Trial of Brentuximab Vedotin in CD30+ CTCL Meets Primary End Point
The phase 3 ALCANZA study evaluating brentuximab vedotin (Adcetris) met its primary endpoint.
The phase 3 ALCANZA study evaluating brentuximab vedotin (Adcetris) met its primary endpoint, demonstrating a significant improvement in the rate of objective response lasting at least 4 months, for patients with CD30-expressing cutaneous T-cell lymphoma (CTCL).1
Investigators enrolled 131 patients who received prior systemic or radiation therapy. Participants were randomly assigned to receive single-agent brentuximab vedotin or investigator's choice of standard therapies, such as methotrexate and bexarotene.
The rate of objective response lasting at least 4 months was 56.3% in the brentuximab vedotin arm, compared with 12.5% in the comparator arm (P < .0001). The complete response rate, progression-free survival, and reduction in the burden of symptoms during treatment were better in the brentuximab vedotin arm.
Adverse events were consistent with previously reported data.
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An abstract of the ALCANZA trial will be submitted for data presentation at the 58th American Society of Hematology (ASH) Annual Meeting and Exposition in San Diego, CA.
- Takeda and Seattle Genetics announce positive data from phase 3 ALCANZA clinical trial of Adcetris (brentuximab vedotin) for CD30-expressing cutaneous T-cell lymphoma. Seattle Genetics website. http://investor.seattlegenetics.com/phoenix.zhtml?c=124860&p=irol-newsArticle&ID=2191428. Updated August 1, 2016. Accessed August 24, 2016.