Adcetris (brentuximab vedotin, SGN-35) is an approved therapy for classical Hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma (sALCL) developed through collaboration between Millenium Pharmaceuticals (part of Takeda Pharmaceuticals) and Seattle Genetics.
Adcetris has been approved for marketing as a lymphoma treatment in over 65 countries, including by the U.S.
How Adcetris works
Lymphoma is a type of blood cancer, caused by abnormal growth and survival of immune cells (called lymphocytes). The cancerous lymphocytes can rapidly multiply, move throughout the body, and group to form tumors. The main types of lymphocytes that become cancerous are called T-cells and B-cells.
In sALCL, the T-cells become cancerous. This type of lymphoma is more common in children than adults. HL, on the other hand, is characterized by the presence of a type of B-cell called Reed-Sternberg (RL) cells.
It is a monoclonal antibody, a protein designed to bind to a specific target, attached to a substance called monomethyl auristatin E (MMAE). The antibody part specifically targets a protein called CD30 that is found on the outside of the lymphoma cancer cells. Once bound to CD30, Adcetris is taken inside the cell where the MMAE part stops it from dividing and producing more cancer cells. Through this mechanism, Adcetris should reduce the number of CD30-positive cancerous cells in the body.
Adcetris in clinical trials
It was approved by the U.S. Food and Drug Administration (FDA) on August 19, 2011, and by the EC on October 31, 2012, for the treatment of CD30-positive HL that has relapsed following autologous stem cell transplant, as well as the treatment of sALCL. It has been extensively studied in multiple clinical trials.
The decision to approve Adcetris for HL was based on the preliminary results of a key Phase 2 clinical trial (NCT00848926). The full results of the five-year study have been published in the scientific journal, Blood.
The trial followed 102 patients with HL treated with Adcetris over a five-year period. The overall survival after five years was 41 percent, with a progression-free survival of 22 percent. During the study, 38 patients (33 percent of all patients) achieved complete remission, with no symptoms of cancer for a while. In patients who achieved complete remission, the five-year overall survival was 64 percent and progression-free survival was 52 percent. This is markedly better than previously available treatments, where the median survival was 1.3 years.
The key clinical trial that led to the approval of Adcetris for the treatment of sALCL, was an open-label Phase 2 study (NCT00866047) in 58 patients. The results, published in the Journal of Clinical Oncology, showed that 57 percent of patients went into complete remission following Adcetris treatment.
The EC revised the Adcetris label in January 2016, to approve retreatment with Adcetris following a relapse. This was based on results from a Phase 2 clinical trial (NCT00947856) testing the efficacy and safety of Adcetris in lymphoma patients who had previously responded to treatment. In total, 21 HL and eight sALCL patients were retreated with Adcetris. The results, published in the Journal of Hematology and Oncology suggested that retreatment with Adcetris had a similar safety profile to previous trials. A response was seen in 68 percent of patients, with 39 percent achieving complete remission again.
Adcetris can cause a number of side effects including numbness/tingling in fingers and toes, nausea, vomiting, fatigue, diarrhea, high temperature, rashes, constipation, infections, allergic reaction, headache, back and muscle pain, loss of appetite, and breathing problems.
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