Celgene has announced positive new data for its leading blockbuster drug, Revlimid (lenalidomide), which earned revenues of $8.2bn in 2017. Data from the Phase III AUGMENT trial assessing Revlimid plus rituximab in relapsed/refractory (R/R) indolent lymphoma was presented during the second day of the 2018 American Society of Hematology (ASH) conference. Within non-Hodgkin’s lymphoma (NHL), Revlimid is currently only FDA-approved to treat one particular subtype, mantle cell lymphoma (MCL), in the third-line setting.

Celgene is conducting various trials to expand this limited approval, and the National Comprehensive Cancer Network (NCCN) guidelines already recommend off-label usage of Revlimid in three other common subtypes of NHL: follicular lymphoma (FL), marginal zone lymphoma (MZL), and diffuse large b-cell lymphoma (DLBCL). FL and MZL are collectively referred to as indolent NHL (iNHL). The Revlimid plus rituximab combination, known as R2, met its primary endpoint of progression-free survival (PFS), doubling the median PFS over the comparator combination of rituximab and placebo.

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Revlimid augment trial results come as ‘relief’

The AUGMENT trial included 358 patients, of which 295 were FL patients and 63 were MZL patients. At a median follow-up of 28.3 months, the median PFS per independent review was 39.4 months with R2 compared to 14.1 months with rituximab alone.

The secondary endpoint of overall survival (OS) also showed a positive trend for improvement in the R2 arm versus control (16 death events versus 26 death events), and the two-year OS rate was 93% versus 87%, respectively.  Adverse events led to treatment discontinuation in 8% of the R2 arm versus 4% in the control arm.

The above results will come as a relief to Celgene, given that the Phase III RELEVANCE trial assessing the R2 regimen in first-line FL failed to meet its primary endpoint earlier this year, striking a blow to Revlimid’s chances of approval in that setting. However, R2 had a more favourable safety profile than rituximab plus chemotherapy, and as such still represents a potential first-line treatment option. In addition, Revlimid is also undergoing two other Phase III label-expansion trials. The ROBUST trial is assessing the agent in a subtype of DLBCL, while MAGNIFY is assessing the R2 regimen followed by Revlimid, versus rituximab maintenance, in R/R FL, MZL, and MCL.

The encouraging AUGMENT results highlight R2 as a chemotherapy-free option for R/R iNHL patients, and have the potential to expand Revlimid’s approved NHL patient pool far beyond its current third-line MCL approval. The R/R FL setting is a crowded market, with various other treatment options available. In terms of where R2 can position itself within this space, the lead study investigator noted that a meaningful percentage of patients are currently treated with rituximab monotherapy, and the positive results from AUGMENT suggest that those patients could instead benefit from the R2 combination.

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