Date: 2014-12-09
Type of information: Presentation of results at a congress
phase: 1,2
Announcement: presentation of results at the 56th American Society of Hematology (ASH) Annual Meeting and Exposition, being held December 6-9 in San Francisco, CA
Company: Celgene (USA - NJ)
Product: Istodax® (romidepsin) combined with cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP)
Action mechanism:
Disease: peripheral t-cell lymphoma
Therapeutic area: Cancer - Oncology
Country:
Trial details:
Latest
news: * On December 9, 2014, Celgene announced that data were presented from a phase 1b/2 study of Istodax® (romidepsin) combined with cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) in patients with peripheral t-cell lymphoma were presented during the 56th American Society of Hematology annual meeting. In the phase Ib and phase II portions of this study, presented by Jehan Dupuis, M.D. (from the Lymphoma Study Association or LYSA), a total of 37 patients were treated with romidepsin at varying doses plus CHOP. Based on results from phase I (n=18), the recommended dose of romidepsin for the phase II portion was 12 mg/m2 (n= 19). Two patients had an early cardiac event (myocardial infarction) and were excluded from the efficacy analysis. A third patient had a cardiac event (acute cardiac failure) during the first cycle and continued on CHOP alone. Fifty-one percent of patients (18/35) in the study achieved a complete response, with 17% (6/35) achieving a partial response and 26% (9/35) having progressive disease. With a median follow-up of 30 months, median PFS is 21.3 months with 21 patients having progressed. The most common grade 3-4 hematologic adverse events were neutropenia (85%), thrombocytopenia (35%) and anemia (8%). The most common grade 3-4 non-hematologic adverse events (AE) were febrile neutropenia (19%), general physical health deterioration (13%), hypophosphatemia (10.8%) and vomiting (10%). There were no deaths attributable to toxicity. “Based on this study, the combination of romidepsin and CHOP shows potential for the treatment of patients with PTCL, and supports further study through the phase III comparison of RO-CHOP and CHOP alone in this area of disease,” said Bertrand Coiffier, M.D., Ph.D., lead investigator of the study (Richard Delarue M.D. is co investigator).
