Early analysis of the Phase II multiple myeloma (MM) study, in which half of the 60 patients with relapsed MM received combined low-dose dexamethasone with pomalidomide, showed that 76% of the patients experienced disease improvement or stabilization.
Another key finding showed a 29% response rate among patients who previously did not respond to Revlimid therapy. Objective response was achieved by 58% of patients. Approximately eight of the 60 patients had dose reductions. 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 2mg of pomalidomide with or without prednisone.
Approximately, 35% of the treated pomalidomide patients experienced blood cell transfusion independence. Fifteen 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 company said.
Jerome Zeldis, chief medical officer of Celgene, said: The interest in our next immunomodulatory drug 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. Based on these findings and others, Celgene will be developing pomalidomide for relapsed multiple myeloma and other hematological conditions.