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Seattle Genetics, Takeda: Positive ADCETRIS Data From Phase 3 ECHELON-2 Trial

Seattle Genetics, Inc. (SGEN) and Japan's Takeda Pharmaceutical Company Limited announced late Monday positive data from the ECHELON-2 phase 3 clinical trial for ADCETRIS (Brentuximab Vedotin) in frontline treatment of CD30-Expressing Peripheral T-Cell Lymphomas.

The data demonstrated that frontline treatment with ADCETRIS (brentuximab vedotin) in combination with CHP (cyclophosphamide, doxorubicin, prednisone) is effective in extending progression-free survival and overall survival with a safety profile comparable to CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone), a current standard of care in patients with CD30-expressing peripheral T-cell lymphomas or PTCL.

ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, which is expressed on the surface of several types of PTCL.

The data was presented in an oral session at the 60th American Society of Hematology (ASH) Annual Meeting. These data were also simultaneously published online in TheLancet.

The positive topline results of the ECHELON-2 phase 3 clinical trial were previously reported in October 2018. In November 2018, ADCETRIS was approved by the U.S. Food and Drug Administration for adults with previously untreated systemic anaplastic large cell lymphoma or sALCL or other CD30-expressing PTCL, including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with CHP.

The ECHELON-2 data were the basis of a supplemental Biologics License Application or BLA, which was reviewed by the FDA under its Real-Time Oncology Review Pilot Program and approved less than two weeks after complete submission of the supplemental BLA.

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