Takeda UK Ltd has announced post-treatment follow up data from the pivotal phase 2 study of single-agent brentuximab vedotin for the treatment of relapsed or refractory Hodgkin lymphoma following autologous stem cell transplantation (ASCT). The data demonstrated that the estimated five-year overall survival (OS) rate among brentuximab vedotin-treated patients was 41 percent (95% CI: 31%, 51%); median OS was 40.5 months (95% CI: 28.7, 61.9 [range 1.8 to 72.9+]) and median progression-free survival (PFS) per investigator was 9.3 months (95% CI: 7.1 to 12.2 months). The safety profile of brentuximab vedotin was generally consistent with the existing prescribing information. These results were presented at the 57th American Society of Haematology (ASH) annual meeting in Orlando, FL.1
Professor Karl Peggs, Reader in Stem Cell Transplantation and Immunotherapy, University College London commented on the data: "These are interesting and provocative data. They clearly show that patients achieving a partial response require consolidation, and many would advocate allogeneic transplantation in this setting. Only those undergoing transplants maintained long term remissions in this partial response cohort. In the cohort achieving a complete response the results are more equivocal. Some of these patients did go on to allogeneic transplantation, but a small group remain in remission having not received any further therapy. The survival outcomes for the complete response cohort look very similar to those I would expect for patients undergoing allogeneic transplantation, and this does raise the question of whether these patients are best served by early transplantation or by observation followed by re-treatment with brentuximab vedotin at relapse."
Brentuximab vedotin is licensed in the UK for the treatment of adult patients with relapsed or refractory CD30+ Hodgkin lymphoma, following ASCT or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option. It is also available for the treatment of adult patients with relapsed or refractory systemic anaplastic large cell lymphoma.3 In November 2015, it was announced that brentuximab vedotin would remain available to eligible patients in England via the National Cancer Drugs Fund (nCDF) following significant negotiations between Takeda UK and NHS England. This ensures patients will have access to this innovative medicine until long-term funding is secured through the National Institute for Health and Care Excellence (NICE) appraisal in 2016. NICE approval would mean that all eligible patients across the UK would have long term access to brentuximab vedotin, given that the NHS in Scotland, Wales and Northern Ireland already funds this medicine.4-5
Jonathan Pearce, Chief Executive, Lymphoma Association commented: "It is vital that innovative treatments are being developed and made available to lymphoma patients. We want everyone affected by lymphoma to receive the best possible treatment and care, and the more options there are to improve outcomes and quality of life for patients, the better."
Also presented at the ASH annual meeting, data from the phase 3 AETHERA trial of brentuximab vedotin consolidation therapy in Hodgkin lymphoma patients at high risk of relapse following ACST demonstrated that after three years of follow-up, patients treated with brentuximab vedotin continued to show a significant improvement in PFS per investigator assessment (61%; 95% CI: 53%, 68% HR 0.52) compared to placebo (43%; 95% CI: 36%, 51%; HR 0.52). The safety profile of brentuximab vedotin was generally consistent with the existing prescribing information.2 Consolidation therapy with brentxuimab vedotin is unlicensed in the EU and a marketing authorisation application is currently ongoing.
Brentuximab vedotin is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of classical Hodgkin lymphoma.1 Brentuximab vedotin is currently approved in more than 55 countries for the treatment of relapsed or refractory Hodgkin lymphoma and systemic anaplastic large cell lymphoma (sALCL). The utility of brentuximab vedotin is currently being explored across a number of types of cancer, and data from six studies in the brentuximab vedotin clinical trial programme were presented at the ASH meeting, including four as oral presentations.