On September 5, Bristol-Myers Squibb announced that the Phase III CheckMate-548 clinical trial evaluating Opdivo for the treatment of glioblastoma multiforme failed to meet its primary endpoint of progression-free survival (PFS). The Data Monitoring Committee recommended that the trial continue as planned to further assess the other primary endpoint, overall survival (OS).
On May 10 this year, BMS also announced that the Phase III CheckMate-498 clinical trial of Opdivo for the treatment of glioblastoma multiforme failed to meet its primary endpoint of overall survival (OS) (see: A Phase III Study of Opdivo in Glioblastoma Fails).
The CheckMate-548 study (NCT02667587) is a randomized, multicenter, Phase III clinical trial designed to evaluate the efficacy and safety of Opdivo in combination with standard therapy (temozolomide plus radiotherapy) versus standard therapy alone in patients with glioblastoma multiforme.
Dr. Fouad Namouni, Head of Oncology Development at Bristol-Myers Squibb (BMS), stated, “Although CheckMate-548 did not demonstrate a statistically significant improvement in progression-free survival, we continue to evaluate the potential benefits of adding Opdivo to the standard of care for patients with glioblastoma (GBM), a highly aggressive and difficult-to-cure disease. We look forward to obtaining the overall survival data.”
Glioblastoma Multiforme (GBM) is the most common and aggressive primary malignant tumor of the central nervous system, with a 5-year survival rate of less than 5%. Approximately 300,000 patients are diagnosed with GBM worldwide each year, and about 240,000 patients die from brain or central nervous system cancers. The standard first-line treatment regimen for GBM patients includes surgery, radiotherapy, and chemotherapy, but therapeutic options remain limited. Temozolomide was approved by the FDA in 2005 as a first-line therapeutic agent for GBM patients.