Seattle Genetics, Inc. (Nasdaq: SGEN) today reported financial results for the third quarter and nine months ended September 30, 2013. The company also highlighted ADCETRIS (brentuximab vedotin) commercialization and clinical development activities, progress with its antibody-drug conjugate (ADC) pipeline, collaborator updates and upcoming milestones.
“We ended the third quarter in a strong financial position, driven by ADCETRIS net sales and collaboration revenues, leading us to increase our full year 2013 guidance in both areas. We expect several milestones over the remainder of the year, notably reporting data from multiple abstracts at the ASH annual meeting in December and advancing an additional ADC into clinical trials,” said Clay B. Siegall, Ph.D., President and Chief Executive Officer at Seattle Genetics. “Highlights of our recent progress include securing a revised ADCETRIS U.S. label that removes the 16-cycle limitation on duration of therapy, advancing our broad clinical development of ADCETRIS including starting a phase 2 trial in frontline diffuse large B-cell lymphoma, and continuing to innovate within our product pipeline by initiating phase 1 clinical trials of two new ADCs, SGN-CD33A and SGN-LIV1A.”
Recent ADCETRIS Highlights
- Completed treatment of all patients on the phase 3 AETHERA trial. Seattle Genetics and its collaborator, Millennium: The Takeda Oncology Company (Takeda), continue to evaluate options that could enable unblinding of the data before the end of 2014.
- Obtained approval for U.S. prescribing information from the U.S. Food and Drug Administration (FDA) that removes the 16-cycle limitation on duration of ADCETRIS use.
- Received orphan drug designation from the FDA for angioimmunoblastic T-cell lymphoma (AITL), an aggressive type of mature T-cell lymphoma (MTCL).
- Initiated a phase 2 frontline trial of ADCETRIS in combination with standard therapy (R-CHOP) for patients with newly diagnosed diffuse large B-cell lymphoma.
- Takeda received approval for ADCETRIS in Ukraine through its local affiliate.
- Reported on multiple presentations at the 9 th International Symposium on Hodgkin Lymphoma (ISHL), including data highlighting the evaluation of ADCETRIS in the frontline and salvage settings.
ADCETRIS is currently not approved for use in frontline and salvage settings for Hodgkin lymphoma, AITL or B-cell non-Hodgkin lymphoma.