Researchers present data from Phase II study of lenalidomide in patients with untreated CLL at ASCO

Celgene International Sàrl (NASDAQ:CELG) today announced that researchers presented data from an investigator-initiated Phase II study of lenalidomide (REVLIMID) in untreated patients with chronic lymphocytic leukemia at the annual meeting of the American Society of Clinical Oncology.

Results of the Phase II single-arm study reported that at a median follow-up of 23 months, the overall response rate (OR) for 60 evaluable patients was 62%, and 15% of patients achieved a complete response (CR/CRi). At the median follow-up, median progression-free survival had not been reached and the overall survival rate was 90%.

The most common grade 3 or 4 adverse events reported in the study were neutropenia (38% of cycles), thrombocytopenia (14% of cycles), and anemia (<1% of cycles). Grade 3-4 infections were observed in 15% of patients.

Patients in the study were 65 years or older with untreated CLL and received 5 mg/day of lenalidomide for the first 56 days of treatment and then titrated up to 25 mg/day by 5 mg increments for days 1-21 of each cycle (28 days) as tolerated.

These data are from an investigational study. REVLIMID does not have marketing approval for the treatment of patients with untreated CLL.