Seattle Genetics, Inc.
(NASDAQ:SGEN) today highlighted ADCETRIS (brentuximab vedotin) data at the 2014 Bone Marrow Transplant (BMT) Tandem Meetings being held February 26 to March 2, 2014, in Dallas, Texas. Presentations included the first report from an ongoing phase 1/2 clinical trial evaluating the combination of ADCETRIS and bendamustine in the treatment of salvage Hodgkin lymphoma (HL). In addition, a poster presentation summarized the clinical trial design and pooled patient demographics from the phase 3 AETHERA trial in patients with increased risk factors for HL progression following autologous stem cell transplant (ASCT). ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, which is expressed in classical HL and systemic anaplastic large cell lymphoma (sALCL).
“We are focused on exploring the potential to improve outcomes in earlier lines of HL by incorporating ADCETRIS in novel settings, and the data presented at the 2014 BMT Tandem Meetings illustrate this goal,” said Jonathan Drachman, M.D., Chief Medical Officer and Executive Vice President, Research and Development, at Seattle Genetics. “The interim data presented today evaluating ADCETRIS and bendamustine combination therapy in the salvage HL setting are encouraging, showing a complete remission rate of 77 percent, with another 15 percent of patients, who currently remain on treatment, achieving early partial remissions. In addition, a pooled analysis for the overall population in the AETHERA phase 3 clinical trial was presented, including demographic data, baseline disease characteristics and treatment exposure. We look forward to presenting efficacy and safety data from the AETHERA trial in the second half of 2014.”
A Phase 1/2 Single-Arm, Open-Label Study to Evaluate the Safety and Efficacy of Brentuximab Vedotin in Combination with Bendamustine for Patients with Hodgkin Lymphoma in the First Salvage Setting: Interim Results (Abstract #230, poster presentation on Wednesday, February 26, 2014, at 6:45 PM CT)
Interim data from an ongoing phase 1/2 clinical trial were reported from 23 patients with HL after first relapse. The multi-phase study was divided into two cohorts to determine the recommended dose and tolerability of ADCETRIS in combination with bendamustine and to assess the complete remission rate associated with combination use. Bendamustine is an alkylating agent used in the treatment of chronic lymphocytic leukemias and lymphomas. In this trial, patients are eligible to receive up to six cycles of ADCETRIS in combination with bendamustine followed by additional single-agent ADCETRIS for a total of 16 cycles. As a part of the trial design, after patients receive ADCETRIS plus bendamustine combination therapy, they have the option to pause therapy to receive an ASCT and then resume treatment with single-agent ADCETRIS as consolidation. The median age of patients enrolled in the trial was 43 years. At the time of data analysis, 23 patients were evaluable for safety and 13 were evaluable for response. Key findings include:
- After a median of two cycles of therapy, 92 percent of patients evaluable for response (12 of 13 patients) achieved an objective response, including 77 percent (ten patients) with complete remissions and 15 percent (two patients) with partial remissions. At the time of analysis, the two patients with partial remissions had each received two cycles of therapy and treatment was ongoing.
- At the time of the analysis, seven patients had undergone an ASCT and three had restarted ADCETRIS as monotherapy.
- The most common adverse events were nausea (57 percent), rash (39 percent), fever (35 percent), fatigue (30 percent) and vomiting (30 percent).
- The most common Grade 3 or 4 adverse event was lymphopenia (13 percent Grade 3; nine percent Grade 4).
- Infusion reactions considered related to combination therapy were reported as serious adverse events in six patients and led to treatment discontinuation for three patients. Symptoms included rash, hives, itching, shortness of breath, wheezing, throat tightness, fever, chills and hypotension. As a result, the protocol is being amended to require premedication with corticosteroids and antihistamines.
- Enrollment is ongoing to include up to 50 patients at multiple centers in the United States. For more information about this trial, visit www.clinicaltrials.gov.
ADCETRIS is not approved for salvage HL patients who are deemed eligible for ASCT.