From Earlier: Results from a Randomized Study of REVLIMID and Rituximab in Patients with Recurrent Follicular Lymphoma Presented at ASCO
Celgene International Sàrl, a subsidiary of Celgene Corporation (NASDAQ: CELG), announced results from a randomized study comparing REVLIMID® (lenalidomide) plus rituximab to lenalidomide monotherapy in previously treated patients with recurrent follicular lymphoma. These data were presented at the 48th American Society of Clinical Oncology Annual Meeting in Chicago, Ill.
Follicular lymphoma is the most common indolent non-Hodgkin's lymphoma and the second most common form of non-Hodgkin's lymphomas.
In the study, patients received either single-agent lenalidomide (15 mg in cycle 1 and 20 mg in cycles 2-12 administered on days 1-21 of each 28-day cycle) (n=45) or lenalidomide (15 mg in cycle 1 and 20 mg in cycles 2-12 administered on days 1-21 of each 28-day cycle) plus rituximab (375 mg/m2 weekly for four weeks in cycle 1) (n=44). A third arm consisting of rituximab as a single-agent was discontinued from the study as a result of low patient accrual.
Of the 89 evaluable patients, the objective response rates were 73% for patients receiving combination therapy, with 36% achieving a complete response, compared to 51% for patients receiving the lenalidomide monotherapy, with 13% achieving a complete response. With a median follow-up of 1.7 years (range 0.1 – 4.1 years), the median event-free survival (EFS) for patients in the combination arm was 2 years (p=0.0063), while patients in the lenalidomide monotherapy arm achieved a median EFS of 1.2 years.
The most common grade 3-4 adverse events for patients receiving lenalidomide plus rituximab and lenalidomide monotherapy, respectively, were neutropenia (19% vs. 16%), fatigue (14% vs. 9%) and thrombosis (4% vs. 16%). The full treatment regimen was completed in 61% of combination and 36% of lenalidomide monotherapy patients, with the difference due to more progressions or non-responders in the lenalidomide monotherapy group. In the combination arm 18% of subjects discontinued therapy early due to AEs compared to 22% in the lenalidomide monotherapy arm.
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