SUMMIT (dpa-AFX) - Celgene Corp. (CELG) Tuesday said its clinical trial evaluating the combination of REVLIMID with Standard R-CHOP in patients with Diffuse Large B-Cell Lymphoma or DLBCL achieved 98 percent Overall Response Rate and 80 percent Complete Response Rate.
In a phase II, open label, single arm study, of the 64 patients enrolled, 60 were eligible for response evaluation. The primary endpoint was event-free survival with secondary endpoints of progression free survival and overall survival. A one-stage binomial design was used to assess the efficacy and tolerability of REVLIMID with R-CHOP.
The results of this trial support further assessment of this regimen in the sub-type of DLBCL. This would also support a broad phase III program at Celgene, investigating combinations including lenalidomide and rituximab.
Going forward, the company plans to begin enrollment for its phase III study of lenalidomide maintenance compared with placebo following R-CHOP therapy, in the first quarter of 2014. Also, the company's phase III trial evaluating lenalidomide plus R-CHOP21, is planned to start enrollment in the first quarter of 2015.
In follicular lymphoma, the company expects to complete enrollment of RELEVANCE, its phase III study of lenalidomide plus rituximab compared with rituximab plus chemotherapy in patients with previously untreated disease in the second half of 2014.
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