Updated Data Show Promising Results for ADCETRIS in Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma
Seattle Genetics, Inc. and Millennium: The Takeda Oncology Company announced updated data from a pivotal trial of single-agent ADCETRIS in relapsed or refractory systemic anaplastic large cell lymphoma (sALCL) at the 53rd American Society of Hematology (ASH) Annual Meeting and Exposition in December 2011. The trial showed that 59 percent of patients achieved a complete remission, with a median duration of complete remissions not yet reached after a median follow-up of 14.7 months.
Key Takeaways:
- The pivotal trial was conducted in 58 relapsed or refractory sALCL patients, with a median age of 52 years and a median of two prior chemotherapy regimens.
- Eighty-six percent of patients achieved an objective response, with a median duration of 13.2 months.
- Fifty-nine percent of patients achieved a complete remission, with a median follow-up of 14.7 months.
- Median progression-free survival (PFS) in patients treated with ADCETRIS was 14.5 months, compared to 5.9 months for the most recent prior therapy received by these patients.
- Median PFS of anaplastic lymphoma kinase (ALK)-positive patients was 14.6 months, compared to 14.3 months in ALK-negative patients.
- Estimated overall survival rate of patients at one year was 70 percent.
- The most common adverse events considered related to ADCETRIS of any Grade were peripheral sensory neuropathy (45 percent), fatigue (28 percent), nausea (28 percent), diarrhea (19 percent), neutropenia (17 percent), and myalgia (16 percent).
Statistics:
- 86% of patients achieved an objective response with a median duration of 13.2 months
- 59% of patients achieved a complete remission with a median follow-up of 14.7 months
- Median progression-free survival (PFS) in patients treated with ADCETRIS was 14.5 months
- Median PFS of anaplastic lymphoma kinase (ALK)-positive patients was 14.6 months
- Estimated overall survival rate of patients at one year was 70%
Sources:
- Seattle Genetics Press Release, December 10, 2011
- American Society of Hematology (ASH) Annual Meeting and Exposition, 2011
- Brentuximab Vedotin in Patients with Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma: A Phase 2 Study Update (Abstract #443)