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Adcetris superior to standard therapy for cutaneous T-cell lymphoma
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Brentuximab vedotin improved outcomes compared with standard therapies among patients with cutaneous T-cell lymphoma, according to study results released by the drug’s manufacturer.
The randomized phase 3 ALCANZA trial included 131 patients with CD30-expressing cutaneous T-cell lymphoma who received prior systemic or radiation therapy.
Researchers assigned patients to single-agent brentuximab vedotin (Adcetris; Seattle Genetics) — an antibody–drug conjugate directed to CD30, expressed on skin lesions of about half of patients with cutaneous T-cell lymphoma — or investigator’s choice of two standard therapies, methotrexate or bexarotene.
A significantly greater percentage of patients assigned brentuximab vedotin achieved objective response lasting at least 4 months (56.3% vs. 12.5%; P < .0001), the study’s primary endpoint.
Key secondary endpoints — including PFS, complete response rate and reduction in symptom burden during treatment — all were statistically significant in favor of brentuximab vedotin, according to a press release.
The drug demonstrated a manageable safety profile, company officials said.
“Cutaneous T-cell lymphoma is a debilitating, disfiguring and painful disease, and there is a significant need for additional effective treatment options with meaningful durable responses,” Clay Siegall, PhD, president and CEO of Seattle Genetics, said in the release. “This is the first phase 3 randomized trial in cutaneous T-cell lymphoma versus an active control to read out, and we are thrilled to have successfully demonstrated the positive impact of using Adcetris for patients enrolled in this study.”
Complete data from the ALCANZA trial will be submitted for presentation at the ASH Annual Meeting and Exposition, which will be held in December in San Diego. A biologics license application seeking approval in this setting likely will be submitted to the FDA in the first half of 2017.
“These remarkable, clinically meaningful results from the completed ALCANZA trial represent an important milestone for the Adcetris program,” Dirk Huebner, MD — executive medical director of the oncology therapeutic area unit at Takeda, which has rights to commercialize brentuximab vedotin outside the United States — said in the press release. “This outcome further establishes our commitment to patients living with CD30-expressing disease, and we look forward to sharing these data with regulatory authorities globally.”
Brentuximab vedotin is approved for treatment of patients with classical Hodgkin lymphoma who failed autologous hematopoietic stem cell transplant (HSCT), as well as those who are not autologous HSCT candidates who failed at least two multiagent chemotherapy regimens.
The agent also is approved for use after autologous HSCT for those with classical Hodgkin lymphoma at high risk for relapse or progression, as well as for treatment of patients with systemic anaplastic large cell lymphoma who failed at least one prior multiagent chemotherapy regimen.