Results From the CheckMate 143 Clinical Trial : Stalemate or New Game Strategy for Glioblastoma Immunotherapy?
Mené sur 369 patients atteints d’un glioblastome récidivant, cet essai de phase III compare l’efficacité, du point de vue de la survie globale, et la toxicité du nivolumab et du bévacizumab (durée médiane de suivi : 9,5 mois)
In this issue of JAMA Oncology, Reardon et al1 report outcomes of the open-label phase 3 CheckMate 143 clinical trial for patients with recurrent glioblastoma randomized to receive nivolumab vs bevacizumab. Nivolumab, a human monoclonal antibody against programmed cell death-1 (PD-1), is an immune checkpoint inhibitor; while bevacizumab, an antibody against vascular endothelial growth factor (VEGF), is an antiangiogenesis agent. Following the results of a promising initial phase 1 safety study,2 CheckMate 143 is the first of a series of phase 3 clinical trials to investigate immune checkpoint inhibitors in patients with primary brain cancer, enrolling patients with first recurrence of glioblastoma after standard resection followed by radiation and temozolomide therapy. At completion of the study,1 the primary end point of median overall survival (mOS) did not differ significantly between the 2 arms: 9.8 months for nivolumab and 10.0 months for bevacizumab. The secondary end points of mean progression-free survival (PFS) and objective response rate (ORR) differed with statistical significance (PFS of 1.5 months for nivolumab and 3.5 months for bevacizumab; and ORR of 7.8% for nivolumab and 23.1% for bevacizumab), both disfavoring the experimental drug. However, importantly, patient response proved more durable for nivolumab (11.1 months) vs bevacizumab (5.3 months).
JAMA Oncology , éditorial, 2019