Celgene International Sàrl (NASDAQ:CELG) today announced that initial data from an investigator-initiated study of REVLIMID (lenalidomide) plus Rituxan (rituximab) in patients with newly diagnosed indolent B-cell non-Hodgkin's lymphoma (NHL) were presented at the annual meeting of the American Society of Clinical Oncology.
Patients in the study had previously untreated indolent NHL with stage III or IV measurable (>1.5 cm) disease. Of 30 patients for whom FLIPI (Follicular Lymphoma International Prognostic Index) scores were available, 87% of patients were classified as either intermediate or high risk, and 73% of patients had positive bone marrow involvement. Patients were treated with 20 mg/day of lenalidomide on days 1-21 of a 28-day cycle and 375 mg/m2 of rituximab on day 1 of each cycle for up to 6 cycles.
Results from the Phase II single-arm study reported that of 45 evaluable patients, the overall response rate was 89% (40/45), with 73% (33/45) of patients achieving a complete response (defined as CR or CRu). In a subset of 29 evaluable patients with follicular lymphoma, 97% (28/29) responded to therapy, including 86% (25/29) of patients who achieved a complete response. At a median follow-up of 12 months (range, 3-20), one patient has progressed.
The most common grade 3 or 4 adverse events experienced by patients in the study were neutropaenia (21% 10/45), rash (13% 6/45), and myalgia (8% 4/45). The rash was generally found to be self-limited and usually did not occur on re-exposure to the drug. Three patients were removed from treatment due to an adverse event related to one or both of the study drugs but were eligible for toxicity assessment and included 1 with rash and 1 with arterial thrombosis, both of which occurred during cycle 1. The third patient developed a severe reaction to rituximab prior to lenalidomide dosing during cycle 2.
These data are from an investigational study. REVLIMID® does not have marketing approval for the treatment of patients with untreated indolent B-cell NHL.
Celgene International Sàrl