Antibody-drug conjugate results announced in mature T-cell lymphoma

Seattle Genetics, Inc. highlighted final five-year survival results from a phase 1 clinical trial evaluating Adcetris (brentuximab vedotin) in mature T-cell lymphoma (MTCL) at the 59th American Society of Hematology (ASH) Annual Meeting and Exposition taking place in Atlanta, Georgia, December 9-12, 2017. The presentation highlighted durability data from a phase 1 clinical trial of Adcetris in combination with chemotherapy for the treatment of patients with newly diagnosed MTCL, also known as peripheral T-cell lymphoma (PTCL). Adcetris is an antibody-drug conjugate (ADC) directed to CD30, which is expressed on the surface of Hodgkin lymphoma cells and several types of non-Hodgkin lymphoma. AdcetrisS is currently not approved for the frontline treatment of MTCL.

Five-Year Survival Results: Frontline Brentuximab Vedotin in Combination with CHP in Patients with CD30-Expressing Peripheral T-Cell Lymphomas (Abstract #2790, poster presentation on Sunday, December 10, 2017)

Data were reported from 26 frontline MTCL patients who received the combination regimen of Adcetris plus cyclophosphamide, doxorubicin and prednisone (CHP). Patients who achieved at least a partial remission with combination therapy following six cycles of Adcetris plus CHP were eligible to receive up to ten additional cycles of single-agent Adcetris treatment. The median age of patients was 56 years. Nineteen patients (73 percent) had a subtype of MTCL called systemic anaplastic large cell lymphoma (sALCL), including 16 patients with anaplastic lymphoma kinase (ALK)-negative disease, which is typically associated with a poor prognosis. Seven patients (27 percent) had a diagnosis of other types of MTCL. The majority of patients had advanced stage disease and were considered high risk. All patients on the trial achieved an objective response, including 92 percent with a complete response and eight percent with a partial response.

Updated key findings based on a median observation time of 60 months from first dose of therapy include: 1. At five-year follow-up, there have been no progression events or deaths in this trial since the three-year follow up. 2.The estimated five-year progression-free survival rate was 52 percent, with no patients receiving a consolidative stem cell transplant in first remission. The median progression-free survival has not yet been reached. 3.The estimated five-year overall survival rate was 80 percent. The median overall survival has not yet been reached. 4. Seventy-three percent of patients (19 of 26) experienced peripheral neuropathy, the majority of which was Grade 1 or 2. 5. Ninety-five percent of these patients had complete resolution or some improvement of their symptoms at last follow-up with a median time to resolution of 4.2 months and median time to improvement of symptoms was 2.6 months.