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Adcetris improves PFS in CD30-expressing peripheral T-cell lymphoma
A phase 3 trial designed to assess the addition of brentuximab vedotin to frontline chemotherapy for patients with CD30-expressing peripheral T-cell lymphoma met its primary endpoint of PFS, according to the agents’ manufacturers.
The randomized phase 3 ECHELON-2 trial also showed significant improvement in all key secondary endpoints, including OS.
Brentuximab vedotin (Adcetris; Seattle Genetics, Takeda) is an antibody-drug conjugate directed at CD30.
The double-blind, multicenter ECHELON-2 trial was designed to enroll 450 patients with CD30-expressing peripheral T-cell lymphoma, an aggressive type of non-Hodgkin lymphoma also known as mature T-cell lymphoma. Approximately 4,000 patients are diagnosed with the disease each year.
Researchers randomly assigned patients to brentuximab vedotin plus CHP chemotherapy — which consists of cyclophosphamide, doxorubicin and prednisone — or CHOP chemotherapy alone. CHOP — a standard treatment for frontline peripheral T-cell lymphoma — consists of cyclophosphamide, doxorubicin, vincristine and prednisone.
Patients assigned the brentuximab vedotin-containing regimen achieved significantly longer PFS as assessed by independent review facility (HR = 0.71; P = 0.011). The brentuximab vedotin-containing regimen also appeared associated with significantly improved OS (HR = 0.66; P = .0244), complete remission rate and objective response rate.
The safety profile of brentuximab vedotin appeared comparable to CHOP and also was consistent with what had been observed in prior studies of the agent in combination with chemotherapy.
Additional results from the ECHELON-2 study will be presented at this year’s ASH Annual Meeting and Exposition, scheduled for Dec. 1-4 in San Diego.
Brentuximab vedotin already is approved as IV infusion for five indications, including three for classical Hodgkin lymphoma, one for systemic anaplastic large cell lymphoma, and one for patients with primary cutaneous anaplastic large cell lymphoma or CD30-expressing mycosis fungoides.
“We are excited about the groundbreaking results of the phase 3 ECHELON-2 clinical trial,” Clay Siegall, PhD, president and CEO of Seattle Genetics, said in a company-issued press release. “We look forward to presenting results at the ASH annual meeting in December and intend to submit a supplemental biologics license application to the FDA for approval in this setting in the near future.”