Phase II study results of pomalidomide, dexamethasone for multiple myeloma presented at ASCO

Celgene International Sàrl (NASDAQ: CELG) today announced results of a Phase II study of pomalidomide and dexamethasone in multiple myeloma patients who have failed both lenalidomide and bortezomib. Data were presented by Dr. Martha Lacy of the Mayo Clinic during the American Society of Clinical Oncology annual meeting.

Patients with multiple myeloma who have progressed after multiple therapies have limited treatment options. Pomalidomide, in an earlier report, demonstrated responses in relapsed multiple myeloma patients refractory to lenalidomide. Patients refractory to bortezomib were not evaluated in the earlier report (Lacy et al. ASH 2009. Abstract #429).

In this current analysis of the study, patients who were refractory to both lenalidomide and bortezomib were given 2mg daily of pomalidomide on days 1-28 of each 28-day cycle and 40mg daily of oral dexamethasone on days 1, 8, 15, 22.

The overall response rate (ORR) for these patients was 54% (19/35). Fourteen percent (5/35) of patients achieved a very good partial response (VGPR), 17% achieved a partial response (PR) (6/35) and 23% achieved a minor response (MR) (8/35). Additionally, at 6-month follow-up, the progression-free survival rate was 58% (95% CI: 42-80) and the overall survival rate was 86% (95% CI 73-100). The median progression-free survival was 8 months (95% CI: NA)

The most common grade 3 or 4 hematologic adverse events were neutropenia (34% 12/35), anemia (9% 3/35) and thrombocytopenia (9% 3/35).

These data are from an investigational study of pomalidomide, which is not approved for marketing.