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news.Seattle Genetics and Takeda Pharmaceutical Company have announced that patients with Hodgkin lymphoma (HL) who received ADCETRIS (brentuximab vedotin) as consolidation therapy immediately following an autologous stem cell transplantation (ASCT) lived significantly longer without disease progression compared to patients who received placebo.
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The phase 3 clinical trial, 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 (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 (sALCL). ADCETRIS is not approved in the AETHERA treatment setting.
The AETHERA trial met its primary endpoint with ADCETRIS treatment resulting in a statistically significant improvement in progression-free survival (PFS) versus placebo as assessed by an independent central review committee (hazard ratio=0.57; p-value=0.001), which equates to a 75 percent improvement in PFS.
PFS was assessed after a minimum of two years post initiation of treatment for all study patients. A pre-specified interim analysis of overall survival showed no statistically significant difference between the treatment arms. Patients on both study arms with progression of HL received a variety of subsequent therapies.
Notably, most patients on the placebo arm received ADCETRIS after progression. A further analysis of overall survival is planned in 2016. The safety profile of ADCETRIS in the AETHERA trial was generally consistent with the existing prescribing information.
An abstract was previously submitted for data presentation at the American Society of Hematology (ASH) annual meeting, December 6-9, 2014, in San Francisco, CA.
"Patients with Hodgkin lymphoma who relapse or are refractory to frontline therapy represent a significant unmet medical need. We believe the positive top-line results of the AETHERA trial demonstrate the ability of ADCETRIS to consolidate remissions and extend progression-free survival in patients with Hodgkin lymphoma who are at risk of relapse following an autologous transplant while having an acceptable safety profile," said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics.
"We anticipate reporting more complete AETHERA data at the ASH annual meeting in December and intend to submit a supplemental Biologics License Application to the FDA in 2015 for approval in this setting."
"The AETHERA clinical trial results may support a new treatment paradigm for certain patients with Hodgkin lymphoma post autologous stem cell transplant," said Michael Vasconcelles, M.D., Global Head, Oncology Therapeutic Area Unit, Takeda Pharmaceutical Company.
"As the first randomized clinical trial of a comprehensive clinical development program with ADCETRIS, these data also provide important information to inform the entire ADCETRIS program. For these reasons, we are particularly grateful to the patients, in partnership with their families and the study investigators, for their participation in AETHERA. We look forward to submitting these data to regulatory agencies in our territories."