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Breakthrough Therapy Designation for Brentuximab Vedotin in Front-Line Treatment of Peripheral T-Cell Lymphomas


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THE FDA recently granted Breakthrough Therapy designation to brentuximab vedotin (Adcetris) for previously untreated systemic anaplastic large cell lymphoma or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with cyclophosphamide, doxorubicin, and prednisone (CHP). The results of the phase III ECHELON-2 clinical trial were announced in October 2018, followed by the submission of a supplement biologics licence application to the FDA in November 2018. Additional data were presented at the 2018 ASH Annual Meeting & Exposition.1

Brentuximab vedotin is an antibody-drug conjugate directed to CD30, which is expressed on the surface of several types of PTCL. This Breakthrough Therapy designation was based on data from the phase III ECHELON-2 clinical trial, which evaluated the combination of brentuximab vedotin plus CHP vs the control arm, CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone), in previously untreated CD30-expressing PTCL. The ECHELON-2 study met its primary endpoint, demonstrating a statistically significant improvement in progression-free survival of brentuximab vedotin in combination with CHP vs CHOP, as assessed by an independent review facility (hazard ratio [HR] = 0.71; P = .0110). The brentuximab vedotin plus CHP arm also demonstrated superior overall survival compared with CHOP (HR = 0.66; P = .0244).

All other key secondary endpoints, including progression-free survival in patients with systemic anaplastic large cell lymphoma, complete remission rate, and objective response rate were statistically significantly in favor of the brentuximab vedotin plus CHP arm. The safety profile of brentuximab vedotin plus CHP in the ECHELON-2 trial was comparable to that of CHOP and consistent with the established safety profile of brentuximab vedotin in combination with chemotherapy.

REFERENCE

1. Horwitz SM, O’Connor OA, Pro B, et al: The ECHELON-2 Trial: Results of a randomized, double-blind, active-controlled phase 3 study of brentuximab vedotin and CHP vs CHOP in the frontline treatment of patients with CD30+ peripheral T-cell lymphomas. 2018 ASH Annual Meeting & Exposition. Abstract 997. Presented December 3, 2018.


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