BMS’ CheckMate -548 trial fails to meet one primary endpoint

6th September 2019 (Last Updated December 23rd, 2019 09:32)

Bristol-Myers Squibb (BMS) has reported that the Phase III CheckMate -548 clinical study of an Opdivo (nivolumab) combination in glioblastoma multiforme (GBM) patients has failed to meet the primary endpoint of progression-free survival (PFS).

BMS’ CheckMate -548 trial fails to meet one primary endpoint

Bristol-Myers Squibb (BMS) has reported that the Phase III CheckMate -548 clinical study of an Opdivo (nivolumab) combination in glioblastoma multiforme (GBM) patients has failed to meet the primary endpoint of progression-free survival (PFS).

Opdivo is an immune checkpoint inhibitor of programmed death-1 (PD-1). It uses the body’s immune system to restore immune response against cancer.

The CheckMate -548 trial assessed the combination of Opdivo plus current standard of care comprising temozolomide and radiation therapy compared to standard of care alone.

Newly diagnosed patients with O6-methylguanine-DNA methyltransferase (MGMT)-methylated GBM have been enrolled into the randomised, multi-centre trial.

The trial’s primary endpoints are PFS and overall survival (OS), while secondary endpoints include investigator-assessed PFS and OS up to two years.

“We are continuing to evaluate the benefit of the addition of Opdivo to the standard of care treatment regimen may bring to patients suffering from GBM.”

After the study failed to meet the PFS primary endpoint, the data monitoring committee suggested that it can continue to allow the OS data to mature.

Bristol-Myers Squibb Oncology Development head Fouad Namouni said: “Though CheckMate -548 did not show statistically significant improvement in progression-free survival, we are continuing to evaluate the benefit of the addition of Opdivo to the standard of care treatment regimen may bring to patients suffering from GBM, an extremely aggressive and difficult disease to treat.

“We look forward to seeing the overall survival data when they are available.”

In June, the company announced that Opdivo did not meet the primary endpoint of overall survival in the Phase III CheckMate -459 study, compared to sorafenib, in unresectable hepatocellular carcinoma (HCC) patients.

BMS is developing Opdivo as a monotherapy and combination treatment for a wide range of cancers.

The drug already holds multiple approvals, including for the treatment of metastatic melanoma, non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC) and small cell lung cancer (SCLC).