Phase 1/2 Study of Ocaratuzumab, an Fc-Engineered Humanized Anti-CD20 Monoclonal Antibody, in Low-Affinity FcγRIIIa Patients with Previously Treated Follicular Lymphoma

References

• Alduaij W, Illidge TM. The future of anti-CD20 monoclonal antibodies: are we making progress? Blood 2011;117:2993–3001.
   PubMed Web of Science ®Google Scholar
• Musolino A, Naldi N, Bortesi B, 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;26:1789–1796.
   PubMed Web of Science ®Google Scholar
• Bibeau F, Lopez-Crapez E, Di Fiore F, et al. Impact of Fc{gamma}RIIa-Fc{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 :1122–1129.
   PubMed Web of Science ®Google Scholar
• Clynes RA, Towers TL, Presta LG, et al. Inhibitory Fc receptors modulate in vivo cytotoxicity against tumor targets. Nat Med 2000; 6:443–446.
   PubMed Web of Science ®Google Scholar
• Koene HR, Kleijer M, Algra J, et al. 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;90:1109–1114.
   PubMed Web of Science ®Google Scholar
• Cartron G, Dacheux L, Salles G, et al. Therapeutic activity of humanized anti-CD20 monoclonal antibody and polymorphism in IgG Fc receptor FcgammaRIIIa gene. Blood 2002;99:754–758.
   PubMed Web of Science ®Google Scholar
• Mitroviç Z, Aurer I, Radman I, et al. 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.
   PubMed Web of Science ®Google Scholar
• Carlotti E, Palumbo GA, Oldani E, 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;92:1127–1130.
   PubMed Web of Science ®Google Scholar
• Ghesquiéres H, Cartron G, Seymour JF, et al. Clinical outcome of patients with follicular lymphoma receiving chemoimmunotherapy in the PRIMA study is not affected by FCGR3A and FCGR2A polymorphisms. Blood 2012;120:2650–2657.
   PubMed Web of Science ®Google Scholar
• Bowles JA, Wang SY, Link BK, et al. Anti-CD20 monoclonal antibody with enhanced affinity for CD16 activates NK cells at lower concentrations and more effectively than rituximab. Blood 2006;108:2648–2654.
   PubMed Web of Science ®Google Scholar
• Forero-Torres A, de Vos S, Pohlman BL, et al. Results of a phase 1 study of AME-133v (LY2469298), an Fc-engineered humanized mono-clonal anti-CD20 antibody, in FcγRIIIa-genotyped patients with previously treated follicular lymphoma. Clin Cancer Res 2012;18: 1395–1403.
   PubMed Web of Science ®Google Scholar
• Cheson BD, Horning SJ, Coiffier B, 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.
   PubMed Web of Science ®Google Scholar
• McLaughlin P, Grillo-López AJ, Link BK, et al. Rituximab chimeric anti-CD20 monoclonal antibody therapy for relapsed indolent lymphoma: half of patients respond to a four-dose treatment program. J Clin Oncol 1998;16:2825–2833.
   PubMed Web of Science ®Google Scholar
• Davis TA, Grillo-López AJ, White CA, et al. Rituximab anti-CD20 monoclonal antibody therapy in non-Hodgkin's lymphoma: safety and efficacy of re-treatment. J Clin Oncol 2000;18:3135–3143.
   PubMed Web of Science ®Google Scholar
• Solal-Céligny P, Roy P, Colombat P, et al. Follicular lymphoma international prognostic index. Blood 2004;104:1258–1265.
   PubMed Web of Science ®Google Scholar
• Brice P, Bastion Y, Lepage E, et al. Comparison in low-tumor-burden follicular lymphomas between an initial no-treatment policy, prednimustine, or interferon alfa: a randomized study from the Groupe d’Etude des Lymphomes Folliculaires. Groupe d’Etude des Lymphomes de l’Adulte. J Clin Oncol 1997;15: 1110–1117.
   PubMed Web of Science ®Google Scholar
• Vidal L, Gafter-Gvili A, Leibovici L, 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;101:248–255.
   PubMed Web of Science ®Google Scholar
• Marcus R, Imrie K, Solal-Celigny P, 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;26:4579–4586.
   PubMed Web of Science ®Google Scholar
• 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; 21:3940–3947.
   PubMed Web of Science ®Google Scholar
• Ghielmini M, Rufibach K, Salles G, 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;16:1675–1682.
   PubMed Web of Science ®Google Scholar
• Persky DO, Dornan D, Goldman BH, et al. Fc gamma receptor 3a genotype predicts overall survival in follicular lymphoma patients treated on SWOG trials with combined monoclonal antibody plus chemotherapy but not chemotherapy alone. Haematologica 2012;97:937–942.
   PubMed Web of Science ®Google Scholar
• Lim SH, Beers SA, French RR, et al. Anti-CD20 monoclonal antibodies: historical and future perspectives. Haematologica 2010;95:135–143.
   PubMed Web of Science ®Google Scholar
• Berinstein NL, Grillo-López AJ, White CA, et al. Association of serum rituximab (IDEC-C2B8) concentration and anti-tumor response in the treatment of recurrent low-grade or follicular non-Hodgkin's lymphoma. Ann Oncol 1998;9:995–1001.
   PubMed Web of Science ®Google Scholar
• Regazzi MB, Iacona I, Avanzini MA, et al. Pharmacokinetic behavior of rituximab:a study of different schedules of administration for heterogeneous clinical settings. Ther Drug Monit 2005;27: 785–792.
   PubMed Web of Science ®Google Scholar
• Igarashi T, Ohtsu T, Fujii H, et al. Re-treatment of relapsed indolent B-cell lymphoma with rituximab. Int J Hematol 2001;73: 213–221.
   PubMed Web of Science ®Google Scholar