Clinical efficacy of zanolimumab (HuMax-CD4): two phase 2 studies in refractory cutaneous T-cell lymphoma.
Authors
Kim, Youn HDuvic, Madeleine
Obitz, Erik
Gniadecki, Robert
Iversen, Lars
Osterborg, Anders
Whittaker, Sean
Illidge, Timothy M
Schwarz, Thomas
Kaufmann, Roland
Cooper, Kevin
Knudsen, Kim M
Lisby, Steen
Baadsgaard, Ole
Knox, Susan J
Affiliation
Multidisciplinary Cutaneous Lymphoma Program, Stanford Comprehensive Cancer Center, 875 Blake Wilbur Drive, Stanford, CA 94305, USA. younkim@stanford.eduIssue Date
2007-06-01
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The efficacy and safety of zanolimumab in patients with refractory cutaneous T-cell lymphoma (CTCL) have been assessed in two phase 2, multicenter, prospective, open-label, uncontrolled clinical studies. Patients with treatment refractory CD4(+) CTCL (mycosis fungoides [MF], n = 38; Sézary syndrome [SS], n = 9) received 17 weekly infusions of zanolimumab (early-stage patients, 280 and 560 mg; advanced-stage patients, 280 and 980 mg). The primary end point was objective response (OR) as assessed by composite assessment of index lesion disease activity score. Secondary end points included physician's global assessment (PGA), time to response, response duration, and time to progression. ORs were recorded for patients in both CTCL types (MF, 13 ORs; SS, 2 ORs). In the high-dose groups (560 and 980 mg dose groups), a response rate of 56% was obtained with a median response of 81 weeks. Adverse events reported most frequently included low-grade infections and eczematous dermatitis. Zanolimumab showed marked clinical efficacy in the treatment of patients with refractory MF, with early onset of response, high response rate, and durable responses. The treatment was well tolerated with no dose-related toxicity other than the targeted depletion of peripheral T cells. A pivotal study has been initiated based on these findings.Citation
Clinical efficacy of zanolimumab (HuMax-CD4): two phase 2 studies in refractory cutaneous T-cell lymphoma. 2007, 109 (11):4655-62 BloodJournal
BloodDOI
10.1182/blood-2006-12-062877PubMed ID
17311990Type
ArticleLanguage
enISSN
0006-4971ae974a485f413a2113503eed53cd6c53
10.1182/blood-2006-12-062877
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