April - June 2011
June 13, 2011
Seattle Genetics, Inc.
Millennium Pharmaceuticals, Inc.
Takeda Pharmaceutical Company Limited
-14 out of 15 patients (93 percent) achieved complete resolution of malignant cutaneous lesions in phase II systemic ALCL trial -
Cambridge, Mass., and Bothell, Wash. – June 10, 2011 – Millennium: The Takeda Oncology Company, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited (TSE:4502) and Seattle Genetics, Inc. (Nasdaq: SGEN), today reported data from a sub-analysis of the registration-enabling phase II clinical trial of ADCETRIS™ (brentuximab vedotin) in relapsed or refractory systemic anaplastic large cell lymphoma (sALCL). ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, which is highly expressed in sALCL. The data were presented today during a poster presentation at the 16th Congress of the European Hematology Association (EHA) being held June 9-12, 2011 in London.
In a phase II trial of 58 relapsed or refractory sALCL patients, 15 patients also had cutaneous involvement of their disease at the time of enrollment. The data presented here were part of a retrospective analysis to characterize the response of malignant cutaneous lesions in patients who participated in the phase II trial of ADCETRIS in sALCL. Based on investigator assessment, 14 of the 15 patients (93 percent) achieved complete resolution of their cutaneous lesions after a median of 4.9 weeks of treatment with ADCETRIS. Based on independent central review, all 15 patients (100 percent) achieved an objective response to their systemic disease, including 13 (87 percent) complete remissions and two (13 percent) partial remissions. The median duration of objective response among these 15 patients was 12.6 months, with nine responses ongoing.
ADCETRIS treatment was generally well tolerated, with the most common adverse events being diarrhea (n=9), fever (n=7), constipation (n=6), nausea (n=6) and peripheral sensory neuropathy (n=6). The most common Grade 3 or higher adverse events were neutropenia (n=4), diarrhea (n=2), and peripheral sensory neuropathy (n=2).
“Malignant cutaneous lesions frequently occur in patients with systemic ALCL, and can be painful and disfiguring for these patients,” said Dr. Ranjana Advani, Associate Professor of Medicine/Oncology at Stanford University Medical Center. “The fact that treatment with ADCETRIS resulted in 93 percent complete resolution of these lesions and is generally well tolerated is encouraging. The data support the further investigation of ADCETRIS in patients with CD30-positive cutaneous T-cell lymphomas.”
The single arm, phase II systemic ALCL trial was designed to assess the efficacy and safety of single-agent ADCETRIS in relapsed or refractory patients. Patients received 1.8 milligrams per kilogram of ADCETRIS every three weeks. The primary endpoint of the trial was objective response rate as assessed by an independent central review. Secondary endpoints included complete response rate, duration of response, progression-free survival, overall survival and tolerability. The data presented here were part of a retrospective analysis to characterize the response of malignant cutaneous lesions in patients who participated in the phase II trial of ADCETRIS in sALCL.
Among the 15 patients with cutaneous involvement, the median age was 57 years. These patients had received a median of two prior chemotherapy regimens. Fifty-three percent of these patients were refractory to front-line therapy, and 33 percent were refractory to their most recent treatment. Eighty percent of these patients were anaplastic lymphoma kinase (ALK) negative, generally suggesting a poorer prognosis than ALK positive patients. (Abstract #1042)
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. ALCL is an aggressive type of T-cell non-Hodgkin lymphoma that highly expresses CD30. Malignant cutaneous lesions are a known complication of systemic ALCL, occurring in approximately 12 percent of newly diagnosed patients.
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™ (brentuximab vedotin), 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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