Pivotal Phase II study data of romidepsin in relapsed PTCL presented at ASH 2010

Dec 6 2010

Celgene International Sàrl (Nasdaq:CELG) today announced that data from a pivotal Phase II, multicenter, international, open-label study of romidepsin (ISTODAX^®) in progressive or relapsed PTCL following prior systemic therapy were presented at the 52^nd American Society of Hematology Annual Meeting.

In the study, patients with histopathologically confirmed PTCL who failed or were refractory to prior systemic therapy received 14 mg/m² of ISTODAX as a four-hour infusion on days 1, 8 and 15 of a 28-day cycle for up to six cycles. Treatment could be extended for response or stable disease.

Of 130 patients with histopathologically confirmed PTCL in the study, the overall response rate was 26% (34/130), as assessed by an Independent Review Committee (IRC) using the International Workshop Criteria. Thirteen percent (17/130) of patients achieved a complete response - the primary endpoint of the study - and another 13% (17/130) achieved a partial response. The median duration of response for all patients who responded was 12 months (range 1-801+ days). The median duration of response for patients who achieved a complete response has not been reached (median duration of follow-up: 8.2 months), and 82% (14/17) of patients with a complete response had not progressed as of the data cut-off for the IRC evaluation (March 31, 2010).

Toxicities associated with ISTODAX^® in the study were as follows: 96.2% (126/131) of patients evaluable for safety experienced at least one treatment-emergent adverse event, with the most common grade 3 or higher adverse events reported as thrombocytopenia (24% 31/131), neutropenia (20% 26/131), infections (17% 22/131) and anaemia (10% 13/131).

Romidepsin (ISTODAX) is not approved as a treatment in progressive or relapsed PTCL.