Seattle Genetics has initiated a phase II clinical trial of ADCETRIS (brentuximab vedotin) for patients with CD30-positive non-lymphoma malignancies
BOTHELL, WA, USA I October 25, 2011 I Seattle Genetics, Inc. (Nasdaq:SGEN – News) today announced that it has initiated a phase II clinical trial of ADCETRIS™ (brentuximab vedotin) for patients with CD30-positive non-lymphoma malignancies, including multiple myeloma, leukemia and solid tumors. The trial is designed to assess the antitumor activity and safety profile of ADCETRIS in these patients. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30. On August 19, 2011, the U.S. Food and Drug Administration granted accelerated approval of ADCETRIS for two indications. ADCETRIS has not been approved for use in any non-lymphoma malignancies.
“This is the first clinical trial of ADCETRIS that expands our investigation beyond lymphoma,” said Thomas C. Reynolds, M.D., Ph.D., Chief Medical Officer of Seattle Genetics. “There are reports in published literature of CD30 expression in multiple myeloma, several types of leukemia and solid tumors. Through both corporate-sponsored and investigator-sponsored trials, our development plan is designed to broadly evaluate the potential of ADCETRIS in many types of CD30-positive malignancies.”
The phase II trial is enrolling patients with CD30-positive non-lymphoma malignancies who have failed, refused or have been deemed ineligible for standard therapy. Assessment of CD30 expression will be performed according to a Seattle Genetics screening protocol. The screening protocol facilitates high-throughput assessment of CD30 expression in patients with a variety of non-lymphoma malignancies to identify those eligible for the clinical trial. The primary endpoint of the phase II trial is characterization of the antitumor activity of ADCETRIS. In addition, the trial will assess safety and establish the relationship of CD30 expression with antitumor activity. The study is expected to enroll approximately 40 patients at multiple centers in the United States.
About ADCETRIS
ADCETRIS (brentuximab vedotin) is an ADC comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seattle Genetics’ proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing tumor cells.
In addition to the non-lymphoma trial, ADCETRIS is being evaluated in a phase III clinical trial (the AETHERA trial) for patients at high risk of residual Hodgkin lymphoma following autologous stem cell transplant (ASCT), a phase II trial for relapsed or refractory non-Hodgkin lymphoma patients, a phase II retreatment trial for relapsed patients who previously responded to ADCETRIS, a phase I trial in combination with multi-agent chemotherapy for front-line treatment of Hodgkin lymphoma and a phase I trial in combination with multi-agent chemotherapy for front-line treatment of systemic ALCL. A phase III trial in CD30-positive cutaneous T-cell lymphomas is planned for the first half of 2012.
Seattle Genetics is developing ADCETRIS in collaboration with Millennium: The Takeda Oncology Company. Under the terms of the collaboration agreement, Seattle Genetics has U.S. and Canadian commercialization rights and the Takeda Group has rights to commercialize ADCETRIS in the rest of the world. Seattle Genetics and the Takeda Group are funding joint development costs for ADCETRIS on a 50:50 basis, except in Japan where the Takeda Group will be solely responsible for development costs.
About Seattle Genetics
Seattle Genetics is a biotechnology company focused on the development and commercialization of monoclonal antibody-based therapies for the treatment of cancer. ADCETRIS™ was approved by the FDA on August 19, 2011 for two indications. ADCETRIS is being developed in collaboration with Millennium: The Takeda Oncology Company. In addition, Seattle Genetics has three other clinical-stage ADC programs: SGN-75, ASG-5ME and ASG-22ME. Seattle Genetics has collaborations for its ADC technology with a number of leading biotechnology and pharmaceutical companies, including Abbott, Bayer, Celldex Therapeutics, Daiichi Sankyo, Genentech, GlaxoSmithKline, Millennium, Pfizer and Progenics, as well as ADC co-development agreements with Agensys, an affiliate of Astellas, and Genmab. More information can be found at www.seattlegenetics.com.
SOURCE: Seattle Genetics
Post Views: 43
Seattle Genetics has initiated a phase II clinical trial of ADCETRIS (brentuximab vedotin) for patients with CD30-positive non-lymphoma malignancies
BOTHELL, WA, USA I October 25, 2011 I Seattle Genetics, Inc. (Nasdaq:SGEN – News) today announced that it has initiated a phase II clinical trial of ADCETRIS™ (brentuximab vedotin) for patients with CD30-positive non-lymphoma malignancies, including multiple myeloma, leukemia and solid tumors. The trial is designed to assess the antitumor activity and safety profile of ADCETRIS in these patients. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30. On August 19, 2011, the U.S. Food and Drug Administration granted accelerated approval of ADCETRIS for two indications. ADCETRIS has not been approved for use in any non-lymphoma malignancies.
“This is the first clinical trial of ADCETRIS that expands our investigation beyond lymphoma,” said Thomas C. Reynolds, M.D., Ph.D., Chief Medical Officer of Seattle Genetics. “There are reports in published literature of CD30 expression in multiple myeloma, several types of leukemia and solid tumors. Through both corporate-sponsored and investigator-sponsored trials, our development plan is designed to broadly evaluate the potential of ADCETRIS in many types of CD30-positive malignancies.”
The phase II trial is enrolling patients with CD30-positive non-lymphoma malignancies who have failed, refused or have been deemed ineligible for standard therapy. Assessment of CD30 expression will be performed according to a Seattle Genetics screening protocol. The screening protocol facilitates high-throughput assessment of CD30 expression in patients with a variety of non-lymphoma malignancies to identify those eligible for the clinical trial. The primary endpoint of the phase II trial is characterization of the antitumor activity of ADCETRIS. In addition, the trial will assess safety and establish the relationship of CD30 expression with antitumor activity. The study is expected to enroll approximately 40 patients at multiple centers in the United States.
About ADCETRIS
ADCETRIS (brentuximab vedotin) is an ADC comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seattle Genetics’ proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing tumor cells.
In addition to the non-lymphoma trial, ADCETRIS is being evaluated in a phase III clinical trial (the AETHERA trial) for patients at high risk of residual Hodgkin lymphoma following autologous stem cell transplant (ASCT), a phase II trial for relapsed or refractory non-Hodgkin lymphoma patients, a phase II retreatment trial for relapsed patients who previously responded to ADCETRIS, a phase I trial in combination with multi-agent chemotherapy for front-line treatment of Hodgkin lymphoma and a phase I trial in combination with multi-agent chemotherapy for front-line treatment of systemic ALCL. A phase III trial in CD30-positive cutaneous T-cell lymphomas is planned for the first half of 2012.
Seattle Genetics is developing ADCETRIS in collaboration with Millennium: The Takeda Oncology Company. Under the terms of the collaboration agreement, Seattle Genetics has U.S. and Canadian commercialization rights and the Takeda Group has rights to commercialize ADCETRIS in the rest of the world. Seattle Genetics and the Takeda Group are funding joint development costs for ADCETRIS on a 50:50 basis, except in Japan where the Takeda Group will be solely responsible for development costs.
About Seattle Genetics
Seattle Genetics is a biotechnology company focused on the development and commercialization of monoclonal antibody-based therapies for the treatment of cancer. ADCETRIS™ was approved by the FDA on August 19, 2011 for two indications. ADCETRIS is being developed in collaboration with Millennium: The Takeda Oncology Company. In addition, Seattle Genetics has three other clinical-stage ADC programs: SGN-75, ASG-5ME and ASG-22ME. Seattle Genetics has collaborations for its ADC technology with a number of leading biotechnology and pharmaceutical companies, including Abbott, Bayer, Celldex Therapeutics, Daiichi Sankyo, Genentech, GlaxoSmithKline, Millennium, Pfizer and Progenics, as well as ADC co-development agreements with Agensys, an affiliate of Astellas, and Genmab. More information can be found at www.seattlegenetics.com.
SOURCE: Seattle Genetics
Post Views: 43
