-Data Support Plans to Establish ADCETRIS as the Foundation of Therapy for a Broad Array of CD30-Positive Malignancies-
-Company Announces Novel ADC Candidate SGN-CD33A and Encouraging ADC Collaborator Data Presentations-
BOTHELL, Wash.--(BUSINESS WIRE)--Nov. 5, 2012-- Seattle Genetics, Inc. (Nasdaq:SGEN) today announced that more than a dozen abstracts, in addition to several collaborator abstracts, for both ADCETRIS (brentuximab vedotin) and investigational antibody-drug conjugates (ADCs) will be presented at the American Society of Hematology (ASH) Annual Meeting taking place in Atlanta, Georgia, December 8 – 11, 2012. ADCETRIS is an ADC directed to CD30, which is known to be expressed in Hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma (sALCL), as well as in some types of cutaneous T-cell lymphoma (CTCL), B-cell lymphomas and mature T-cell lymphomas (MTCL). Seattle Genetics is broadly evaluating CD30 expression in many other cancer types. ADCETRIS is currently not approved for use in CTCL, B-cell lymphomas, and front-line treatment of HL or MTCL.
"The comprehensive data presented at ASH 2012 support our goal to establish ADCETRIS as the foundation of therapy for a broad array of CD30-positive malignancies and redefine therapy in the front-line setting of HL and MTCL,” said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. "As a pioneer in developing ADC therapies, we continue to innovate by expanding the ADCETRIS program into CD30-positive malignancies, advancing additional ADC pipeline candidates, and supporting the progress of our collaborator ADC programs. These important advances represent our continued innovation and ADC leadership position."
Seattle Genetics is the leader in developing ADCs, a technology designed to harness the targeting ability of antibodies to deliver cell-killing agents directly to cancer cells. Of the approximately 30 ADC candidates currently in development, more than half utilize Seattle Genetics’ proprietary ADC technology. Multiple company, investigator and collaborator presentations will be presented at ASH, including data on ADCETRIS in many types of CD30-positive malignancies and preclinical data from a new ADC product candidate called SGN-CD33A. Abstract presentations planned at ASH can be found at www.hematology.org and include the following:
ADCETRIS Data in the Front-line Setting
- Results from a phase I trial evaluating front-line therapy with ADCETRIS combined with multi-agent chemotherapy in newly diagnosed advanced stage HL (Abstract number 798, oral presentation, Monday, December 10, 2012)
- Results from a phase I trial evaluating ADCETRIS in combination with multi-agent chemotherapy as front-line treatment of systemic ALCL and other types of CD30-positive MTCL (Abstract number 60, oral presentation, Sunday, December 9, 2012)
ADCETRIS Data in CTCL
- Results from a phase II trial evaluating ADCETRIS in the treatment of relapsed or refractory mycosis fungoides – the most common type of CTCL (Abstract number 797, oral presentation, Monday, December 10, 2012)
- Results from a phase II study of ADCETRIS in CD30-positive CTCL and lymphoproliferative disorders (Abstract number 3688, poster presentation, Monday, December 10, 2012)
ADCETRIS Data in Hodgkin and Non-Hodgkin Lymphomas
- Multiple data presentations on ADCETRIS in HL (Abstract numbers 3687,3689, 3699, 3701)
- Interim results from a phase II trial of ADCETRIS in relapsed or refractory CD30-positive non-Hodgkin lymphoma (NHL) (Abstract number 2746, poster presentation, Sunday, December 9, 2012)
- ADCETRIS data presentations in other CD30-positive malignancies and long-term follow-up from a pivotal trial in relapsed sALCL (Abstract numbers 1558, 2857, 2745)
Data on Other ADC Candidates and Collaborator Programs
- Preclinical antitumor activity from a novel CD33-directed ADC called SGN-CD33A in acute myeloid leukemia (AML) (Abstract number 3589, poster presentation, Monday, December 10, 2012)
- Results from phase I clinical trials of ADCs targeting CD22 and CD79b being developed by ADC collaborator Genentech (Abstract numbers 59, 56, poster presentations, Sunday, December 9, 2012)
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.
ADCETRIS received accelerated approval from the U.S. Food and Drug Administration (FDA) for two indications: (1) the treatment of patients with Hodgkin lymphoma 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 systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi-agent chemotherapy regimen. The indications for ADCETRIS are based on response rate. There are no data available demonstrating improvement in patient-reported outcomes or survival with ADCETRIS.
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.
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. The FDA granted accelerated approval of ADCETRIS in August 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, Agensys (an affiliate of Astellas), Bayer, Celldex Therapeutics, Daiichi Sankyo, Genentech, GlaxoSmithKline, Millennium, Pfizer and Progenics, as well as ADC co-development agreements with Agensys and Genmab. More information can be found at www.seattlegenetics.com.
U.S. Important Safety Information
Progressive multifocal leukoencephalopathy (PML): JC virus infection resulting in PML and death can occur in patients receiving ADCETRIS.
Concomitant use of ADCETRIS and bleomycin is contraindicated due to pulmonary toxicity.
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 symptoms of neuropathy, such as hypoesthesia, hyperesthesia, paresthesia, discomfort, a burning sensation, neuropathic pain or weakness 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 immediately and permanently discontinued and appropriate medical management instituted.
- Neutropenia: Monitor complete blood counts prior to each dose of ADCETRIS and consider more frequent monitoring for patients with Grade 3 or 4 neutropenia. If Grade 3 or 4 neutropenia develops, manage by dose delays, reductions or discontinuation. Prolonged (≥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.
- Progressive multifocal leukoencephalopathy (PML): JC virus infection resulting in PML and death has been reported in ADCETRIS-treated patients. In addition to ADCETRIS therapy, other possible contributory factors include prior therapies and underlying disease that may cause immunosuppression. Consider the diagnosis of PML in any patient presenting with new-onset signs and symptoms of central nervous system abnormalities. Evaluation of PML includes, but is not limited to, consultation with a neurologist, brain MRI, and lumbar puncture or brain biopsy. Hold ADCETRIS if PML is suspected and discontinue ADCETRIS if PML is confirmed.
- Stevens-Johnson syndrome: Stevens-Johnson syndrome has been reported with ADCETRIS. If Stevens-Johnson syndrome occurs, discontinue ADCETRIS and administer appropriate medical therapy.
- Use in pregnancy: Fetal harm can occur. Pregnant women should be advised of the potential hazard to the fetus.
ADCETRIS was studied as monotherapy in 160 patients in two phase 2 trials. Across both trials, the most common adverse reactions (≥20%), regardless of causality, were neutropenia, peripheral sensory neuropathy, fatigue, nausea, anemia, upper respiratory tract infection, diarrhea, pyrexia, rash, thrombocytopenia, cough and vomiting.
Patients who are receiving strong CYP3A4 inhibitors concomitantly with ADCETRIS should be closely monitored for adverse reactions.
For additional important safety information, including Boxed WARNING, please see the full U.S. prescribing information for ADCETRIS at www.seattlegenetics.com or www.ADCETRIS.com.
Certain of the statements made in this press release are forward looking, such as those, among others, relating to our goal to establish ADCETRIS as the foundation of therapy for a broad array of CD30-positive malignancies. 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 resulting from additional trials with ADCETRIS will not support approvals in any of the studied indications. In addition, as our other drug candidates or those of our collaborators advance in clinical trials, adverse events may occur which affect the future development of those drug candidates and possibly other compounds using similar technology. 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, 2012 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.
Source: Seattle Genetics, Inc.
Seattle Genetics, Inc.
Peggy Pinkston, 425-527-4160
Tricia Larson, 425-527-4180