USA-headquartered Celgene (Nasdaq: CELG) presented strong data from a Phase II study, conducted by investigators from the MD Anderson Cancer Center in Houston, Texas, evaluating the combination regimen of its blockbuster cancer drug Revlimid (lenalidomide) plus Roche’s Rituxan (rituximab; R2) in untreated, advanced stage, indolent B-cell non-Hodgkin’s lymphomas, at the 11th International Conference on Malignant Lymphoma in Lugano, Switzerland.
Revlimid, which is approved for the treatment of multiple myeloma, generated sales of $2.47 billion last year, up 45% on 2009. The drug does not have marketing approval for the treatment of non-Hodgkin’s lymphoma.
Patients entering the study included 45 with follicular lymphoma (FL), 24 with marginal zone lymphoma and 24 with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The age range was 35 to 84. Patients in the study received 20mg/day of Revlimid on days one to 21, and 375mg/m2 of rituximab on day one of each 28 day cycle for six cycles. The study has been amended to allow patients deriving clinical benefit to remain in the trial for up to 12 cycles. Of the 93 patients who could be evaluated for a response, the overall response rate (ORR) was 91% and the complete response rate (CR) was 65%. Additionally, the 24-month progression-free survival rate was 86%.
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