Nivolumab in glioblastoma multiforme, CheckMate -143 did not meet its primary endpoint of improved overall survival
CheckMate -143, a randomized phase 3 clinical trial evaluating the efficacy and safety of Nivolumab ( Opdivo ) in patients with first recurrence of glioblastoma multiforme ( GBM ), did not meet its primary endpoint of improved overall survival over Bevacizumab ( Avastin ) monotherapy.
Glioblastoma multiforme is a historically difficult disease to treat and conventional treatment options have demonstrated limited responses.
CheckMate -143 was the first randomized clinical trial in glioblastoma multiforme with a PD-1 checkpoint inhibitor.
BMS has two first-line GBM clinical trials, CheckMate -498 and CheckMate -548, evaluating the combination of Nivolumab with radiation therapy with or without Temozolomide in O6-methylguanine-DNA methyltransferase (MGMT)-unmethylated and methylated patients.
Nivolumab is a programmed death-1 ( PD-1 ) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response.
In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world.
In October 2015, the Opdivo and Yervoy combination regimen was the first Immuno-Oncology combination to receive regulatory approval for the treatment of metastatic melanoma. ( Xagena )
Source: BMS, 2017