Pivotal Trial Data Confirm Romidepsin Efficacy in Peripheral T-Cell Lymphoma
(Chemotherapy Advisor) – Romidepsin is active as a single agent in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) across all major subtypes independent of age, sex, type, or number of prior therapies, International Prognostic Index (IPI) score, or prior autologous stem-cell transplantation, according to results published ahead of print in the January 23, 2012 issue of Journal of Clinical Oncology.
Results of the largest clinical trial conducted to date in this population led to the 2011 U.S. Food and Drug Administration approval of romidepsin, a class 1 selective histone deacetylase inhibitor, for the treatment of patients with PTCL following at least one prior therapy. Currently, there is no consensus on standard of care for this patient population.
In this pivotal, open-label, Phase 2 study, romidepsin 14mg/m2 was administered as a 4-hour IV infusion days 1, 8, and 15 every 28 days. Primary end point was rate of complete response/unconfirmed complete response (CR/CRu) by independent review.
Objective response rate was 25% (33 of 130 patients); 15% (19 of 130) had CR/CRu, according to Bertrand Coiffier, MD, Centre Hospitalier Lyon-Sud, Pierre-Bénite, France, and colleagues. Median duration of response was 17 months; the longest response remains ongoing at 34+ months.
Of the 19 patients who achieved CR/CRu, 17 (89%) had not progressed at a median follow-up of 13.4 months. Thrombocytopenia (24%), neutropenia (20%), and infections (all types, 19%) were the most common grade ≥3 adverse events.