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Results of a phase I/II study of ocrelizumab, a fully humanized anti-CD20 mAb, in patients with relapsed/refractory follicular lymphoma

Morschhauser, F.; Marlton, P.; Vitolo, U.; Lindén, Ola LU ; Seymour, J. F.; Crump, M.; Coiffier, B.; Foa, R.; Wassner, E. and Burger, H. -U., et al. (2010) In Annals of Oncology 21(9). p.1870-1876
Abstract
Background: Ocrelizumab is a humanized anti-CD20 antibody with increased antibody-dependent cellular cytotoxicity compared with rituximab. This phase I/II study evaluated its safety and efficacy in patients with relapsed/refractory follicular lymphoma (FL) after prior rituximab therapy. Design and methods: Forty-seven patients were treated in three dose cohorts and received eight infusions every 3 weeks: cohort A, 200 mg/m(2) (n = 15); cohort B, 375 mg/m(2) (n = 16); cohort C, first dose 375 mg/m(2), seven subsequent doses of 750 mg/m(2) (n = 16). Patients were assessed for safety, efficacy, pharmacodynamics and pharmacokinetics. Results: The median patient age was 58 years, the majority had Ann Arbor stage III/IV disease and had received... (More)
Background: Ocrelizumab is a humanized anti-CD20 antibody with increased antibody-dependent cellular cytotoxicity compared with rituximab. This phase I/II study evaluated its safety and efficacy in patients with relapsed/refractory follicular lymphoma (FL) after prior rituximab therapy. Design and methods: Forty-seven patients were treated in three dose cohorts and received eight infusions every 3 weeks: cohort A, 200 mg/m(2) (n = 15); cohort B, 375 mg/m(2) (n = 16); cohort C, first dose 375 mg/m(2), seven subsequent doses of 750 mg/m(2) (n = 16). Patients were assessed for safety, efficacy, pharmacodynamics and pharmacokinetics. Results: The median patient age was 58 years, the majority had Ann Arbor stage III/IV disease and had received a median of 2 (range 1-6) prior regimens. Ocrelizumab was well tolerated with grade 3/4 toxicity occurring in 9% of patients. The most common toxicity was infusion-related reactions (74% patients), all grade 1/2 except one grade 3 event. The objective response rate was 38% and was similar in patients with low-affinity and high-affinity variants of the Fc gamma receptor IIIa (Fc gamma RIIIa). With follow-up of similar to 28 months, the median progression-free survival was 11.4 months. Conclusion: Ocrelizumab demonstrated activity in patients with relapsed/refractory FL following prior rituximab treatment, with safety similar to rituximab although adverse events appeared milder. (Less)
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published
subject
keywords
ocrelizumab, follicular lymphoma, CDC, ADCC, anti-CD20 antibody
in
Annals of Oncology
volume
21
issue
9
pages
1870 - 1876
publisher
Oxford University Press
external identifiers
  • wos:000281324500020
  • scopus:77955175014
ISSN
1569-8041
DOI
10.1093/annonc/mdq027
language
English
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yes
id
7b458f09-e403-478d-8a11-3f44ead889cc (old id 1673480)
date added to LUP
2010-09-23 10:53:16
date last changed
2018-05-29 10:17:18
@article{7b458f09-e403-478d-8a11-3f44ead889cc,
  abstract     = {Background: Ocrelizumab is a humanized anti-CD20 antibody with increased antibody-dependent cellular cytotoxicity compared with rituximab. This phase I/II study evaluated its safety and efficacy in patients with relapsed/refractory follicular lymphoma (FL) after prior rituximab therapy. Design and methods: Forty-seven patients were treated in three dose cohorts and received eight infusions every 3 weeks: cohort A, 200 mg/m(2) (n = 15); cohort B, 375 mg/m(2) (n = 16); cohort C, first dose 375 mg/m(2), seven subsequent doses of 750 mg/m(2) (n = 16). Patients were assessed for safety, efficacy, pharmacodynamics and pharmacokinetics. Results: The median patient age was 58 years, the majority had Ann Arbor stage III/IV disease and had received a median of 2 (range 1-6) prior regimens. Ocrelizumab was well tolerated with grade 3/4 toxicity occurring in 9% of patients. The most common toxicity was infusion-related reactions (74% patients), all grade 1/2 except one grade 3 event. The objective response rate was 38% and was similar in patients with low-affinity and high-affinity variants of the Fc gamma receptor IIIa (Fc gamma RIIIa). With follow-up of similar to 28 months, the median progression-free survival was 11.4 months. Conclusion: Ocrelizumab demonstrated activity in patients with relapsed/refractory FL following prior rituximab treatment, with safety similar to rituximab although adverse events appeared milder.},
  author       = {Morschhauser, F. and Marlton, P. and Vitolo, U. and Lindén, Ola and Seymour, J. F. and Crump, M. and Coiffier, B. and Foa, R. and Wassner, E. and Burger, H. -U. and Brennan, B. and Mendila, M.},
  issn         = {1569-8041},
  keyword      = {ocrelizumab,follicular lymphoma,CDC,ADCC,anti-CD20 antibody},
  language     = {eng},
  number       = {9},
  pages        = {1870--1876},
  publisher    = {Oxford University Press},
  series       = {Annals of Oncology},
  title        = {Results of a phase I/II study of ocrelizumab, a fully humanized anti-CD20 mAb, in patients with relapsed/refractory follicular lymphoma},
  url          = {http://dx.doi.org/10.1093/annonc/mdq027},
  volume       = {21},
  year         = {2010},
}