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news.Celgene International has reported that clinical data from two ongoing Revlimid studies have demonstrated the drug's activity in relapsed/refractory aggressive non-Hodgkins lymphoma and the need to further evaluate treatment in this critical area of blood disease.
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The initial analysis of the first 46 patients of a 200 patient Phase-II, multi-center open-label clinical study, NHL-003, showed encouraging results that are consistent with those of the earlier NHL-002 trial. Responses were seen across all sub-types of non-Hodgkins lymphoma (NHL). Furthermore, prognostic factors have been identified that may be predictive of response to Revlimid monotherapy. The study reported that overall response to single agent lenalidomide was 28%, with six responses in the diffuse large B-cell lymphoma group (21%) and five in the mantle cell lymphoma group (38%). Ten patients had stable disease (SD), for a tumor control rate (CR, unconfirmed CR, PR or SD) of 50%.
This data validated NHL-002, which showed that tumor burden and time from last dose of rituxumab were demonstrated to be highly significant predictive factors for response of aggressive NHL to lenalidomide monotherapy. In the NHL-002 study overall response rate was 35%, including two complete responses, four complete responses unconfirmed and 11 partial responses. Eleven patients had SD for a tumor control rate of 57%. Median duration of response was 6.2 months and median progression-free survival was 3.7 months.