Complete responses (CR/CRu) on a phase II study of romidepsin in relapsed or refractory peripheral T-cell lymphoma (R/R PTCL).

8033 Background: Potent histone deacetylase inhibitor, romidepsin, has shown durable clinical benefit and tolerability in patients (pts) with R/R PTCL with objective response rates of 38% (17/45, NCI1312) and 26% (34/130, GPI-06-0002) reported in phase II, single-arm, open-label trials. This abstract provides a subset analysis of pts who achieved CR/CRu on the GPI-06-0002 trial. Methods: Pts with R/R PTCL received romidepsin 14 mg/m2 as a 4-h IV infusion on days 1, 8, and 15 every 28 days. An Independent Review Committee made blinded efficacy assessments in a 2-step process: initial radiographic review followed by an overall clinical assessment based on radiology and relevant clinical parameters. Results: The CR/CRu rate was 13% (17/130); median time to CR/CRu was 4 mo (range 2-9 mo). At the data cut-off (March 31, 2010), median duration of response (DOR) was not reached with longest DOR of 26+ mo. With a median follow-up of 8.2 mo, 16/17 (94%) pts had not progressed. Pts who achieved CR/CRu were represen...