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news.To evaluate the combination of Revlimid and Rituximab in patients with indolent non-hodgkin's lymphoma
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Celgene has presented data for three Phase II studies evaluating combination therapy with Revlimid (lenalidomide) and Rituximab in patients with indolent non-hodgkin’s lymphoma (NHL) during the 51st American Society of Hematology’s annual meeting in New Orleans, LA.
The first study evaluated the Revlimid plus Rituximab combination in patients with relapsed/refractory indolent NHL.
In the first study, all 16 patients had received a median of three prior therapies, which included either Rituximab or Rituximab-containing chemotherapy regimens. In this study, the preliminary overall response rate (ORR) is 75% (12 out of 16 patients), including 31% of patients (n=5) who achieved a complete response. In 13 patients with relapsed or refractory follicular NHL, there were 11 responders (85% ORR), of whom five patients (38%) achieved a complete response.
The second study assessed the effects of extended treatment with Revlimid plus low-dose Dexamethasone with four weekly doses of Rituximab added in cycle 3 in 24 patients with indolent B-cell or mantle cell lymphomas who are resistant to Rituximab.
Among 15 of 24 patients who completed five cycles of therapy by the time of the analysis, the preliminary ORR was 53%, including 33% of patients who achieved a CR. At a median follow-up of 10.9 months, 86% of patients disease had not progressed.
The third study assessed the clinical efficacy and safety of the Revlimd and Rituximab combination in front-line therapy in 30 patients with stage III or IV indolent B-cell NHL. The study reported results for the first 28 patients with NHL subtypes, which included 17 patients with follicular lymphoma, eight patients with marginal zone lymphoma, and three patients with small lymphocytic lymphoma.
The company said that side effects associated with the Revlimid plus Rituximab combination were consistent between the studies evaluating this therapy, and not different from that observed with Revlimid alone. Tumour lysis was not observed in patients who received standard tumour lysis prophylaxis.