Seattle submits supplemental BLA to FDA for Phase III Aethera trial of Adcetris in HL patients

Published 19 February 2015

Seattle Genetics has submitted a supplemental biologics license application (BLA) to the US Food and Drug Administration (FDA) based on data from Phase III Aethera trial of Adcetris (Brentuximab Vedotin) in post-transplant hodgkin lymphoma (HL) patients at high risk of relapse.

Adcetris is an antibody-drug conjugate (ADC) directed to CD30, which is expressed in classical HL and systemic anaplastic large cell lymphoma (sALCL).

The Phase III trial of Adcetris was carried out as consolidation therapy immediately following an autologous stem cell transplant (ASCT) in HL patients.

The trial, which included 329 HL patients, achieved its primary endpoint and showed a significant increase in progression-free survival (PFS) per independent review facility, with a hazard ratio of 0.57 and a p-value of 0.001.

Seattle Genetics president and chief executive officer Clay Siegall said: "With approximately half of all Hodgkin lymphoma patients who undergo an autologous stem cell transplant experiencing disease relapse, there is a significant need to identify regimens that extend progression-free survival.

"Results from the Aethera trial demonstrated that treating high risk Hodgkin lymphoma patients with Adcetris in following autologous stem cell transplant resulted in a statistically significant improvement in progression-free survival with a manageable safety profile."

The company said that median PFS was 43 months for patients who received Adcetris versus 24 months for patients who received placebo.

The two-year PFS rate was 63% in the Adcetris arm compared to 51% in the placebo arm.

Currently, Adcetris is approved in relapsed HL and sALCL but is not approved for consolidation therapy in HL patients immediately after ASCT.

Link:
Seattle submits supplemental BLA to FDA for Phase III Aethera trial of Adcetris in HL patients