Supplemental BLA Filed for Use of Adcetris in Peripheral T-Cell Lymphoma

Seattle Genetics has submitted a supplemental Biologics License Application (BLA) to the FDA for brentuximab vedotin (Adcetris) for use in combination with chemotherapy for patients with CD30-expressing peripheral T-cell lymphoma (PTCL), according to a press release.
The BLA submission is based on data from the phase 3 ECHELON-2 trial. According to Seattle Genetics, brentuximab vedotin is an antibody-drug conjugate directed to CD30, which is expressed on the surface of several types of PTCL.
Brentuximab vedotin is not currently approved for the frontline treatment of PTCL.
The clinical study evaluated brentuximab vedotin plus cyclophosphamide, doxorubicin, and prednisone (CHP) compared with a recognized standard of care chemotherapy regimen cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) in previously untreated CD30-expressing PTCL. The trial included 450 patients, approximately 75% of whom were diagnosed with systemic anaplastic large cell lymphoma (sALCL).
Based on the data, the combination significantly improved progression-free survival (PFS). Compared with CHOP, the brentuximab vedotin plus CHP demonstrated superior overall survival (hazard ratio=0.66; p-value=0.0244), according to the study.
“CD30 is expressed in several subtypes of peripheral T-cell lymphoma, an aggressive type of non-Hodgkin lymphoma, and the current standard of care for frontline treatment consisting of multi-agent chemotherapy regimen called CHOP has not changed in several decades,” Clay Siegall, PhD, president and chief executive officer of Seattle Genetics, said in a statement. “Results from the ECHELON-2 trial demonstrated a statistically significant and clinically meaningful improvement in progression-free survival and importantly, overall survival, in patients with previously untreated CD30-expressing PTCL who were treated with Adcetris in combination with CHP chemotherapy over standard of care CHOP chemotherapy.”
Key secondary endpoints, including PFS in patients with sALCL, complete remission rate, and objective response rate were also statistically significant. Additionally, the safety profile of brentuximab vedotin plus CHP in the trial was comparable to CHOP and consistent with the established safety profile of brentuximab vedotin in combination with chemotherapy.
The full results will be presented at the upcoming American Society of Hematology Annual Meeting in December, according to the release.
Seattle Genetics Submits Supplemental Biologics License Application for ADCETRIS® (Brentuximab Vedotin) in Frontline Treatment of CD30-Expressing Peripheral T-Cell Lymphoma [news release]. Accessed November 5, 2018.

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