Phase III AUGMENT trial positive results for Revlimid + rituximab to treat follicular (n=295) and marginal zone (n=63) lymphoma. Celgene.

Celgene Corporation announced results of the phase III AUGMENT study, which showed that Revlimid (lenalidomide) in combination with rituximab (R2) demonstrated superior progression-free survival (PFS) in patients with relapsed/refractory indolent lymphoma compared to patients who received rituximab plus placebo (R-placebo). The data were presented by John Leonard, M.D. in an oral presentation at the 60th American Society of Hematology (ASH) Annual Meeting and Exposition in San Diego, C.A. (Abstract #445). The phase III randomized, double-blind, international clinical study evaluated the efficacy and safety of the investigational combination of R2 versus rituximab plus placebo in patients (n=358) with relapsed/refractory follicular (n=295) and marginal zone (n=63) lymphoma.

In the study, the R2 arm demonstrated a highly statistically significant improvement in the primary endpoint of progression-free survival (PFS), evaluated by an independent review committee, versus (vs.) 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 (P <0.0001; hr: 0.46 95 ci 0.34-0.62.>

�The AUGMENT data, with R2 more than doubling progression-free survival over rituximab monotherapy, represents an important potential new treatment option for patients with relapsed/refractory follicular or marginal zone lymphoma,� said John Leonard, M.D., AUGMENT lead investigator, The Richard T. Silver Distinguished Professor of Hematology and Medical Oncology and director of the Joint Clinical Trials Office at Weill Cornell Medicine, who has also served as a consultant for Celgene.

< p> Overall survival (OS), a secondary endpoint, showed a positive trend for improvement in the R2 arm vs. the control arm (16 vs. 26 death events) (HR: 0.61; 95% CI, 0.33-1.13). Two-year OS rate was 93% for patients receiving R2 and 87% for those receiving R-placebo. Overall response rate (ORR), another secondary endpoint, was 78% (n=138) in the R2 arm vs. 53% (n=96) in the R-placebo arm, according to the independent review committee. Duration of response (DoR) was significantly improved for R2 vs. R-placebo with median DoR of 37 vs. 22 months, respectively (P =0.0015; HR: 0.53; 95% CI, 0.36-0.79). The most frequent adverse event (AE) in the R2 arm was neutropenia (58%), vs. 22% in the R-placebo arm. Additional commonly observed AEs in more than 20% of patients included diarrhea (31% in the R2 arm vs. 23% in R-placebo), constipation (26% vs. 14%, respectively), cough (23% vs. 17%), and fatigue (22% vs. 18%), respectively. Adverse events that were reported at a higher rate (>10%) in the R2 arm were neutropenia, constipation, leukopenia, anemia, thrombocytopenia and tumor flare. No unexpected safety findings were observed in the AUGMENT trial.

These data represent a potential new treatment strategy for patients with relapsed/refractory indolent non-Hodgkin�s lymphomas,� said Alise Reicin, M.D., President, Global Clinical Development for Celgene. �We are advancing regulatory submissions in the first quarter of 2019 to bring this important combination to patients as soon as possible.�