European Commission Approves ADCETRIS (brentuximab vedotin) for the Treatment of Adult Patients with Previously Untreated CD30+ Stage III Hodgkin Lymphoma in Combination with AVD
October 23, 2023 – Pharmaceutical – European Commission, Takeda, oncology
· Approval Based on Updated Positive Overall Survival Results from the phase 3 ECHELON-1 Study for Stage III & IV Hodgkin Lymphoma
· First Significant Improvement in Overall Survival in Two Decades in Stage III & IV Hodgkin Lymphoma
· Approval Expands on Six Current Indications for ADCETRIS in the EU
October 18, 2023 — Osaka, Japan and Massachusetts, US — Takeda today announced that the European Commission (EC) approved ADCETRIS (brentuximab vedotin) in combination with doxorubicin, vinblastine and dacarbazine (AVD) to treat adult patients with previously untreated CD30+ Stage III Hodgkin lymphoma. ADCETRIS is an antibody-drug conjugate (ADC) directed at CD30, a defining marker of Hodgkin lymphoma, and has been previously approved as a therapy for adult patients in Europe in six distinct indications, including those with previously untreated CD30+ Stage IV Hodgkin lymphoma. The decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) on 14 September, 2023.
“We are thrilled with the decision of the EC to approve ADCETRIS in combination with chemotherapy as a treatment for adult patients with previously untreated CD30+ Stage III Hodgkin lymphoma, particularly as up to one third of patients with Stage III & IV disease are at risk of experiencing treatment failure with current regimens,” said Awny Farajallah, MD, head of global medical affairs oncology, Takeda. “These patients now have ADCETRIS as a treatment option, and the significant improvement in survival outcomes that ADCETRIS may provide when added to a frontline treatment regimen, as evidenced by the ECHELON-1 clinical trial data.”
The approval is based on the results of the randomised phase 3 ECHELON-1 trial designed to compare ADCETRIS plus AVD to doxorubicin, bleomycin, vinblastine and dacarbazine (ABVD) as a therapy in adult patients with previously untreated Stage III or IV Hodgkin lymphoma. The trial met its primary endpoint of modified progression-free survival (PFS), as well as its key secondary endpoint of overall survival (OS), demonstrating a statistically significant improvement in OS in adult patients with previously untreated Stage III or IV classical Hodgkin lymphoma treated with ADCETRIS+AVD. The safety profile of ADCETRIS was consistent with previous studies, and no new safety signals were observed.
“ECHELON-1 is the first trial to show a statistically significant improvement in overall survival outcomes for adult patients with Stage III & IV Hodgkin lymphoma in two decades, demonstrating the benefit ADCETRIS continues to bring to a broad group of patients,” said John Radford, MD, FMedSci, University of Manchester and the Christie NHS Foundation, lead investigator of the ECHELON-1 trial. “This approval is an exciting advancement in care, allowing even more lymphoma patients to access the proven efficacy, consistent safety and tolerability that ADCETRIS is known to deliver.”
The ECHELON-1 trial, which compared the use of ADCETRIS in combination with AVD to ABVD in 1,334 patients with previously untreated Stage III or IV classical Hodgkin lymphoma, had a primary endpoint of modified PFS per independent review facility (IRF). A key secondary endpoint was OS, which was an event-driven, pre-specified, alpha-controlled analysis in the intention-to-treat population.
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