On December 7, 2018 Celgene Corporation (NASDAQ: CELG) reported results from the Phase 3 AUGMENT study, showing that REVLIMID (lenalidomide) in combination with rituximab (R 2 ) has resulted in a progression-free survival (PFS) higher in patients with relapsing / refractory indolent lymphoma than patients treated with rituximab plus placebo (R-placebo) (Press release, Celgene, DEC 7, 2018, View Source [SID1234531952]). The data were presented by John Leonard during an oral presentation at the 60th annual meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper), which took place in San Diego, California.

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The international randomized, double-blind phase 3 clinical study evaluated the efficacy and safety of the experimental combination of R 2 compared to rituximab plus placebo in patients (n = 358) with follicular lymphoma (n = 295) and lymphoma of the area marginal (n = 63) recurrent / refractory. In the study, the R 2 arm demonstrated a statistically significant improvement in the primary progression-free survival endpoint (PFS), assessed by an independent review board, compared to the R-placebo arm. Mean PFS was 39.4 months for patients treated with R 2 versus 14.1 months for patients treated with R-placebo (P <0.0001; HR: 0.46; 95% CI, 0.34-0.62).

«Data from the AUGMENT study, with R 2 more than doubling progression-free survival compared to rituximab monotherapy, represents a possible new and important treatment option for patients with follicular lymphoma or the relapsing / refractory marginal zone» , said John Leonard , researcher responsible for the AUGMENT study, The Richard T. Silver Distinguished Professor of Hematology and Medical Oncology and Director of the Joint Clinical Trials Office at Weill Cornell Medicine, who also served as a consultant for Celgene.

Overall survival (OS), a secondary endpoint, showed a positive trend in terms of improvement in the R 2 arm compared to the control arm (lethal events: 16 vs 26) (HR: 0.61; 95% CI, 0, 33 to 1.13). The two-year OS rate was 93% for patients treated with R 2 and 87% for patients treated with R-placebo.

The overall response rate (ORR), another secondary endpoint, was 78% (n = 138) in the R 2 arm compared to 53% (n = 96) of the R-placebo arm, according to the independent review committee. The duration of the response (DoR) was significantly increased for R 2 compared to R-placebo with medial 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 R 2 arm was neutropenia (58%), vs. 22% in the R-placebo arm. Other AEs commonly seen in more than 20% of patients included diarrhea (31% in the R 2 arm vs. 23% in the R-placebo arm), constipation (26% vs. 14%, respectively), cough (23% vs. 17% ) and fatigue (22% vs. 18%). Adverse events most commonly reported (> 10%) in the R arm 2 were neutropenia, constipation, leukopenia, anemia, thrombocytopenia and acute exacerbation of symptoms tumor ( tumor flare reaction) . During the AUGMENT study no unexpected results were observed in terms of safety.

"These data represent a new, potential treatment strategy for patients with relapsing / relapsing indolent non-Hodgkin’s lymphomas , " said Celgene’s president of Global Clinical Development, Alise Reicin . "We are anticipating the submission of authorization applications for the first quarter of 2019. to allow patients to access this important combination as soon as possible . "

The use of REVLIMID , alone or in combination with other agents, is currently not approved in any country in the treatment of follicular lymphoma or in that of marginal zone lymphoma.

Information on REVLIMID

REVLIMID (lenalidomide) in combination with dexamethasone (des) is indicated for the treatment of patients with multiple myeloma (MM).

REVLIMID is indicated as maintenance therapy in patients with MM following autologous hematopoietic stem cell transplantation (auto-HSCT).

REVLIMID is indicated in the treatment of patients with transfusion-dependent anemia due to myelodysplastic syndromes (MDS) at low or intermediate risk 1, associated with a cytogenetic abnormality with 5q deletion, with or without further cytogenetic abnormalities.

REVLIMID is indicated for the treatment of patients with recurrent mantle cell lymphoma (MCL) or with progression of the disease after 2 previous therapies, one of which includes bortezomib.

REVLIMID is not recommended or recommended for the treatment of patients with chronic lymphatic leukemia (LLC) outside of controlled clinical trials.