Try our mobile app

Six-Year Overall Survival Results Added to U.S. Prescribing Information for ADCETRIS® (brentuximab vedotin) as First-Line Treatment for Advanced Hodgkin Lymphoma

Published: 2023-06-15 00:31:00 ET
<<<  go to SGEN company page

– Update based on statistically significant 41% reduction in risk of death vs. previous standard of care in patients with frontline advanced classical Hodgkin lymphoma –

– First and only targeted therapy inclusive regimen to improve overall survival in this setting –

BOTHELL, Wash.--(BUSINESS WIRE)-- Seagen Inc. (NASDAQ: SGEN) today announced an update to the U.S. Prescribing Information (PI) for ADCETRIS® (brentuximab vedotin) to include six-year overall survival results from the phase 3 ECHELON-1 clinical trial of ADCETRIS plus combination chemotherapy in patients with previously untreated Stage III or IV classical Hodgkin lymphoma compared to chemotherapy alone. The statistically significant data were presented last year at the annual meetings of the American Society of Clinical Oncology and the European Hematology Association.

ADCETRIS was approved for advanced Hodgkin lymphoma in 2018 based on an improvement in progression-free survival in combination with chemotherapy agents AVD (Adriamycin [doxorubicin], vinblastine and dacarbazine) in the ECHELON-1 trial. Since its first approval in 2011, more than 113,000 patients have received ADCETRIS worldwide.

“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,” said David Epstein, Chief Executive Officer, Seagen. “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.”

At a median follow up of approximately six years (73 months) in the ECHELON-1 study, the ADCETRIS combination with AVD resulted in a statistically significant 41% reduction in risk of death versus previous standard of care chemotherapy agents ABVD (Adriamycin [doxorubicin], bleomycin, vinblastine, and dacarbazine) (hazard ratio [HR] 0.59; 95% confidence interval [CI]: 0.396, 0.879) (p-value = 0.009). National treatment guidelines last year designated ADCETRIS in combination with AVD as a preferred standard of care for the disease based on the overall survival data.i

Also included in the revised PI are updated data for peripheral neuropathy at about six years. Among patients who experienced peripheral neuropathy, 72% had complete resolution, 14% had partial improvement, and 14% had no improvement. The median time to partial improvement was 2.9 months (range