Brentuximab Vedotin Granted FDA Breakthrough Therapy Designation in Front-Line Advanced Hodgkin Lymphoma
On October 2, Seattle Genetics, Inc, announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to brentuximab vedotin (Adcetris) in combination with chemotherapy for the front-line treatment of patients with advanced classical Hodgkin lymphoma. The positive topline results of the phase III ECHELON-1 clinical trial were announced in June 2017, and full data will be presented at the upcoming 2017 American Society of Hematology Annual Meeting.
Brentuximab vedotin is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of classical 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 on clinical evidence of substantial improvement over existing therapies on one or more clinically significant endpoints.
“The phase III ECHELON-1 study that supports the Breakthrough Therapy designation for brentuximab vedotin in combination with chemotherapy showed superior activity vs the standard-of-care chemotherapy regimen in the treatment of front-line advanced classical Hodgkin lymphoma patients,” said Clay Siegall, PhD, 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.”
ECHELON-1
The ECHELON-1 study evaluated a combination of brentuximab vedotin plus AVD (doxorubicin, vinblastine, dacarbazine) compared to a recognized standard-of-care chemotherapy regimen in previously untreated advanced classical Hodgkin lymphoma.
The study met its primary endpoint of a statistically significant improvement in modified progression-free survival of the brentuximab vedotin–containing regimen vs the control arm, as assessed by an Independent Review Facility (hazard ratio = 0.770; P = .035). The 2-year modified progression-free survival rate for patients in the brentuximab vedotin arm was 82.1%, compared to 77.2% in the control arm. Interim analysis of overall survival—the key secondary endpoint—also trended in favor of the brentuximab vedotin–plus-AVD arm. The safety profile of brentuximab vedotin plus AVD in the ECHELON-1 trial was consistent with that known for the single-agent components of the regimen.
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