Takeda reveals five-year Adcetris survival data
pharmafile | December 6, 2015 | News story | Research and Development, Sales and Marketing | Hodgkin lymphoma, Takeda, oncology
Takeda UK has announced post-treatment follow up data from the pivotal Phase II study of Adcetris revealing a five-year survival rate of 41%.
The study looked at Adcetris (brentuximab vedotin) as a treatment for relapsed or refractory Hodgkin’s lymphoma following autologous stem cell transplantation (ASCT).
The data demonstrated that the median OS was 40.5 months and median progression-free survival (PFS) per investigator was 9.3 months and that the safety profile of brentuximab vedotin was generally consistent with the existing prescribing information.
Professor Karl Peggs, reader in stem cell transplantation and immunotherapy at University College London, comments: “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.”
Adcetris is approved 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.
In November 2015, it was announced that Adcetris would remain available to eligible patients in England via NHS England’s Cancer Drugs Fund following significant negotiations between Takeda UK and NHS England. The drug had been one of those originally earmarked for removal from the Fund in September.
This ensures patients will have access to this innovative medicine until a decision about the drug’s long-term funding is made through the NICE appraisal in 2016. NICE approval would give all eligible patients across the UK long term access to Adcetris. The NHS in Scotland, Wales and Northern Ireland already funds this medicine.
Jonathan Pearce, who is chief executive of the Lymphoma Association, comments: “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.”
Adcetris is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of classical Hodgkin’s lymphoma. It is currently approved in more than 55 countries for the treatment of relapsed or refractory Hodgkin’s lymphoma and systemic anaplastic large cell lymphoma.
Joel Levy
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