by Mathew Shanley for Rare Disease Report
Earlier today, Takeda and Seattle Genetics announced promising results from its Phase 3 ECHELON-1 Clinical Trial that evaluated Adcetris (brentuximab vedotin) in Frontline Advanced Hodgkin Lymphoma.
The randomized trial met its primary endpoint, demonstrating a statistically significant improvement in modified progression-free survival (PFS), and the abstract will be submitted for presentation at the 2017 American Society of Hematology (ASH) Annual Meeting in December 2017.
Hodgkin Lymphoma is a cancer that develops from lymphocytes, or cells in the lymphatic system, that typically help the body fight infection. More than 62,000 people worldwide are diagnosed with the disease every year, and an estimated 25,000 people die from it annually.
Approximately 30% of newly-diagnosed patients do not respond to initial therapy or relapse within the first 2 years, and of those that don’t respond to initial therapy, only 50% will achieve remission.
ECHELON-1 compared the use of a combination of Adcetris + AVD (Adriamycin, vinblastine, dacarbazine) to a recognized standard of care for frontline Hodgkin lymphoma, ABVD (Adriamycin, bleomycin, vinblastine, dacarbazine). The comparison was an effort to determine the effectiveness of both frontline therapy options in patients with previously untreated advanced classical Frontline Hodgkin lymphoma, and the results confirmed that the former resulted in a statistically significant improvement in modified PFS.
“The outcome of the Phase 3 ECHELON-1 trial represents a significant milestone for the Hodgkin lymphoma community,” said Clay Siegall, Ph.D., 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 bleomycin.”
1,334 patients with previously untreated advanced classical Hodgkin lymphoma were enrolled in the trial, and the safety profile of Adcetris+AVD was consistent with that known for the single-agent components of the regimen. Adcetris, an antibody-drug conjugate (ADC), is directed to CD30, a defining marker of classical Hodgkin lymphoma, and not currently approved as a frontline therapy for Hodgkin lymphoma.
“We are excited about the positive result which shows a statistically significant improvement in the primary endpoint of modified PFS,” said Dirk Huebner, M.D., Executive Medical Director, Oncology Therapeutic Area Unit, Takeda Pharmaceutical Company. “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.”
These results will be submitted by Takeda and Seattle Genetics to regulatory authorities for approval in their respective territories.
Earlier this month, the companies announced that data from a Phase 3 clinical trial evaluating the drug in cutaneous T-cell lymphoma (CTCL) patients were published in Lancet.