Dr Gerhard Held speaks to ecancer about the interim analysis of the Niveau trial which is an international, randomised phase 3 study of the AGMT, GLA, HOVON, Lysa and PLRG.
The objective of this study was to evaluate the efficacy and safety of nivolumab added to R-GemOx in patients with R/R LBCL after 1 prior line of therapy not eligible for HDCT/HSCT owing to age and/or comorbidities.
The study found that the addition of nivolumab to R-GemOx and subsequent maintenance with nivolumab did not improve progression-free survival. However, there was a trend towards improved overall survival, suggesting that nivolumab may enhance the efficacy of subsequent therapies.
The study is ongoing with a final analysis scheduled after completion of follow-up.