Seattle Genetics receives FDA Breakthrough Therapy Designation for Adcetris (brentuximab vedotin) in frontline advanced Hodgkin lymphoma.
Seattle Genetics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to Adcetris (brentuximab vedotin) in combination with chemotherapy for the frontline treatment of patients with advanced classical Hodgkin lymphoma.
The positive topline results of the phase 3 ECHELON-1 clinical trial were announced in June 2017 and full data will be presented at the upcoming American Society of Hematology (ASH) annual meeting, December 9-12, 2017 in Atlanta, Georgia.
Adcetris is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of classical Hodgkin lymphoma. Adcetris is being evaluated globally as the foundation of care for CD30-expressing lymphomas in more than 70 corporate- and investigator-sponsored clinical trials. Adcetris is currently not approved as a frontline therapy for Hodgkin lymphoma.
The FDA’s Breakthrough Therapy Designation is intended to expedite the development and review of promising drug candidates for serious or life-threatening conditions. It is based upon clinical evidence of substantial improvement over existing therapies on one or more clinically significant endpoints.
“The phase 3 ECHELON-1 study that supports the Breakthrough Therapy Designation for Adcetris in combination with chemotherapy showed superior activity versus the standard of care chemotherapy regimen in the treatment of frontline advanced classical Hodgkin lymphoma patients,” said Clay Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. “The decision by the FDA to grant this designation recognizes the need for new options that can change the care of people with newly diagnosed advanced Hodgkin lymphoma. The designation supports our goal to make Adcetris available to patients in this setting as soon as possible. We look forward to presenting the data from our phase 3 ECHELON-1 trial at the upcoming ASH annual meeting and intend to submit a supplemental Biologics License Application to the FDA before the end of 2017.”
This Breakthrough Therapy Designation was based on data from the phase 3 ECHELON-1 clinical trial. The ECHELON-1 study evaluated a combination of Adcetris plus AVD (Adriamycin, vinblastine, dacarbazine) compared to a recognized standard of care chemotherapy regimen in previously untreated advanced classical Hodgkin lymphoma.
The ECHELON-1 study met its primary endpoint of a statistically significant improvement in modified progression-free survival (PFS) of the Adcetris containing regimen versus the control arm as assessed by an Independent Review Facility (hazard ratio=0.770; p-value=0.035). The two-year modified PFS rate for patients in the Adcetris arm was 82.1 percent compared to 77.2 percent in the control arm.
Interim analysis of overall survival, the key secondary endpoint, also trended in favor of the Adcetris plus AVD arm. The safety profile of Adcetris+AVD in the ECHELON-1 trial was consistent with that known for the single-agent components of the regimen.
(Source: Business Wire)