Ibrutinib—a new standard treatment for relapsed mantle cell lymphoma?
Mené sur 280 patients atteints d'un lymphome à cellules du manteau récidivant ou réfractaire, cet essai randomisé multicentrique de phase III compare l'efficacité, du point de vue de la survie sans progression, et la toxicité de l'ibrutinib et du temsirolimus
In The Lancet, Martin Dreyling and colleagues present the results of a large, international, randomised phase 3 trial comparing the only two drugs approved for previously treated mantle cell lymphoma in Europe: temsirolimus and ibrutinib. Among 280 patients, those randomly assigned to daily oral ibrutinib 560 mg (n=139) showed a significant improvement in progression-free survival, the trial's primary endpoint, compared with patients (n=141) assigned to daily intravenous temsirolimus 175 mg (14·6 months vs 6·2 months; hazard ratio 0·43 [95% CI 0·32–0·58]).
The Lancet , commentaire, 2014