US Prescribing Information of Adcetris Updated to Include 6-Year Overall Survival of Hodgkin Lymphoma

Seagan Inc announced an update to the US prescribing information for brentuximab vedotin (Adcetris) to include 6-year overall survival results from the phase 3 ECHELON-1 clinical trial (NCT01712490) of the drug plus combination chemotherapy in those with previously untreated state III or IV classical Hodgkin lymphoma compared to chemotherapy alone.¹

Credit: Vitalii Vodolazskyi - stock.adobe.com

The data were presented last year at the annual meetings of the American Society of Clinical Oncology and the European Hematology Association.¹

“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,” David Epstein, chief executive officer at Seagen, BSPharm, MBA, said in a statement. “The overall survival data are a major step forward in cancer research, and the transformative benefit offered by the [brentuximab vedotin] regimen can profoundly impact the lives of these patients.”¹

In 2018, brentuximab vedotin was approved for advanced Hodgkin lymphoma based on an improvement in progression-free survival (PFS) of 82.3% in combination with chemotherapy agents doxorubicin (Adriamycin), vinblastine, and dacarbazine (AVD), in the ECHELON-1 trial. According to the statement, since the drugs first approval in 2011, more than 113,000 individuals have received brentuximab vedotin worldwide.¹

At the median follow-up of 73 months in the study, brentuximab vedotin in combination with AVD demonstrated a statistically significant 41% reduction in the risk of death compared to the standard of care chemotherapy of doxorubicin, bleomycin, vinblastine, and dacarbazine. Last year, the national treatment guidelines designated brentuximab vedotin in combination with AVD as a preferred standard of care for the disease based on the overall survival (OS) rate of 93.9%.¹

Additionally, the revised prescribing information includes updates about peripheral neuropathy at approximately 6 years. The updated data state that among those 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 and the time to complete resolution was 6.6 months, according to the investigators.¹

Of individuals who had ongoing neuropathy, 57% had grade 1, 30% had grade 2, 12% had grade 3, and less than 1% had grade 4. The safety profile remained consistent with previous studies, and there were no new safety signals observed.¹

The ECHELOn-1 trial included 1224 individuals with previously untreated stage III or IV classical Hodgkin Lymphoma. The trial’s primary endpoint included modified PFS evaluated by an independent review facility. A key secondary endpoint was OS, which included an event-driven, pre-specified, alpha-controlled analysis in the intent-to-treat population, according to the statement.¹

According to the CDC, there were 7861 new cases of Hodgkin lymphoma in the United States with 1011 deaths in 2020. Hodgkin lymphoma spreads from one group of lymph nodes to another group in an orderly way, according to the CDC.

References

1. Six-year overall survival results added to US prescribing information for Adcetris (brentuximab vedotin) as first-line treatment for advanced Hodgkin lymphoma. News release. Seagen. June 14, 2023. Accessed June 16, 2023. https://investor.seagen.com/press-releases/news-details/2023/Six-Year-Overall-Survival-Results-Added-to-U.S.-Prescribing-Information-for-ADCETRIS-brentuximab-vedotin-as-First-Line-Treatment-for-Advanced-Hodgkin-Lymphoma/default.aspx
2. Centers for Disease Control and Prevention. Lymphoma. Updated May 29, 2018. Accessed June 16, 2023. https://www.cdc.gov/cancer/lymphoma/index.h