Seattle Genetics, Inc. (Nasdaq: SGEN) today reported financial results for the second quarter and six months ended June 30, 2013. The company also highlighted ADCETRIS (brentuximab vedotin) commercialization and clinical development activities, antibody-drug conjugate (ADC) pipeline and collaborator updates and upcoming milestones.
“During the second quarter, we continued to make strong progress on our key corporate priorities, including the commercialization of ADCETRIS, the broad clinical development of ADCETRIS in CD30-positive malignancies and the advancement of our product pipeline,” said Clay B. Siegall, Ph.D., President and Chief Executive Officer at Seattle Genetics. “ADCETRIS is now approved in 35 countries, and our clinical development program comprises more than 20 ongoing clinical trials, including four phase 3 studies. We recently expanded our clinical-stage product pipeline by moving SGN-CD33A, which utilizes our newest ADC technology, into a phase 1 trial and exercising our option to co-develop ASG-15ME with Agensys/Astellas. We also entered into a new ADC collaboration with Bayer.”
Recent ADCETRIS Activities
- Received notification from the U.S. Food and Drug Administration (FDA) regarding the company’s supplemental Biologics License Application (sBLA). Based on ongoing interactions with the FDA, Seattle Genetics anticipates that the 16-cycle limitation on duration of use of ADCETRIS will be removed from the U.S. prescribing information. It is further anticipated that a label claim for retreatment will not be approved. Seattle Genetics intends to submit data on the use of ADCETRIS for retreatment to guidelines review committees for potential inclusion in compendia.
- Initiated a phase 1/2 clinical trial evaluating ADCETRIS in combination with bendamustine for patients with Hodgkin lymphoma (HL) after first relapse.
- Takeda received approval for ADCETRIS in South Korea through its local affiliate.
- Highlighted the ongoing phase 3 ECHELON-1 and ECHELON-2 trials at the American Society of Clinical Oncology (ASCO) annual meeting. ECHELON-1 is comparing ADCETRIS in combination with chemotherapy to standard chemotherapy for frontline HL, and ECHELON-2 is comparing ADCETRIS in combination with chemotherapy to standard chemotherapy for frontline CD30-expressing mature T-cell lymphomas (MTCL).
- Reported data in multiple sessions at the 12 th International Conference on Malignant Lymphoma, including data from an investigator-sponsored trial in salvage HL and data from a corporate trial of ADCETRIS in B-cell and T-cell non-Hodgkin lymphomas.
ADCETRIS is currently not approved for use in frontline HL, frontline MTCL, CTCL, first relapse HL patients eligible for a transplant or the B-cell and T-cell non-Hodgkin lymphoma subtypes referenced above.