29.09.2014 12:53:33
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Seattle Genetics, Takeda Report Positive Data From Phase 3 Trial Of ADCETRIS
(RTTNews) - Seattle Genetics, Inc. (SGEN) and Takeda Pharmaceutical Company Ltd. (TKPYY.PK) announced that patients with Hodgkin lymphoma or HL who received ADCETRIS as consolidation therapy immediately following an autologous stem cell transplantation or ASCT lived significantly longer without disease progression compared to patients who received placebo. The phase 3 study, known as AETHERA, compared the use of single agent ADCETRIS to placebo in 329 patients with HL who were at risk of relapse.
ADCETRIS is an antibody-drug conjugate or ADC directed to CD30, a defining marker of classical HL. ADCETRIS has been approved in more than 45 countries for the treatment of relapsed HL and systemic anaplastic large cell lymphoma or sALCL. ADCETRIS is not approved in the AETHERA treatment setting.
The AETHERA trial achieved its primary endpoint with ADCETRIS treatment resulting in a statistically significant improvement in progression-free survival or PFS, versus placebo as assessed by an independent central review committee, which equates to a 75 percent improvement in PFS.
The AETHERA study is a randomized, double-blind, placebo-controlled phase 3 study designed to evaluate the potential of ADCETRIS to extend PFS post-ASCT in patients with HL who have at least one risk factor for progression.
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