Adding Adcetris (brentuximab vedotin) to standard chemotherapy significantly lengthens the time it takes for Hodgkin’s lymphoma to progress, or for a patient to die, according to an updated of Phase 3 clinical trial results.
The latest findings of the ongoing ECHELON-1 trial (NCT01712490) apply to newly diagnosed advanced classical Hodgkin’s.
Researchers conducted the study under a Special Protocol Assessment agreement with the U.S. Food and Drug Administration that is aimed at accelerating the agency’s approval. The European Medicines Agency offered scientific advice on the process, Takeda and Seattle Genetics added.
“We are excited about the positive result, which shows a statistically significant improvement in the primary” modified trial objective of increasing the time before a patient’s disease progresses, Dr. Dirk Huebner, head of Takeda’s Oncology Therapeutic Area Unit, said in a press release. “The results of this trial signify an important step forward in the development of Adcetris and have the potential to change the treatment approach of frontline advanced Hodgkin lymphoma.”
Adcetris is a drug-conjugated antibody. It works by having a toxic compound bind to an antibody that targets a cancer protein, in this case the CD30 receptor. When the drug binds to the CD30 protein in cancer cells, the toxic payload is delivered specifically to these cells, leaving healthy cells unharmed.
So far, regulators have approved Adcetris only as a consolidation treatment for stem cell transplants that doctors perform in Hodgkin’s patients at high risk of their disease relapsing or progressing. A consolidation therapy makes a transplant go better.
ECHELON-1 is now assessing the safety and effectiveness of using Adcetris as a first-line treatment in combination with a standard of care chemotherapy — either Adriamycin, vinblastine, dacarbazine, or AVD. The controls in the study are receiving chemotherapy alone.
The study is being conducted at research centers in North America, Europe, South America, Australia, Asia, and Africa. The 1,334 patients who were enrolled had Stage 3 or 4 classical Hodgkin’s lymphoma and had yet to receive chemotherapy or radiation.
Two years after they were treated, 82 percent of those who received Adcetris and standard of care chemotherapy were alive and disease free, compared with 77 percent in the control arm. This significant improvement in disease-progression-free survival met the study’s primary objective.
Preliminary results of the combo’s impact on patients’ overall survival, a secondary objective of the study, also look good, researchers said. The team is continuing to assess secondary objectives, however.
The safety of the Adcetris and AVD combo is in line with the safety profiles of the two components individually, researchers said.
“The outcome of the Phase 3 ECHELON-1 trial represents a significant milestone for the Hodgkin lymphoma community,” said Dr. Clay Siegall, president and chief executive officer of Seattle Genetics. “Seattle Genetics’ goal is to establish Adcetris as the foundation of care for CD30-expressing lymphomas, including Hodgkin lymphoma. Notably, this is the first clinical trial in frontline advanced Hodgkin lymphoma to show superior efficacy of a regimen that eliminates [the chemotherapy] bleomycin.”
Takeda and Seattle Genetics said the trial results should support a request that regulators approve Adcetris as a first-line of therapy for advanced Hodgkin’s lymphoma.
The companies hope to present the results at the American Society of Hematology annual meeting in Atlanta, Dec. 9-12.