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., Linden, O., Seymour, J. F., Crump, M., Coiffier, B., Foa, R., Wassner, E., Burger, H.-U., Brennan, B. and Mendila, M. (2010) Results of a phase I/II study of ocrelizumab, a fully humanized anti-CD20 mAb, in patients with relapsed/refractory follicular lymphoma. Annals of Oncology, 21 9: 1870-1876. doi:10.1093/annonc/mdq027


Author Morschhauser, F.
Marlton, P.
Vitolo, U.
Linden, O.
Seymour, J. F.
Crump, M.
Coiffier, B.
Foa, R.
Wassner, E.
Burger, H.-U.
Brennan, B.
Mendila, M.
Title Results of a phase I/II study of ocrelizumab, a fully humanized anti-CD20 mAb, in patients with relapsed/refractory follicular lymphoma
Journal name Annals of Oncology   Check publisher's open access policy
ISSN 0923-7534
1569-8041
Publication date 2010-02-15
Sub-type Article (original research)
DOI 10.1093/annonc/mdq027
Open Access Status
Volume 21
Issue 9
Start page 1870
End page 1876
Total pages 7
Place of publication Oxford, United Kingdom
Publisher Oxford University Press
Collection year 2011
Language eng
Subject C1
920102 Cancer and Related Disorders
1112 Oncology and Carcinogenesis
Formatted 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/m2 (n = 15); cohort B, 375 mg/m2 (n = 16); cohort C, first dose 375 mg/m2, seven subsequent doses of 750 mg/m2 (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 Fcγ receptor IIIa (FcγRIIIa). With follow-up of ∼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.
Copyright © 2011 European Society for Medical Oncology
Keyword ADCC
Anti-CD20 antibody
CDC
Follicular lymphoma
Ocrelizumab
Q-Index Code C1
Q-Index Status Confirmed Code
Institutional Status Non-UQ

Document type: Journal Article
Sub-type: Article (original research)
Collections: Non HERDC
School of Medicine Publications
 
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Created: Wed, 14 Apr 2010, 16:32:42 EST by Maree Knight on behalf of Medicine - Princess Alexandra Hospital