlineFirst on January 5, 2012; DOI: 10.1158/1078-0432.CCR-11-0850
Author manuscripts have been peer reviewed and accepted for publication but have not yet been edited. Author Manuscript Published OnlineFirst on January 5, 2012; DOI: 10.1158/1078-0432.CCR-11-0850
Author manuscripts have been peer reviewed and accepted for publication but have not yet been edited. Author Manuscript Published OnlineFirst on January 5, 2012; DOI: 10.1158/1078-0432.CCR-11-0850
Published OnlineFirst January 5, 2012.Clin Cancer Res Andres Forero-Torres, Sven de Vos, Brad L Pohlman, et al. Patients with Previously Treated Follicular Lymphoma
RIIIa-GenotypedγHumanized Monoclonal Antibody in FcA Phase 1 Study of AME-133v (LY2469298) an Fc-Engineered
Updated version
10.1158/1078-0432.CCR-11-0850doi:
Access the most recent version of this article at:
To order reprints of this article or to subscribe to the journal, contact the AACR Publications
Permissions
Rightslink site. Click on "Request Permissions" which will take you to the Copyright Clearance Center's (CCC)
.http://clincancerres.aacrjournals.org/content/early/2012/01/05/1078-0432.CCR-11-0850To request permission to re-use all or part of this article, use this link
Author manuscripts have been peer reviewed and accepted for publication but have not yet been edited. Author Manuscript Published OnlineFirst on January 5, 2012; DOI: 10.1158/1078-0432.CCR-11-0850