Celgene's Revlimid combo meets Phase 3 goal in relapsed/refractory indolent lymphoma

Celgene has lifted the curtain on new Phase 3 data for its combo of Revlimid (lenalidomide) plus rituximab (R2) in the treatment of relapsed/refractory follicular and marginal zone lymphoma, confirming that its primary endpoint was met.

Specifically, Celgene confirmed that the combination demonstrated a “highly statistically significant improvement” in progression-free survival in patients compared to placebo, as well as a favourable trend in overall survival rates. Follow-up studies will hope to find that this trend continues when more mature data is gathered.

“Indolent non-Hodgkin lymphomas, such as follicular lymphoma and marginal zone lymphoma, are diseases of underlying immune dysfunction with a need for new options beyond currently available therapies,” explained Dr Jay Backstrom, Chief Medical Officer for Celgene. “We are encouraged by the highly significant improvement in progression-free survival observed in this study and look forward to engaging with regulatory authorities as soon as possible. The R2 regimen represents a potentially new chemotherapy-free option for these patients.”

Celgene confirmed that full data from the trial findings will be presented at an upcoming medical meeting, while global regulatory submissions are planned to be made in the first quarter of 2019.

Matt Fellows