SAN DIEGO – Treatment with brentuximab vedotin is associated with superior clinical outcomes compared with standard of care options, such as methotrexate and bexarotene, in patients with CD30-expressing cutaneous T cell lymphoma (CTCL), according to a study presented at the American Society of Hematology (ASH) 58th Annual Meeting and Exposition.1
Current systemic therapies for CTCL rarely provide reliable and/or durable responses.
“Brentuximab vedotin, a CD30-targeting antibody-drug conjugate, has shown significant clinical activity with an acceptable safety profile in CTCL in 2 phase 2 trials,” said Youn H. Kim, MD, principal investigator and medical oncologist at the Stanford University School of Medicine, California. “These findings support the rationale for ALCANZA, a randomized phase 3 trial of the efficacy and safety of brentuximab vedotin vs physician’s choice of methotrexate or bexarotene in previously treated patients with CD30-expressing CTCL.”
For the multicenter, open-label ALCANZA study (ClinicalTrials.gov Identifier: NCT01578499), researchers enrolled 128 patients with CD30-expressing mycosis fungoides who received at least 1 prior systemic therapy or primary cutaneous anaplastic large cell lymphoma (pcALCL) who received at least 1 prior systemic therapy or radiotherapy.
Participants were randomly assigned 1:1 to receive brentuximab vedotin intravenously every 4 weeks or physician’s choice of either methotrexate or bexarotene. Patients were treated until disease progression or unacceptable toxicity.
At a median follow-up of 17.5 months, 56.3% of patients who received brentuximab vedotin achieved an objective response lasting 4 months or longer, the primary outcome measure, compared with 12.5% of patients assigned to chemotherapy (P < .0001). Ten patients in the brentuximab vedotin arm and 1 in the chemotherapy achieved complete responses (P = .0046).
Brentuximab vedotin reduced the risk of progression or death by 73% vs chemotherapy (hazard ratio, 0.270; 95% CI, 0.169-0.430; P < .0001); median progression-free survival was 16.7 months and 3.5 months, respectively.
Brentuximab vedotin therapy was also associated with significantly greater symptom reduction (P < .0001).
Safety data for brentuximab vedotin were consistent with the established tolerability profile, in particular with respect to peripheral neuropathy. Nearly a quarter (24%) of patients in the brentuximab vedotin group discontinued treatment due to adverse events, vs 8% of those given chemotherapy; 41% and 47% experienced grade 3 or worse adverse events, respectively.
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“Brentuximab vedotin showed superior primary and secondary efficacy outcomes over physician’s choice of either bexarotene or methotrexate in mycosis fungoides and pcALCL,” concluded Dr Kim. “These compelling results have potential practice-changing implications for the use of brentuximab vedotin in managing CD30-expressing CTCL in patients who require systemic therapy.”
- Kim YH, Whittaker S, Horwitz SM, et al. Brentuximab vedotin demonstrates significantly superior clinical outcomes in patients with CD30-expressing cutaneous T cell lymphoma versus physician’s choice (methotrexate or bexarotene): The hase 3 ALCANZA study. Paper presented at: American Society of Hematology (ASH) 58th Annual Meeting and Exposition; December 3-6, 2016; San Diego, CA.