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Current Standard of Care

Adcetris (Brentuximab Vedotin): A New Treatment Strategy for Relapsed or Refractory Hodgkin Lymphoma (HL) and Systemic Anaplastic Large Cell Lymphoma (ALCL). Current Standard of Care. Approximately 5 -10% of HL patients are refractory to initial treatment

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Current Standard of Care

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  1. Adcetris (Brentuximab Vedotin): A New Treatment Strategy for Relapsed or Refractory Hodgkin Lymphoma (HL) and Systemic Anaplastic Large Cell Lymphoma (ALCL)

  2. Current Standard of Care Approximately 5 -10% of HL patients are refractory to initial treatment Approximately 10 -30% of HL patients will relapse after achieving an initial complete remission High-dose chemotherapy (HDCT) followed by autologous stem cell transplantation (ASCT) is the standard of care for patients who are initially refractory to therapy or who relapse following a response to treatmentAnsell SM, Armitage JO. Management of Hodgkin lymphoma. Mayo Clin Proc 2006;81:419-26

  3. Limitations of Existing Strategies “Patients with relapsed or refractory CD30-positive lymphoproliferative disorders such as Hodgkin’s lymphoma and anaplastic large-cell lymphoma commonly have a poor prognosis. Patients with these histologies who subsequently progress after salvage chemotherapy and autologous stem cell transplantation have very limited treatment options and are in need of novel effective therapies.” Ansell SM. Expert Opin Investig Drugs. 2011 Jan;20(1):99-105. Epub 2010 Dec 2.

  4. Limitations of Existing Strategies Approximately 1300 deaths result from disease progression after ASCT each year in the USA Survival after ASCT failure is approximately 26 months Treatment-related mortality at 1 year is approximately 20% with 2-year overall survival at only 50% in patients who progressed after ASCT and were treated with reduced intensity allogeneic stem cell transplantation Kewalramani T, Nimer SD, Zelenetz AD, et al. Progressive disease following autologous transplantation in patients with chemosensitive relapsed or primary refractory Hodgkin’s disease or aggressive non-Hodgkin’s lymphoma. Bone Marrow Transplant 2003;32:673-9 Robinson SP, Goldstone AH, Mackinnon S, et al. Chemoresistant or aggressive lymphoma predicts for a poor outcome following reduced-intensity allogeneic progenitor cell transplantation: an analysis from the Lymphoma Working Party of the European Group for Blood and Bone Marrow Transplantation. Blood 2002;100:4310-16

  5. Brentuximab Vedotin: Mode of Action

  6. Brentuximab Vedotin: HL Trial Chen et al (2010) undertook a pivotal phase II trial on patients (n=102) with refractory or relapsed HL All had previously received an ASCT and the median number of pior chemotherapy regimens was 4 More than 70% had primary refractory disease and 39%were refractory to most recent prior therapy excluding ASCT Chen R, Gopal AK, Smith SE, et al. Results of a pivotal phase 2 study of brentuximab vedotin (SGN-35) in patients with relapsed or refractory hodgkin lymphoma [abstract #283]. American Society of Hematology Annual Meeting 2010

  7. Brentuximab Vedotin: HL Trial • Results: • Median treatment time was 27 weeks • Median number of cycles was 9 • Overall response rate was 75% • Reduction in the tumor size was evident in 95% of patients • Chen R, Gopal AK, Smith SE, et al. Results of a pivotal phase 2 study of brentuximab vedotin (SGN-35) in patients with relapsed or refractory hodgkin lymphoma [abstract #283]. American Society of Hematology Annual Meeting 2010

  8. Brentuximab Vedotin: HL Trial

  9. Brentuximab Vedotin: ALCL Trial Sustov et al (2010) undertook a phase II study on patients with systemic ALCL (n=58) Results have been repotrted on the first 30 patients Patients had a mean of two prior chemotherpay regimens and eight (27%) had failed ASCT Primary refractory disease was present in 19 (63%) and 16 (53%) had not responded to the most recent prior therapy Shustv AR, Advani R, Brice P, et al. Complete remissions with brentuximab vedotin (SGN-35) in patients with relapsed or refractory systemic anaplastic large cell lymphoma [abstract #961]. American Society of Hematology Annual Meeting 2010

  10. Brentuximab Vedotin: ALCL Trial • Objective response rate was 87% • Results: • Complete remission was achieved in 57% of patients (n = 17) • Partial remission was seen in 30% of patients (n = 9) • A reduction in tumor size was observed in 97% of patients • Mean time to objective response rate was 6 weeks • Duration of objective responses ranged from 4-36 weeks • Chen R, Gopal AK, Smith SE, et al. Results of a pivotal phase 2 study of brentuximab vedotin (SGN-35) in patients with relapsed or refractory hodgkin lymphoma [abstract #283]. American Society of Hematology Annual Meeting 2010

  11. Brentuximab Vedotin: ALCL Trial

  12. FDA Approves Adcetris (Brentuximab Vedotin) “Early clinical data suggest that patients who received Adcetris for Hodgkin lymphoma and systemic anaplastic lymphoma experienced a significant response to the therapy.” Adcetris is the first new FDA-approved treatment for HL since 1977 and the first specifically indicated to treat ALCL. Richard Pazdur, M.D., director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm268781.htm

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