Seattle Genetics, Inc. (Nasdaq: SGEN) today summarized ADCETRIS (brentuximab vedotin) and CD30 expression data in non-Hodgkin lymphomas and other malignancies from multiple presentations at the 54 th American Society of Hematology (ASH) Annual Meeting and Exposition being held December 8-11, 2012 in Atlanta, GA. Highlights include encouraging interim data from a phase II clinical trial of ADCETRIS in non-Hodgkin lymphoma and long-term follow up from a pivotal clinical trial of ADCETRIS in relapsed or refractory systemic anaplastic large cell lymphoma (sALCL). In addition, investigators presented data describing the expression of CD30 in DLBCL and case studies on ADCETRIS in patients with systemic mastocytosis. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30.
“This collection of data from both corporate studies as well as investigator research into CD30 and the clinical role of ADCETRIS in non-Hodgkin lymphomas add to a growing body of evidence that ADCETRIS has potential in a broad array of CD30-positive malignancies,” said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. “The numerous data sets at ASH also reinforce our development strategy for the program and overall vision for ADCETRIS in the treatment of patients with significant unmet medical needs.”
A Phase II Study of Brentuximab Vedotin in Patients with Relapsed or Refractory CD30-Positive Non-Hodgkin Lymphomas (Abstract #2746)
In an ongoing phase II clinical trial, patients with relapsed or refractory CD30-positive non-Hodgkin lymphomas have been enrolled, including DLBCL and several other non-Hodgkin lymphoma subtypes. The trial is designed to assess the antitumor activity, duration of response and safety profile of ADCETRIS in these patients. At the time of data analysis, 73 patients had been enrolled, including 44 with B-cell lymphoma and 29 with T-cell lymphoma. The median number of prior systemic therapies in both lymphoma classifications was two. Key findings include:
- Of 64 patients evaluable for response, 22 patients (34 percent) achieved an objective response, including 12 complete remissions and ten partial remissions.
- In B-cell lymphoma subtypes, 14 of 42 evaluable patients (33 percent) achieved an objective response, including 11 of 25 DLBCL patients (44 percent).
- In T-cell lymphoma subtypes, eight of 22 evaluable patients (36 percent) achieved an objective response, including five of ten angioimmunoblastic T-cell lymphoma patients (50 percent).
- The most common treatment-emergent adverse events of any grade were fatigue (32 percent), neutropenia (26 percent), nausea (25 percent), diarrhea (23 percent) and fever (22 percent).
- The most common Grade 3 or 4 adverse event considered related to ADCETRIS treatment was neutropenia (28 percent). Other Grade 3 or 4 adverse events occurring in two patients (three percent) each included anemia, decreased appetite, hypotension and leukopenia.
- Enrollment is ongoing. For more information about this trial, visit www.clinicaltrials.gov.
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