New trial results have been published showing that a combination of Celgene's Revlimid and Roche's rituximab (R2) significantly extended progression-free survival in patients with relapsed or refractory indolent lymphoma, compared to rituximab with placebo.
According to data from the Phase III Augment trial, published in The Journal of Clinical Oncology, R2 significantly extended progression-free survival by up to 25 weeks.
It also found that the combination regimen reduced the risk of disease progression or death by 54% compared with Rituxan alone.
The US Food and Drug Administration (FDA) has already granted a priority review for the combination on the back of these results, with an action date of June 27 this year.
The trial enrolled 358 patients from 97 centres in 15 different countries; 24% of participants had three or more prior systemic treatments, and 117 (33%) had experienced relapse or progression within two years of the initial diagnosis.
Patients with indolent non-Hodgkin lymphoma typically respond well to first-line immunochemotherapy, however at relapse, single-agent rituximab is commonly administered. The above results show that lenalidomide could increase the activity of rituximab, resulting in more efficient treatment.