Seattle Genetics, Inc. (Nasdaq:SGEN) today reported financial results for the fourth quarter and twelve months ended December 31, 2012. The company also highlighted ADCETRIS (brentuximab vedotin) commercialization and clinical development activities, its antibody-drug conjugate (ADC) pipeline and collaborator progress as well as upcoming milestones.
“We are strongly positioned to continue delivering on our goal of bringing ADCETRIS to patients through commercial execution. Additionally, we are building upon encouraging data in earlier lines of therapy and a range of CD30-positive malignancies through our clinical development and regulatory activities,” said Clay B. Siegall, Ph.D., President and Chief Executive Officer at Seattle Genetics. “There are more than 20 ongoing ADCETRIS clinical trials, including four phase III trials, designed to broadly explore its therapeutic potential. In addition, we have made important progress in advancing six other ADCs in clinical and preclinical development, and our ADC technology is being broadly applied in more than a dozen clinical development programs by our collaborators. Our strong financial position and cash flow from product sales and collaborations enable us to continue building value in the company.”
Recent ADCETRIS Highlights
- Announced that Health Canada has granted a Notice of Compliance with conditions (NOC/c), approving ADCETRIS for relapsed or refractory Hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma (sALCL).
- Announced that Takeda Pharmaceutical Company Limited and Millennium: The Takeda Oncology Company received European Commission conditional marketing authorization for ADCETRIS for relapsed or refractory CD30-positive HL and relapsed or refractory sALCL. The approvals triggered milestone payments to Seattle Genetics totaling $25 million.
- Reported data from more than a dozen abstracts at the American Society of Hematology (ASH) annual meeting on the investigation of ADCETRIS in a range of CD30-positive malignancies, including front-line HL, front-line mature T-cell lymphoma (MTCL), cutaneous T-cell lymphoma (CTCL) and relapsed diffuse large B-cell lymphoma (DLBCL).
- In collaboration with Millennium, initiated a global phase III clinical trial of ADCETRIS in combination with chemotherapy for front-line advanced HL (the ECHELON-1 trial). The trial is being conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) provided scientific advice.
- In collaboration with Millennium, initiated a global phase III clinical trial of ADCETRIS in combination with chemotherapy for front-line MTCL (the ECHELON-2 trial). The trial is being conducted under a SPA agreement with the FDA and the EMA provided scientific advice.
- Initiated a phase II trial in front-line HL patients age 60 or older. The trial is designed to assess the efficacy and tolerability of single-agent ADCETRIS for patients who have received no prior treatment.
ADCETRIS is not approved in front-line HL, front-line MTCL or in DLBCL.