Celgene announced results of the phase 3 AUGMENT study, which showed that REVLIMID in combination with rituximab demonstrated superior progression-free survival in patients with relapsed/refractory indolent lymphoma compared to patients who received rituximab plus placebo. The data were at the 60th American Society of Hematology Annual Meeting and Exposition.The phase 3 randomized, double-blind, international clinical study evaluated the efficacy and safety of the investigational combination of R2 versus rituximab plus placebo in patients with relapsed/refractory follicular and marginal zone lymphoma. In the study, the R2 arm demonstrated a highly statistically significant improvement in the primary endpoint of progression-free survival, evaluated by an independent review committee, versus the R-placebo arm. The median PFS was 39.4 months for patients treated with R2 and 14.1 months for those treated with R-placebo. Overall survival, a secondary endpoint, showed a positive trend for improvement in the R2 arm vs. the control arm. Two-year OS rate was 93% for patients receiving R2 and 87% for those receiving R-placebo. Overall response rate, another secondary endpoint, was 78% in the R2 arm vs. 53% in the R-placebo arm, according to the independent review committee. Duration of response was significantly improved for R2 vs. R-placebo with median DoR of 37 vs. 22 months, respectively. The most frequent adverse event in the R2 arm was neutropenia, vs. 22% in the R-placebo arm. No unexpected safety findings were observed in the AUGMENT trial. REVLIMID alone or in combination with other agents is not approved for use in follicular lymphoma or marginal zone lymphoma in any geography.
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