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Seattle Genetics Reports Data From Phase I Trial Of ADCETRIS® (Brentuximab Vedotin) In Front-line Mature T-Cell Lymphomas (MTCL)

Brentuximab Vedotin Administered Concurrently with Multi-Agent Chemotherapy as Front-line Treatment of ALCL and Other CD30-Positive Mature T-Cell and NK-Cell Lymphomas (Abstract #60)

Data were reported from 26 previously untreated patients who received the combination regimen of ADCETRIS plus CHP. Nineteen patients had sALCL, and seven patients had a diagnosis of another mature T- or NK-cell lymphoma. The median age of patients was 56 years. Key findings, which were highlighted in an oral presentation by Dr. Fanale, include:
  • All 26 patients (100 percent) achieved an objective response after either completing six cycles of combination therapy or at the latest assessment for three patients who discontinued treatment prior to cycle six. Twenty-three patients (88 percent) achieved a complete remission and three patients (12 percent) achieved a partial remission.
  • Among 19 sALCL patients, 19 (100 percent) achieved an objective response, including 16 (84 percent) with a complete remission.
  • Among the seven non-sALCL patients, 100 percent achieved a complete remission with combination therapy, including two patients with PTCL – not otherwise specified (PTCL-NOS), two patients with angioimmunoblastic T-cell lymphoma, two patients with adult T-cell leukemia/ lymphoma and one patient with enteropathy-associated T-cell lymphoma.
  • Median progression-free survival and median overall survival have not been reached with a median follow-up of nine months.
  • Patients received a median of six cycles of CHP plus ADCETRIS and a median of six additional cycles of single-agent ADCETRIS.
  • The maximum tolerated dose of ADCETRIS in combination with CHP was not exceeded at 1.8 milligrams per kilogram (mg/kg).
  • The most common treatment-emergent adverse events of any grade regardless of relationship occurring in more than 30 percent of patients were nausea (62 percent), peripheral sensory neuropathy (62 percent), diarrhea (58 percent), fatigue (54 percent) and alopecia (46 percent).
  • The most common Grade 3 or 4 treatment-emergent adverse events regardless of relationship included Grade 3 febrile neutropenia, peripheral sensory neuropathy, nausea and dyspnea and Grade 4 nausea and diarrhea.

“These data provide strong rationale for our planned phase III clinical trial to evaluate ADCETRIS plus CHP compared to CHOP in front-line patients with mature T-cell lymphomas,” said Clay B. Siegall, Ph.D., President and Chief Executive Officer at Seattle Genetics. “We are encouraged by the potential to introduce ADCETRIS into a novel regimen for these patients, with a goal of redefining front-line therapy from the standard therapeutic approach that has not seen an advance in decades.”

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