Seattle Genetics, Inc. (Nasdaq: SGEN) today highlighted several anticipated 2014 milestones related to ADCETRIS (brentuximab vedotin) and its antibody-drug conjugate (ADC) pipeline programs in a presentation at the 32 nd J.P. Morgan Healthcare Conference on Monday, January 13, 2014 at 9:30 a.m. Pacific Time. Highlights include:
- The company announced that it has aligned with collaborator Takeda Pharmaceutical Company Limited (Takeda), as well as with the U.S. Food and Drug Administration (FDA) and European Union regulators, on a protocol amendment to unblind the phase 3 AETHERA clinical trial in the second half of 2014.
- Under the collaboration with Takeda, ADCETRIS recently received marketing authorization in Australia and Singapore, and regulatory approvals are being pursued in multiple other countries globally during 2014, including Japan.
- ADCETRIS was recently added to the National Comprehensive Cancer Network (NCCN) guidelines for the treatment of relapsed CD30-positive peripheral T-cell lymphoma (PTCL).
- Seattle Genetics reviewed anticipated 2014 data presentations and program milestones from its portfolio of ADC programs, including a broad clinical development program evaluating ADCETRIS for the treatment of CD30-positive malignancies and progress with ADC candidates SGN-CD19A, SGN-CD33A and SGN-CD70A.
“Our leadership in the field of antibody-drug conjugates, or ADCs, is exemplified by our substantial progress in developing and commercializing ADCETRIS and advancing our pipeline of five other ADC candidates in clinical trials,” said Clay B. Siegall, Ph.D., President and Chief Executive Officer at Seattle Genetics. “We anticipate significant milestones during 2014, including data from the ADCETRIS phase 3 AETHERA clinical trial as well as from phase 2 clinical trials in diffuse large B-cell lymphoma (DLBCL) and salvage Hodgkin lymphoma (HL). We also anticipate reporting additional data from phase 1 clinical trials evaluating SGN-CD19A in acute lymphocytic leukemia (ALL) and non-Hodgkin lymphoma, as well as the first clinical data from a phase 1 clinical trial evaluating SGN-CD33A in acute myeloid leukemia (AML). Lastly, we anticipate advancing SGN-CD70A, our sixth ADC pipeline program, into clinical evaluation during 2014.”