Seattle Genetics, Inc., Takeda Pharmaceutical Co. Ltd. ADCETRIS Phase 3 Demonstrated Statistically Significant Improvement In Progression-Free Survival
Published: Dec 10, 2014
December 9, 2014
By Krystle Vermes, BioSpace.com Breaking News Staff
Seattle Genetics, Inc. and Takeda Pharmaceutical Co. Ltd. released the results of their Phase 3 AETHERA clinical trial at the American Society of Hematology annual meeting. The trial showed that Adcetris, also known as brentuximab vedotin, provided a significant improvement in progression-free survival compared to patients who received the placebo.
“Over the past 20 years, no improvement has been shown in the outcomes of patients treated with autologous stem cell transplant regimens for aggressive lymphomas, including Hodgkin lymphoma,” said Craig Moskowitz, clinical director at the Division of Hematologic Oncology at the Memorial Sloan Kettering Cancer Center. “Approximately half of the patients who undergo an autologous stem cell transplant will relapse, demonstrating a significant need to identify regimens that improve patient outcomes. Data from the AETHERA clinical trial demonstrate that the addition of brentuximab vedotin use in the immediate post-transplant setting resulted in a statistically significant improvement in PFS with a manageable safety profile.”
Adcetris is an antibody-drug conjugate that is directed toward CD30, a marketer of classical Hodgkin lymphoma. The drug was examined in patients with HL at risk of relapse following an autologous stem cell transplant.
“The outcome of the AETHERA trial is an important milestone. It demonstrates that early consolidation treatment with Adcetris in Hodgkin lymphoma patients at risk of relapse following an autologous transplant can result in a substantial improvement in PFS versus placebo,” said Clay Siegall, president and chief executive officer of Seattle Genetics. “We are pleased to share these data with the physician community at ASH. We will be meeting with the FDA soon to discuss the submission of a supplemental Biologics License Application in the first half of 2015 seeking approval in this consolidation setting.”
AETHERA was a randomized, double-blind, placebo-controlled Phase 3 study. Its primary endpoint was progression-free survival, while its secondary endpoints included overall survival, safety and tolerability. A total of 329 patients were enrolled in the study.
“The AETHERA data provide compelling evidence regarding the potential utility of Adcetris as consolidation therapy post-transplant in these Hodgkin lymphoma patients, and we look forward to submitting these data to health authorities around the world,” said Michael Vasconcelles, global head of the Oncology Therapeutic Area Unit at Takeda Pharmaceutical Company Limited. “Going forward, we are conducting a robust clinical development program to more fully understand the potential of CD30 targeting with Adcetris in frontline disease through our ongoing Phase 3 ECHELON-1 and ECHELON-2 trials in HL and mature T-cell lymphomas.”