Responses to romidepsin by line of therapy in patients with relapsed or refractory peripheral T‐cell lymphoma

<jats:title>Abstract</jats:title><jats:p>Peripheral T‐cell lymphoma (<jats:styled-content style="fixed-case">PTCL</jats:styled-content>) is a heterogeneous group of aggressive non‐Hodgkin lymphomas typically associated with poor prognosis. Most patients with <jats:styled-content style="fixed-case">PTCL</jats:styled-content> receive chemotherapy as first‐line treatment, but many experience rapid relapse. For patients with relapsed/refractory <jats:styled-content style="fixed-case">PTCL</jats:styled-content>, responses to treatment and long‐term outcomes tend to worsen with increasing lines of therapy. Romidepsin is a potent class I histone deacetylase inhibitor approved by the <jats:styled-content style="fixed-case">US</jats:styled-content> Food and Drug Administration for the treatment of <jats:styled-content style="fixed-case">PTCL</jats:styled-content> in patients who have received ≥1 prior therapy. A pivotal phase 2 trial of romidepsin in patients with relapsed/refractory <jats:styled-content style="fixed-case">PTCL</jats:styled-content> demonstrated an objective response rate of 25% (33/130), including 15% with confirmed/unconfirmed complete response, and a median duration of response of 28 months. In the analysis presented herein, romidepsin was shown to have similar responses and long‐term outcomes in patients with 1, 2, and ≥3 prior lines of treatment, including in patients with disease refractory to the last prior therapy. Although adverse events increased with increasing lines of treatment, the rate of dose modifications and discontinuations due to adverse events was not significantly different. These data support the use of romidepsin as salvage treatment for <jats:styled-content style="fixed-case">PTCL</jats:styled-content> irrespective of the number of prior therapies.</jats:p>