Phase 2 study of Revlimid for the treatment of non-Hodgkin's lymphoma (NHL)
Celgene announced Phase 2 clinical data results from two investigational studies evaluating the combination of Revlimid (lenalidomide) plus Rituxan (rituximab, from Genentech) for the treatment of indolent non-Hodgkin's lymphoma (NHL). In the first study, treatment with lenalidomide and low-dose dexamethasone plus rituximab was evaluated in patients with relapsed or refractory indolent B-cell lymphoma or mantle cell lymphoma previously resistant to rituximab. The study demonstrated an average 58% (14/24) overall response rate (ORR), with median follow-up of 13.3 months (3.1-28.8). Responses by specific cancer subtype ranged from 67% (2/3) ORR in patients with small lymphocytic lymphoma, 60% (9/15) ORR in patients with follicular lymphoma, and 60% (3/5) ORR in patients with mantle cell lymphoma.
In the second study, the combination of lenalidomide and rituximab was evaluated in patients with relapsed or refractory indolent NHL with measurable disease who had received at least one prior therapy. Of the 17 patients evaluable for response, the ORR was 76% (13/17), which included 41% of patients (7/17) with a CR and 35% (6/17) patients with a PR. Additionally, 11% (2/17) of patients had stable disease. At a median follow-up of 25 months, the median progression-free survival (PFS) for all evaluable patients was 12.4 months.
Revlimid is an immunomodulator already indicated for the treatment of multiple myeloma (in combination with dexamethasone) in patients who have received at least one prior therapy. Revlimid is also approved for the treatment of transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality.
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