Seattle Genetics, Inc. (Nasdaq: SGEN) today reported financial results for the second quarter ended June 30, 2012. The company also highlighted progress with ADCETRIS (brentuximab vedotin) commercialization activities, ongoing and planned clinical trials and upcoming milestones.
“As the leader in developing antibody-drug conjugate therapies, we along with our many collaborators are using our technology to change the way cancer is treated,” said Clay B. Siegall, Ph.D., President and Chief Executive Officer at Seattle Genetics. “We remain focused on making ADCETRIS available to patients, and we are delivering on this priority both through continued commercial initiatives for patients in the labeled indications, as well as through our robust clinical development of ADCETRIS in earlier lines of therapy and other CD30-positive malignancies. We are also focused on advancing our robust pipeline of ADC candidates and leveraging our ADC technology in collaborations to further advance the treatment of cancer.”
Recent ADCETRIS Highlights
- Announced that Takeda Pharmaceutical Company Limited and Millennium: The Takeda Oncology Company received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the conditional approval of ADCETRIS for relapsed or refractory CD30-positive Hodgkin lymphoma (HL) and relapsed or refractory systemic anaplastic large cell lymphoma (sALCL), supporting an approval decision for ADCETRIS in the European Union.
- Announced that Health Canada has accepted for review a New Drug Submission (NDS) for the use of ADCETRIS in relapsed HL and sALCL. The NDS will be reviewed under the Health Canada policy of Notice of Compliance with Conditions.
- Received a Special Protocol Assessment (SPA) from the U.S. Food and Drug Administration (FDA) supporting the design of a planned phase III clinical trial of ADCETRIS in front-line advanced HL.
- Reported clinical data at the 2012 American Society of Clinical Oncology (ASCO) annual meeting demonstrating activity and tolerability of ADCETRIS in the retreatment setting and in CD30-positive non-Hodgkin lymphomas, including diffuse large B-cell lymphoma, as well as CD30 expression from a screening protocol in non-lymphoma malignancies. These data support further evaluation of ADCETRIS in these settings.
- Reported follow-up data at the European Hematology Association (EHA) annual meeting from the ongoing assessment of overall survival of patients treated on the pivotal clinical trial of ADCETRIS in relapsed or refractory HL after autologous stem cell transplant (ASCT). These data showed that more than 50 percent of patients were alive at a median follow-up of 26.5 months.
- Reported clinical data from an investigator-sponsored phase II clinical trial of ADCETRIS in patients with cutaneous T-cell lymphoma (CTCL) demonstrating a 75 percent objective response rate (12 of 16 patients). Adverse events were mostly Grade 1 or 2, with the most common related events being peripheral neuropathy (76 percent), fatigue (65 percent), decreased appetite (30 percent) and generalized skin eruption (30 percent). These data were presented at the Society for Investigative Dermatology annual meeting, and support further evaluation of ADCETRIS in the treatment of CTCL.
- In collaboration with Millennium, initiated an international phase III clinical trial of ADCETRIS for relapsed CD30-positive CTCL (the ALCANZA trial). The trial is being conducted under an SPA with the FDA.
- Supported initiation of three additional investigator-sponsored trials (ISTs), including trials to evaluate ADCETRIS in the treatment of graft-vs-host disease. A total of ten ADCETRIS ISTs are ongoing, and the company expects multiple additional ISTs to begin during 2012.
Other Recent Highlights
- Presented interim data from a phase I clinical trial evaluating ASG-5ME for the treatment of castration-resistant prostate cancer (CRPC) demonstrating tolerability at doses up to 3.0 milligrams per kilogram and showing preliminary evidence of antitumor activity. ASG-5ME is being developed in collaboration with Agensys, an affiliate of Astellas.
- Achieved a milestone under our ADC collaboration with Genentech triggered by Genentech’s submission of an investigational new drug (IND) application to the FDA for an ADC utilizing Seattle Genetics' technology for the treatment of cancer; Genentech has nine ADCs currently in clinical development utilizing Seattle Genetics’ technology.
- Achieved a milestone under our ADC collaboration with Millennium triggered by Millennium’s initiation of a phase I clinical trial of an ADC targeted to Guanylyl Cyclase C (GCC) for gastrointestinal malignancies.
- Completing target enrollment during the third quarter of the phase III AETHERA trial designed to evaluate the use of ADCETRIS in patients at high risk of residual HL following ASCT, also described as maintenance therapy in the post-ASCT setting.
- Anticipating that Millennium/Takeda will receive a positive decision from the European Commission by the end of 2012 regarding the ADCETRIS marketing authorization application in the European Union, following the CHMP opinion received in July 2012. Approval of ADCETRIS in the European Union will trigger $25 million in milestone payments to Seattle Genetics.
- Initiating a phase III clinical trial of ADCETRIS in front-line advanced stage HL by late 2012 or early 2013. The trial will be conducted under an SPA with the FDA.
- Initiating a phase III clinical trial of ADCETRIS in front-line mature T-cell lymphomas, including sALCL, by late 2012 or early 2013.
- Initiating a phase II clinical trial of single-agent ADCETRIS for front-line treatment of elderly patients with HL by the end of 2012.
- Expecting a review decision from Health Canada in early 2013 for ADCETRIS in relapsed HL and sALCL.
- Anticipating multiple ADCETRIS, product pipeline and ADC collaborator data presentations at upcoming medical meetings, including the American Society of Hematology (ASH) annual meeting.
- Initiating a phase Ib clinical trial to evaluate SGN-75 in combination with everolimus, an mTOR inhibitor, for advanced metastatic renal cell carcinoma.
- Submitting an IND application for SGN-CD19A, a CD19-targeted ADC, during 2012.
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