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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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organization
publishing date
type
Contribution to journal
publication status
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
  • pmid:20157180
ISSN
1569-8041
DOI
10.1093/annonc/mdq027
language
English
LU publication?
yes
id
7b458f09-e403-478d-8a11-3f44ead889cc (old id 1673480)
date added to LUP
2016-04-01 12:54:25
date last changed
2022-02-26 18:11:16
@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}},
  keywords     = {{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}},
  doi          = {{10.1093/annonc/mdq027}},
  volume       = {{21}},
  year         = {{2010}},
}