April - June 2011
June 13, 2011
Seattle Genetics, Inc.
Millennium Pharmaceuticals, Inc.
Takeda Pharmaceutical Company Limited
-Data demonstrate objective responses and complete remissions in relapsed or refractory Hodgkin lymphoma patients who were ineligible for or refused treatment with ASCT -
Cambridge, Mass. and Bothell, Wash. – June 11, 2011 – Millennium: The Takeda Oncology Company, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited (TSE:4502) and Seattle Genetics, Inc. (Nasdaq: SGEN), announced today that data on ADCETRIS™ (brentuximab vedotin) in relapsed or refractory Hodgkin lymphoma patients were featured in an oral presentation at the 16th Congress of the European Hematology Association (EHA) in London. The data from this retrospective analysis describe the activity and tolerability of ADCETRIS in Hodgkin lymphoma patients who were not candidates for or who refused autologous stem cell transplant (ASCT). ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, the defining marker of Hodgkin lymphoma.
“These data from our phase I trials support the activity and tolerability of ADCETRIS in patients for whom standard second-line induction therapy is not an option or has failed to produce a robust response prior to ASCT,” said Thomas C. Reynolds, M.D., Ph.D., Chief Medical Officer at Seattle Genetics. “We believe that patients in this setting represent a significant unmet medical need.”
“Further analysis of data from these phase I trials continues to add to the growing body of evidence of the potential of ADCETRIS to benefit a variety of Hodgkin lymphoma patients, including those who have not received a stem cell transplant,” said Nancy Simonian, M.D., Chief Medical Officer, Millennium.
Twenty relapsed or refractory Hodgkin lymphoma patients who were ineligible for or refused treatment with ASCT were among patients enrolled in two phase I dose-escalation trials of ADCETRIS conducted from 2006 to 2010. Six out of 20 patients (30 percent) achieved an objective response, including two (10 percent) complete remissions and four (20 percent) partial remissions. An additional 10 patients (50 percent) had stable disease. The median duration of response had not been reached at the time the trials closed. Two patients who attained complete remission maintained their remission after 10.7 and 13.8 months of follow-up, respectively.
ADCETRIS treatment was generally well tolerated, with the most common adverse events being fatigue (45 percent), nausea (40 percent), fever (35 percent), weight loss (30 percent) and diarrhea (30 percent).
ADCETRIS was evaluated in two phase I trials for patients with CD30-positive hematologic malignancies, primarily Hodgkin lymphoma. Patients received escalating doses of ADCETRIS using two different schedules of dose administration, an every three week dosing regimen and a three out of four week dosing regimen. Ten patients received doses of ADCETRIS ranging from 0.1 milligrams per kilogram (mg/kg) to 2.7 mg/kg on an every three week basis, including four patients receiving 1.2 mg/kg or lower. Ten additional patients received doses of 0.4 mg/kg to 1.4 mg/kg on a three out of four week basis, including six patients receiving 1.0 mg/kg or lower. Both trials were designed to assess the safety and activity of escalating doses of ADCETRIS in relapsed or refractory patients.
Among the 20 Hodgkin lymphoma patients in these trials who were ineligible for or refused treatment with ASCT, the median age was 32 years and patients had received a median of three prior chemotherapy regimens. (Abstract #938)
ADCETRIS™ (brentuximab vedotin) is an antibody-drug conjugate (ADC) comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a potent, synthetic drug, 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 and Millennium are jointly developing ADCETRIS. 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.
Lymphoma is a general term for a group of cancers that originate in the lymphatic system. There are two major categories of lymphoma: Hodgkin lymphoma and non-Hodgkin lymphoma. Hodgkin lymphoma is distinguished from other types of lymphoma by the presence of one characteristic type of cell, known as the Reed-Sternberg cell. A defining attribute of the Reed-Sternberg cell is its expression of the CD30 antigen. Globally, more than 30,000 cases of Hodgkin lymphoma are diagnosed annually.
Millennium: The Takeda Oncology Company, a leading biopharmaceutical company based in Cambridge, Mass., markets a first-in-class proteasome inhibitor in the US, and has a robust clinical development pipeline of global product candidates. Millennium Pharmaceuticals, Inc. was acquired by Takeda Pharmaceutical Company Ltd. in May, 2008. The Company’s research, development and commercialization activities are focused in oncology. Additional information about Millennium and Takeda are available through their respective websites, www.millennium.com and www.takeda.com.
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 FDA has granted priority review to Biologics License Applications for its lead product candidate, ADCETRIS, for the treatment of relapsed or refractory Hodgkin lymphoma and systemic anaplastic large cell lymphoma, with a PDUFA date of August 30, 2011. ADCETRIS is being developed in collaboration with Millennium: The Takeda Oncology Company. In addition, Seattle Genetics has four other clinical-stage programs: SGN-75, ASG-5ME, 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.
Located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for patients worldwide through leading innovation in medicine. Additional information about Takeda is available through its corporate website, www.takeda.com.
For Seattle Genetics: 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 ADCETRIS and initiation of future clinical trials. 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 the safety and/or efficacy results of our clinical trials of ADCETRIS, including our pivotal clinical trial for relapsed or refractory Hodgkin lymphoma and the phase II trial for relapsed or refractory systemic ALCL will not support marketing approval for the submitted indications; that we receive a complete response letter to our BLAs for other reasons, including but not limited to, not satisfactorily completing pre-approval inspections of our contract manufacturers’ or our facilities; major amendments to our marketing application that delay the planned U.S. commercial launch; and that even if we receive approval, we are delayed or unsuccessful in the commercial launch of ADCETRIS. Further, ADCETRIS may be approved pursuant to the accelerated approval regulations and we may be subject to completing post-marketing requirements and obtaining preapproval of our marketing and promotional materials. 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.
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