Addition of brentuximab vedotin to chemotherapy extends OS in advanced Hodgkin lymphoma
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The addition of brentuximab vedotin to front-line chemotherapy reduced risk for death by 41% among patients with newly diagnosed advanced classical Hodgkin lymphoma, according to topline data released by the agent’s manufacturer.
Brentuximab vedotin (Adcetris, Seagen), an antibody-drug conjugate directed at CD30, exhibited a safety profile consistent with that observed in other studies, results of the randomized phase 3 ECHELON-1 trial showed.
“These groundbreaking results are important for patients with advanced classical Hodgkin lymphoma, given that an improvement in overall survival has rarely been shown in front-line treatment of this disease,” Roger Dansey, MD, chief medical officer for Seagen, said in a company-issued press release. “We look forward to presentation of the results at an upcoming medical meeting.”
Brentuximab vedotin consists of an anti-CD30 monoclonal antibody attached to a microtubule-disrupting agent, monomethyl auristatin E, through a protease-cleavable linker. The agent uses a linker system designed to be stable in the bloodstream but to release monomethyl auristatin E when it internalizes into cells that express CD30, according to the press release.
The open-label ECHELON-1 trial assessed the safety and efficacy of brentuximab vedotin plus doxorubicin, vinblastine and dacarbazine vs. doxorubicin, bleomycin, vinblastine and dacarbazine for adults with stage III or stage IV classical Hodgkin lymphoma.
The investigators randomly assigned 1,334 patients to the brentuximab vedotin combination or the chemotherapy regimen via IV on days 1 and 15 of each 28-day cycle for as many as six cycles.
Modified PF served as the primary endpoint. OS served as a key secondary endpoint.
Median follow-up was approximately 6 years.
Previously released PFS results served as the basis for global regulatory approvals.
The OS analysis showed a statistically significant survival improvement among patients who received brentuximab vedotin in combination with chemotherapy (HR = 0.59; 95% CI, 0.39-0.87).
Brentuximab vedotin is approved in the United States for certain types of relapsed or refractory Hodgkin lymphoma, including treatment-naive stage III/stage IV classical Hodgkin lymphoma and peripheral T-cell lymphoma.
It contains a boxed warning that states progressive multifocal leukoencephalopathy and death resulting from JC virus infection can occur among patients who receive the agent.
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