Seattle Genetics, Inc.
(Nasdaq: SGEN) today summarized ADCETRIS (brentuximab vedotin) data in Hodgkin lymphoma (HL) and non-Hodgkin lymphoma from multiple presentations at the 55
American Society of Hematology (ASH) Annual Meeting and Exposition taking place in New Orleans, Louisiana, December 7-10, 2013. Highlights include encouraging interim data from a phase 2 clinical trial evaluating ADCETRIS as a single-agent for previously untreated HL patients age 60 or older and updated data from a phase 1 clinical trial of ADCETRIS in combination with chemotherapy for the treatment of newly diagnosed mature T-cell lymphoma (MTCL) patients, commonly referred to as peripheral T-cell lymphoma (PTCL). In addition, data were presented from an investigator-sponsored phase 2 clinical trial evaluating ADCETRIS in relapsed cutaneous T-cell lymphoma (CTCL). ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30. ADCETRIS is currently not approved for the treatment of frontline HL, frontline MTCL or relapsed CTCL.
“ADCETRIS is being evaluated broadly through more than 20 ongoing corporate and investigator-sponsored clinical trials in a variety of Hodgkin lymphoma and non-Hodgkin lymphoma disease settings,” said Jonathan Drachman, M.D., Chief Medical Officer and Executive Vice President, Research and Development at Seattle Genetics. “The interim data evaluating ADCETRIS as a treatment for older Hodgkin lymphoma patients are particularly encouraging, suggesting compelling activity and a manageable safety profile in a patient population that historically cannot tolerate conventional combination chemotherapy regimens and has inferior outcomes. In addition, updated data from trials evaluating ADCETRIS in both frontline mature T-cell lymphoma and cutaneous T-cell lymphoma provide strong rationale for the ongoing phase 3 ECHELON-2 and ALCANZA clinical trials.”
Frontline Data Presentations
A Phase 2 Study of Single-Agent Brentuximab Vedotin for Frontline Therapy of Hodgkin Lymphoma in Patients Age 60 Years and Above:
Data were presented from an ongoing phase 2 clinical trial evaluating ADCETRIS as frontline therapy for patients age 60 or older with previously untreated HL. The data presented are from a trial that is designed to assess the activity and tolerability of ADCETRIS as a monotherapy for older HL patients who have received no prior treatment. Interim data were reported from 19 patients. The median age of patients was 78 years (range, 64 to 92). The data were highlighted in a poster presentation by Dr. Christopher Yasenchak from the Northwest Cancer Specialists in Tualatin, OR. The key findings included:
Brentuximab Vedotin Administered Before, During, and After Multi-agent Chemotherapy in Patients with Newly-diagnosed CD30+ Mature T- and NK-cell Lymphomas
- Of the 19 patients evaluable at the time of this analysis, 17 patients (89 percent) had an objective response, including 12 (63 percent) complete remissions and five (26 percent) partial remissions.
- All 19 patients (100 percent) achieved tumor reduction as determined by best percentage change from baseline.
- The median duration of treatment was 18 weeks (six cycles) at the time of analysis.
- The most common treatment-emergent adverse events were Grade 1 or 2 and included peripheral sensory neuropathy (47 percent), fatigue (32 percent), diarrhea (26 percent), peripheral edema (26 percent), itching (26 percent), hair loss (21 percent), nausea (21 percent) and urinary tract infection (21 percent).
- Grade 3 events occurring in one patient each included peripheral sensory neuropathy, rash, neutropenia and dizziness upon standing. No Grade 4 events were observed.
Data were presented from a phase 1 clinical trial evaluating ADCETRIS administered in combination with or sequentially with chemotherapy for the treatment of newly-diagnosed MTCL. Data were reported in 13 patients who received sequential treatment with two cycles of ADCETRIS followed by six cycles of the combination chemotherapy regimen CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) and 26 patients who received the combination regimen of ADCETRIS plus CHP (A+CHP), which removes vincristine (Oncovin). The median age of patients was 57 years. The data were highlighted in a poster presentation by Dr. Michelle Fanale from The University of Texas MD Anderson Cancer Center.