Results of a phase I/II study of ocrelizumab, a fully humanized anti-CD20 mAb, in patients with relapsed/refractory follicular lymphoma
(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)
Please use this url to cite or link to this publication:
https://lup.lub.lu.se/record/1673480
- author
- organization
- publishing date
- 2010
- 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}}, }