Abstract:
: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.
journal_name
Bloodjournal_title
Bloodauthors
Kim YH,Duvic M,Obitz E,Gniadecki R,Iversen L,Osterborg A,Whittaker S,Illidge TM,Schwarz T,Kaufmann R,Cooper K,Knudsen KM,Lisby S,Baadsgaard O,Knox SJdoi
10.1182/blood-2006-12-062877subject
Has Abstractpub_date
2007-06-01 00:00:00pages
4655-62issue
11eissn
0006-4971issn
1528-0020pii
blood-2006-12-062877journal_volume
109pub_type
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