Seattle Genetics, Inc. reported financial results for the first quarter ended March 31, 2013. The company also highlighted ADCETRIS (brentuximab vedotin) commercialization and clinical development activities, progress with its antibody-drug conjugate (ADC) pipeline and technology and upcoming milestones.
“In 2013 we have continued to deliver on the ambitious goals we have set for ADCETRIS, our pipeline and our ADC technology,” said Clay B. Siegall, Ph.D., President and Chief Executive Officer at Seattle Genetics. “We and our collaborator, Millennium: The Takeda Oncology Company, are bringing ADCETRIS to patients in need through approvals to date in the United States, Canada, European Union and Switzerland. In addition, across both corporate and investigator-sponsored studies, there are currently more than 20 ongoing ADCETRIS clinical trials, including four phase 3 studies. Seattle Genetics is also advancing several additional ADCs, including two programs planned for phase 1 trial initiations during 2013, while our collaborators continue to advance more than a dozen ADCs in clinical development.”
Recent ADCETRIS Highlights
• Announced that Health Canada granted approval with conditions for ADCETRIS in relapsed or refractory Hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma (sALCL).
• Received fast track designation from the U.S. Food and Drug Administration (FDA) for ADCETRIS for the frontline treatment of CD30-positive mature T-cell lymphomas. Fast track designation is a program designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.
• In collaboration with Millennium: The Takeda Oncology Company (Takeda/Millennium), initiated the ECHELON-2 global, randomized phase 3 trial comparing ADCETRIS in combination with chemotherapy to standard chemotherapy for frontline CD30-expressing mature T-cell lymphomas.
• Received orphan drug designation from the FDA for ADCETRIS in peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), providing various benefits including potential waiver of the FDA's application user fee.
• Based on a slower-than-expected rate of progressions in pooled, blinded data from the ongoing AETHERA clinical trial, updated the company’s expectation that reaching the pre-specified number of progression-free survival events needed for unblinding the trial will likely extend into 2015. In coordination with Takeda/Millennium, evaluating options to accelerate the availability of data from the trial.
• Submitted to the FDA a supplement to the biologics license application for ADCETRIS for its use in the retreatment of patients and for extended duration of use beyond 16 cycles of therapy.
• Takeda/Millennium received approval for ADCETRIS in Switzerland for two indications: (1) the treatment of patients with relapsed or refractory CD30 positive HL after autologous stem cell transplant or after a minimum of two previous treatments if a stem cell transplantation is not a treatment option, and (2) for the treatment of patients with relapsed or refractory sALCL.
• Takeda/Millennium submitted a new drug application for ADCETRIS in Japan for the treatment of relapsed or refractory HL and sALCL.