Seattle Genetics to Present Brentuximab Vedotin and Dacetuzumab Clinical Data at International Conference on Malignant Lymphoma

Update: Adcetris (brentuximab vedotin) Now FDA Approved - August 19, 2011

BOTHELL, Wash.--(BUSINESS WIRE)--Jun 15, 2011 - Seattle Genetics, Inc. (Nasdaq:SGEN) today announced that data from its brentuximab vedotin (ADCETRIS™) and dacetuzumab (SGN-40) programs will be presented at the 11th International Conference on Malignant Lymphoma (ICML) being held June 15-18, 2011 in Lugano, Switzerland.

Two oral presentations on brentuximab vedotin will feature encore data from the recent American Society of Clinical Oncology (ASCO) Annual Meeting, including updated response and duration of response data from both a pivotal trial in Hodgkin lymphoma and a phase II trial in systemic anaplastic large cell lymphoma (ALCL). An oral presentation on dacetuzumab will provide complete data from a randomized phase IIb clinical trial of dacetuzumab or placebo in combination with Rituxan® (rituximab) plus ifosfamide, carboplatin and etoposide (R-ICE) chemotherapy for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). A summary of the company's ICML presentations is below and full abstracts can be accessed in a supplement to the Annals of Oncology, available online at http://annonc.oupjournals.org.

Brentuximab Vedotin

Durable remissions with SGN-35 (brentuximab vedotin): Updated results of a phase 2 study in patients with relapsed or refractory systemic anaplastic large cell lymphoma (sALCL)

 

  • Friday, June 17, 2011, 10:50 a.m. Central European Time (CET)
  • Abstract #125
  • Session 11: T-cell lymphoma
  • Presenting author: Dr. Andrei Shustov, University of Washington Medical Center, Seattle, WA

Durable complete remissions in a pivotal phase 2 study of SGN-35 (brentuximab vedotin) in patients with relapsed or refractory Hodgkin lymphoma (HL)

 

  • Saturday, June 18, 2011, 9:15 a.m. CET
  • Abstract #160
  • Session 15: Hodgkin lymphoma
  • Presenting author: Dr. Anas Younes, MD Anderson Cancer Center, Houston, TX

Dacetuzumab

A phase 2b trial comparing dacetuzumab + R-ICE vs placebo + R-ICE in patients with relapsed diffuse large B-cell lymphoma

 

  • Saturday, June 18, 2011, 8:40 a.m. CET
  • Abstract #140
  • Session: Focus on Monoclonal antibodies
  • Presenting author: Dr. Stephen Ansell, Mayo Clinic, Rochester, MN

About Brentuximab Vedotin

Brentuximab vedotin (ADCETRIS™) is an antibody-drug conjugate (ADC) comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a potent, synthetic cytotoxic 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. This approach is intended to spare non-targeted cells and thus may help minimize the potential toxic effects of traditional chemotherapy while allowing for the selective targeting of CD30-expressing cancer cells, thus potentially enhancing the antitumor activity.

Seattle Genetics is jointly developing brentuximab vedotin 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 brentuximab vedotin in the rest of the world. Seattle Genetics and the Takeda Group are funding joint development costs for brentuximab vedotin on a 50:50 basis, except in Japan where the Takeda Group will be solely responsible for development costs.

About Dacetuzumab

Dacetuzumab is a humanized monoclonal antibody that targets the CD40 antigen, which is expressed on most B lineage hematologic malignancies, as well as some solid tumors. Dacetuzumab had been evaluated in multiple clinical trials, including as a single agent as well as in combination with other agents for non-Hodgkin lymphoma and multiple myeloma.

About Seattle Genetics

Seattle Genetics is a clinical-stage biotechnology company focused on the development and commercialization of monoclonal antibody-based therapies for the treatment of cancer and autoimmune disease. The U.S. Food and Drug Administration has granted priority review to Biologics License Applications for its lead product candidate, brentuximab vedotin, for the treatment of relapsed or refractory Hodgkin lymphoma and relapsed or refractory systemic anaplastic large cell lymphoma, with a PDUFA date of August 30, 2011. Brentuximab vedotin is being developed in collaboration with Millennium: The Takeda Oncology Company. In addition, Seattle Genetics has five other clinical-stage programs: SGN-75, ASG-5ME, ASG-22ME, dacetuzumab (SGN-40) and SGN-70. 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.

Certain of the statements made in this press release are forward looking, such as those, among others, relating to the company's expectations for regulatory approval and commercial launch of brentuximab vedotin. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include risks that data from our pivotal Hodgkin lymphoma trial and phase II systemic ALCL trial of brentuximab vedotin will not support marketing approval for the submitted indications. More information about the risks and uncertainties faced by Seattle Genetics is contained in the company's 10-Q for the quarter ended March 31, 2011 filed with the Securities and Exchange Commission. Seattle Genetics disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

 

Contact: Seattle Genetics
Peggy Pinkston, 425-527-4160
ppinkston@seagen.com

 

Posted: June 2011

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