BOUDRY, Switzerland--(December 10, 2008)--Celgene International Sarl (Nasdaq: CELG) today announced that its next IMiDs compound, pomalidomide, has shown promising activity with manageable safety and tolerability for the treatment of relapsed/refractory multiple myeloma (MM) and myelofibrosis. The data were presented at the 50th Annual American Society of Hematology meeting in San Francisco, CA.
Early analysis of the Phase II MM study, in which half of the 60 patients with relapsed MM received combined low-dose dexamethasone with pomalidomide, showed that 76 percent of the patients experienced disease improvement or stabilization. Another key finding showed a 29 percent response rate among patients who previously did not respond to REVLIMID® therapy. Objective response was achieved by 58 percent of patients. Eight of the 60 patients had dose reductions. The most commonly occurring major adverse events were neutropenia (32%), thrombocytopenia (3%) and anemia (3%). Investigators concluded that for most patients, pomalidomide plus low-dose dexamethasone was generally well tolerated with manageable adverse events. However, there was one patient death due to pneumonia while neutropenic in this refractory, pre-treated population.
The study's conclusion was that pomalidomide was highly active in this segment of multiple myeloma patients.
The second Phase II trial, evaluating 84 patients with advanced myelofibrosis with myeloid metaplasia, was a four-arm blinded adaptive design trial. The study evaluated two different doses of pomalidomide with or without prednisone, with a prednisone-only arm as a control. All but one patient had failed prior therapies. The Grade 2 or greater side effects were infrequent and comparable to the prednisone control except for thrombocytopenia that was experienced in one of 22 patients and one of 19 patients treated with 2 mg of pomalidomide with or without prednisone. Thirty-five percent of the treated pomalidomide patients experienced blood cell transfusion independence. At the time of this presentation, 15 of the 16 responders remain in remission. Granulocytopenia and normal spleen size correlated with response, but the percent of abnormal cytogenetics and the presence of a JAK2 mutation did not.
"The interest in our next IMiDs compound, pomalidomide, by the hematological community was demonstrated by both clinical abstracts being selected for oral presentations at the annual meeting of the American Society of Hematology," stated Jerome B. Zeldis, Chief Medical Officer, Celgene Corporation. "Based on these findings and others, Celgene will be developing pomalidomide for relapsed multiple myeloma and other hematological conditions."
Source: Celgene International Sàrl