Nivolumab and sorafenib in hepatocellular carcinoma: lessons from the CheckMate 459 study
Mené dans 22 pays sur 743 patients atteints d'un carcinome hépatocellulaire de stade avancé (durées médianes de suivi : 15,2 et 13,4 mois), cet essai de phase III compare l'efficacité, du point de vue de la survie globale, et la toxicité du nivolumab et du sorafénib en traitement de première ligne
The increasing number of new options in each line of systemic treatment for hepatocellularcarcinoma is associated with the challenge of how to extrapolate the clinical trialsresults into clinical practice. The design of the multicentre, phase 3 CheckMate 459 trial, comparing nivolumab withsorafenib in patients with advanced hepatocellular carcinoma, was precise and robust,but it produced negative results, with no differences in overall survival (primaryoutcome; p=0·075) or progression-free survival. The authors suggest that these negative results could derive from the high proportionof patients treated with sorafenib who received immuno-oncology agents after discontinuingthe study drug. Any further hypothesis to explain the results would be speculation.However, the CheckMate 459 study has some lessons that can be readily identified bythe scientific community.
The Lancet Oncology , 2021