Adcetris as Consolidation Therapy After Stem Cell Transplant in HL

Seattle Genetics, along with partner Takeda Pharmaceutical Company Ltd., is announcing positive top-line data from the randomized phase III AETHERA study on Adcetris as consolidation therapy following an autologous stem cell transplantation (ASCT) in patients with Hodgkin lymphoma.

Consolidation therapy targets cancer cells that may remain after initial treatment.

The phase III AETHERA study compared single-agent Adcetris to placebo in 329 Hodgkin lymphoma patients at high risk of relapse. The primary 'endpoint' (something that can be objectively measured) of the study was progression-free survival (PFS).

According to the results, compared to placebo patients given Adcetris in the consolidation setting had a 75 percent improvement in PFS. Seattle Genetics administered Adcetris to those patients in the placebo arm of the study when their disease showed progression.

The company will consider this trial from the endpoint of overall survival in 2016, but before then they will present detailed versions of this data at the annual meeting of the American Society of Hematology (ASH) in December 2014. They will likely submit a supplemental biologics license application (BLA) to the FDA for Adcetris for this indication in 2015.

Adcetris is also being evaluated in three other phase III studies: ALCANZA (relapsed cutaneous T-cell lymphoma (CTCL); ECHELON-1 (front-line advanced classical Hodgkin lymphoma) and ECHELON-2 (front-line CD30-positive MTCL, including systemic anaplastic large cell lymphoma (sALCL).

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