Seagen has made a significant announcement regarding the updated U.S. Prescribing Information (PI) for Adcetris (brentuximab vedotin). The update includes compelling six-year overall survival data from the Phase III ECHELON-1 clinical trial, which evaluated the efficacy of Adcetris in combination with chemotherapy versus chemotherapy alone in previously untreated Stage III or IV classical Hodgkin lymphoma patients.
The results, presented at prestigious conferences such as the American Society of Clinical Oncology and the European Hematology Association, demonstrated both statistical and clinical significance. After a median follow-up of approximately six years, the Adcetris combination with AVD (Adriamycin, vinblastine, and dacarbazine) showcased an impressive 41% reduction in the risk of death compared to the previous standard chemotherapy regimen ABVD (Adriamycin, bleomycin, vinblastine, and dacarbazine). This remarkable outcome positions Adcetris as a preferred standard of care for the disease, as acknowledged by national treatment guidelines.
In addition to the overall survival data, the revised PI also includes updated information on peripheral neuropathy. Encouragingly, a significant percentage of patients who experienced peripheral neuropathy achieved complete resolution (72%), while others showed partial improvement (14%). The median time to partial improvement was 2.9 months, and the median time to complete resolution was 6.6 months. Among the patients with ongoing neuropathy, the majority exhibited manageable Grade 1 or Grade 2 symptoms.
Importantly, the safety profile of Adcetris in the ECHELON-1 trial remained consistent with previous studies, with no new safety signals identified. This comprehensive update reaffirms the long-term efficacy and safety of Adcetris as a transformative treatment option for advanced Hodgkin lymphoma patients.
“The ultimate goal in cancer research is to offer the best chance for a cure. Patients with advanced classical Hodgkin lymphoma are often young adults with their whole lives ahead of them. The overall survival data are a major step forward in cancer research, and the transformative benefit offered by the ADCETRIS regimen can profoundly impact the lives of these patients.”
– David Epstein, Chief Executive Officer, Seagen
