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Millennium and Seattle Genetics Present Clinical Data on ADCETRIS(TM) (Brentuximab Vedotin) in Pediatric Patients at EMCC Annual Meeting

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Monday, September 26, 2011

Millennium: The Takeda Oncology Company, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited (TSE:4502) and Seattle Genetics, Inc. (Nasdaq: SGEN), reported data from a retrospective analysis of pediatric patients (12 - 17 yrs) enrolled in four multicenter clinical trials (two phase I and two phase II) of ADCETRIS.

All patients were diagnosed with relapsed or refractory Hodgkin lymphoma (HL) (n=5) or systemic anaplastic large cell lymphoma (sALCL) (n=4) and had failed at least one prior chemotherapy regimen. The data were reported today during an oral presentation at the 2011 European Multidisciplinary Cancer Congress being held September 23 - 27, in Stockholm, Sweden.

The marketing authorization application for ADCETRIS in relapsed or refractory HL and sALCL, filed by Takeda Global Research & Development Centre (Europe), was accepted by the European Medicines Agency in June 2011. ADCETRIS was granted accelerated approval by the U.S. Food and Drug Administration in August 2011 for two indications: (1) the treatment of patients with HL after failure of autologous stem cell transplant (ASCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not ASCT candidates, and (2) the treatment of patients with sALCL after failure of at least one prior multi-agent chemotherapy regimen. These indications are based on response rate. There are no data available demonstrating improvement in patient-reported outcomes or survival with ADCETRIS. ADCETRIS has not been approved for the treatment of pediatric patients.

"Both Hodgkin lymphoma and systemic ALCL are relatively common pediatric lymphomas, but few options are available to patients who relapse or are refractory to treatments," said Dr. Michelle Fanale, M.D. Anderson Cancer Center, Houston Texas. "It is encouraging that ADCETRIS resulted in complete remissions in six of nine patients and was generally well tolerated. These data support the further investigation of ADCETRIS in children and adolescents with CD30-positive lymphomas."

Complete Remissions Observed in a Subset of Pediatric Patients with CD30-Expressing Malignant Lymphomas Treated in Clinical Studies of Brentuximab Vedotin (SGN-35) (Abstract #9201)

Clinical response was assessed by the investigator using the Cheson 2007 Revised Response Criteria for Malignant Lymphoma.

Six of nine patients achieved a complete remission (CR) after treatment with ADCETRIS, including all four sALCL patients, and the remaining three patients achieved stable disease (SD)

Five of the 6 patients with CR remained in remission after follow-up that ranged from 3 to more than 15 months

ADCETRIS was associated with generally manageable adverse events; the most common, determined as treatment-emergent events occurring in more than 4 patients, were nausea (n=6), peripheral neuropathy (n=6), fatigue (n=5), cough (n=4), mouth and throat pain (n=4), and fever (n=4)

Adverse events of Grade 3 or higher were neutropenia (n=3), decrease in white blood cell count (n=1), thrombocytopenia (n=1), catheter site infection (n=1), and hyperesthesia (n=1)

Patients received intravenous ADCETRIS as a 30-minute outpatient infusion in weekly treatment cycles (3 out of 4 weeks) at doses of 0.8 or 1.2 milligrams per kilogram (mg/kg) or every 3 weeks at doses of 1.2 or 1.8 mg/kg. There were no deaths or discontinuations due to treatment in this subset of pediatric patients.


ADCETRIS (brentuximab vedotin) is an antibody-drug conjugate (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.

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. The ADCETRIS marketing authorization application (MAA) for relapsed or refractory Hodgkin lymphoma and systemic ALCL was accepted by the European Medicines Agency in June 2011. The MAA was filed by Takeda Global Research & Development Centre (Europe).

About Hodgkin Lymphoma and Systemic ALCL

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. The Reed-Sternberg cell generally expresses CD30. Systemic ALCL is an aggressive type of T-cell non-Hodgkin lymphoma that also expresses CD30.

About Millennium

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, and

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. Seattle Genetics' first product, ADCETRIS(TM) (brentuximab vedotin), was approved by the U.S. Food and Drug Administration 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

Important Safety Information

Warnings and Precautions:

  • Peripheral neuropathy: ADCETRIS treatment causes a peripheral neuropathy that is predominantly sensory. Cases of peripheral motor neuropathy have also been reported. ADCETRIS-induced peripheral neuropathy is cumulative. Treating physicians should monitor patients for neuropathy and institute dose modifications accordingly.
  • Infusion reactions: Infusion-related reactions, including anaphylaxis, have occurred with ADCETRIS. Monitor patients during infusion. If an infusion reaction occurs, the infusion should be interrupted and appropriate medical management instituted. If anaphylaxis occurs, the infusion should be discontinued immediately and appropriate medical management instituted.
  • Neutropenia: Monitor complete blood counts prior to each dose of ADCETRIS. If Grade 3 or 4 neutropenia develops, manage by dose delays, reductions or discontinuation. Prolonged (greater-than or equal to 1 week) severe neutropenia can occur with ADCETRIS.
  • Tumor Lysis Syndrome: Patients with rapidly proliferating tumor and high tumor burden are at risk of tumor lysis syndrome and these patients should be monitored closely and appropriate measures taken.
  • Stevens-Johnson syndrome: Stevens-Johnson syndrome has been reported with ADCETRIS. If Stevens-Johnson syndrome occurs, discontinue ADCETRIS and administer appropriate medical therapy.
  • Progressive Multifocal Leukoencephalopathy (PML): A fatal case of PML has been reported in a patient who received four chemotherapy regimens prior to receiving ADCETRIS.
  • Use in pregnancy: Fetal harm can occur. Pregnant women should be advised of the potential hazard to the fetus.

Adverse Reactions:

ADCETRIS was studied as monotherapy in 160 patients in two phase II trials. Across both trials, the most common adverse reactions (greater-than or equal to 20%), regardless of causality, were neutropenia, peripheral sensory neuropathy, fatigue, nausea, anemia, upper respiratory tract infection, diarrhea, pyrexia, rash, thrombocytopenia, cough and vomiting.

Drug Interactions:

Patients who are receiving strong CYP3A4 inhibitors concomitantly with ADCETRIS should be closely monitored for adverse reactions.

For additional important safety information, please see the full prescribing information for ADCETRIS at or

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 future clinical trials of ADCETRIS in pediatric patients. 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 related to adverse clinical results as ADCETRIS advances in clinical trials. More information about the risks and uncertainties faced by Seattle Genetics is contained in the company's 10-Q for the quarter ended June 30, 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.

David Albaugh, 617-444-4457


Seattle Genetics
Peggy Pinkston, 425-527-4160
Source: Seattle Genetics, Inc.
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