Takeda UK Ltd has reported data demonstrating that Hodgkin lymphoma (HL) patients at risk of relapse following an autologous stem cell transplant (ASCT) who received ADCETRIS (brentuximab vedotin) as consolidation therapy immediately after ASCT had significant improvement in progression-free survival (PFS) compared to patients who received placebo (median of 43 months versus 24 months, respectively; hazard ratio=0.57; p-value=0.001).1 The data from the AETHERA trial was presented in an oral session at 4.30pm PT on 8th December at the 56th American Society of Hematology (ASH) Annual Meeting. Brentuximab vedotin is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of classical HL.1 It has been approved in more than 45 countries for the treatment of relapsed or refractory HL and relapsed or refractory systemic anaplastic large cell lymphoma (sALCL) and is currently not approved in the AETHERA treatment setting.
“The AETHERA trial is the first Phase 3, comparative clinical trial for brentuximab vedotin and the positive results from this study establish the ability of brentuximab vedotin to prolong progression free survival in patients with high risk Hodgkin lymphoma who are undergoing an autologous stem cell transplant” said Karl Peggs, Reader in Stem Cell Transplantation and Immunotherapy, University College London. “The data suggest that patients with high risk Hodgkin lymphoma who are undergoing an autologous stem cell transplant may derive clinical benefit from consolidation treatment with brentuximab vedotin”.
“The AETHERA data provide compelling evidence regarding the potential utility of brentuximab vedotin as consolidation therapy post-transplant in these Hodgkin lymphoma patients, and we look forward to submitting these data to health authorities around the world,” said Michael Vasconcelles, M.D., Global Head, Oncology Therapeutic Area Unit, Takeda Pharmaceutical Company Limited. “Going forward, we are conducting a robust clinical development program to more fully understand the potential of CD30 targeting with brentuximab vedotin in frontline disease through our ongoing Phase 3 ECHELON-1 and ECHELON-2 trials in HL and mature T-cell lymphomas.”
The AETHERA Trial: Results of a Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Brentuximab Vedotin in the Treatment of Patients at Risk of Progression Following Autologous Stem Cell Transplant for Hodgkin Lymphoma (Abstract #673, oral presentation on 8th December, 2014)
The Phase 3 AETHERA trial was designed to evaluate the potential of single agent brentuximab vedotin to extend PFS post-ASCT in patients with HL who have at least one risk factor for progression. In addition to the primary endpoint of PFS, secondary endpoints included overall survival (OS), safety and tolerability. Eligible patients must have had a history of refractory HL, have relapsed within one year from receiving frontline chemotherapy and/or have had disease outside of the lymph nodes at the time of pre-ASCT relapse. These factors are consistently reported to be associated with poor prognosis after transplant. Patients received brentuximab vedotin or placebo every three weeks for up to approximately one year. This international multi-centre trial was conducted at 78 sites in the United States, Eastern and Western Europe and Russia.1
1. Moskowitz et al. The AETHERA Trial: Results of a Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Brentuximab Vedotin in the Treatment of Patients with at Risk of Progression Following Autologous Stem Cell Transplant for Hodgkin Lymphoma. Abstract No. 673. American Society of Hematology, December 2014, San Francisco, CA, USA
2. Adcetris Summary of Product Characteristics (SmPC). Available at: www.medicines.org.uk
3. Younes A, Gopal AK, Smith SE, et al. Results of a pivotal Phase II study of brentuximab vedotin for patients with relapsed or refractory Hodgkin’s lymphoma. J Clin Oncol. 2012; 30(18): 2183-9
4. Pro B et al. Brentuximab Vedotin (SGN-35) in Patients with Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma: Results of a Phase 2 study. J Clin Oncol. 2012; 30(18): 2190-6
5. Gopal et al. Three-year Follow-up Data and Characterization of Long-Term Remissions from an Ongoing Phase 2 Study of Brentuximab Vedotin in Patients with Relapsed or Refractory Hodgkin Lymphoma. Abstract No. 4382. American Society of Hematology, December, 2013, New Orleans, LA, USA
6. Pro et al. Three-Year Survival Results from an Ongoing Phase 2 Study of Brentuximab Vedotin in Patients with Relapsed or refractory Systemic Anaplastic Large Cell Lymphoma. Abstract No. 1809. American Society of Hematology, December 2013, New Orleans, LA, USA
Source: Takeda UK Ltd