publication date: Sep. 22, 2016
Lymphoma Adcetris Improves ORR4 in Phase III Trial
Takeda Pharmaceutical Co. Ltd. and Seattle Genetics Inc. said that the phase III ALCANZA clinical trial evaluating Adcetris (brentuximab vedotin) in cutaneous T-cell lymphoma met its primary endpoint, demonstrating a highly statistically significant improvement in the rate of objective response lasting at least four months (ORR4).
This randomized trial, which received a Special Protocol Assessment from FDA and scientific advice from the European Medicines Agency, compared the use of single-agent Adcetris to a control arm of investigator’s choice of standard therapies, methotrexate or bexarotene, in 131 patients with CD30-expressing CTCL who received prior systemic or radiation therapy.
Adcetris is an antibody-drug conjugate directed to CD30 which is expressed on skin lesions in approximately 50 percent of patients with CTCL. Adcetris is currently not approved for the treatment of CTCL.
The results of the ALCANZA trial demonstrated that treatment with Adcetris resulted in a highly statistically significant improvement in the ORR4 versus the control arm as assessed by an independent review committee (p-value <0.0001). The ORR4 was 56.3 percent in the Adcetris arm compared to 12.5 percent in the control arm. The key secondary endpoints specified in the protocol, including complete response rate, progression-free survival and reduction in the burden of symptoms during treatment, were all highly statistically significant in favor of the Adcetris arm. The … Continue reading CCL 39-08 Adcetris Improves ORR4 in Phase III Trial
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