Seattle Genetics Inc. announced that interim results from an investigator-sponsored phase II clinical trial of ADCETRIS (brentuximab vedotin) in patients with cutaneous T-cell lymphoma (CTCL) were presented at the T-Cell Lymphoma Forum being held January 26-28, 2012 in San Francisco, CA. In addition, case studies were presented on two patients with relapsed peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS) who were treated with ADCETRIS. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30. ADCETRIS is not approved for use in CTCL or PTCL-NOS. At the time of data analysis, 17 of 23 enrolled patients had received at least two doses of ADCETRIS and were evaluable for response. All patients had relapsed CD30-positive cutaneous lymphoproliferative disorders, including lymphomatoid papulosis (LyP), primary cutaneous anaplastic large cell lymphoma (pcALCL) or mycosis fungoides (MF). Patients treated in this trial receive 1.8 milligrams per kilogram (mg/kg) of ADCETRIS every three weeks for up to a maximum of eight doses. Patients who achieve partial remission or stable disease are eligible to receive an additional eight doses. Key findings, which were presented by Dr. Madeleine Duvic from The University of Texas MD Anderson Cancer Center, include: Eleven of 17 evaluable patients (65 percent) achieved an objective response, including seven complete remissions (CRs) and four partial remissions (PRs). Six patients had stable disease. These investigator-assessed responses were observed in all three subtypes of CTCL. The most common adverse events were Grade 1, including diarrhea, chest tightness, alopecia, nausea, elevated liver enzymes and peripheral neuropathy. ADCETRIS treatment was held in two patients with Grade 2 peripheral sensory neuropathy and in one patient with Grade 4 neutropenia and Grade 3 leukopenia. One patient died of sepsis after one dose of ADCETRIS. Variable CD30 expression was observed in baseline lesions. The clinical trial is ongoing with planned enrollment of 29 patients. Data were also presented from case studies of two patients with relapsed CD30-positive PTCL-NOS who were enrolled in phase I trials of ADCETRIS. PTCL-NOS is associated with a poor prognosis and there is no well-established standard of care. Both patients were heavily pretreated, including prior autologous stem cell transplant. The first patient achieved a PR with progression-free survival of eight months and overall survival of 22 months. Adverse events considered related to ADCETRIS were Grade 2 sensory neuropathy in the fingertips and Grade 3 fatigue. The second patient achieved a CR which is still ongoing with a duration of more than 19 months. The patient had Grade 3 anemia and other Grade 1 adverse events, none of which were considered by the investigator to be related to ADCETRIS. 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 was granted accelerated approval by the U.S. Food and Drug Administration (FDA) in August 2011 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 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. ADCETRIS has not been approved for use in CTCL or PTCL-NOS. ADCETRIS is not approved for use outside the United States. The marketing authorization application for ADCETRIS in relapsed or refractory Hodgkin lymphoma and sALCL, filed by Takeda Global Research & Development Centre (Europe), was accepted by the European Medicines Agency for review in June 2011.