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Bristol-Myers Squibb to Continue Phase III Opdivo Study in Glioblastoma Despite PFS Setback

NEW YORK – Bristol-Myers Squibb announced that although a Phase III trial involving nivolumab (Opdivo) and chemoradiation didn't meet its primary endpoint of progression-free survival in patients with MGMT methylated brain cancer, the study will continue to assess if the treatment extends survival.  

BMS' CheckMate-548 is a 700-patient trial randomizing those with MGMT-methylated, newly diagnosed glioblastoma multiforme to treatment either with nivolumab with temozolomide and radiation, or just chemoradiation. The primary endpoints are progression-free survival assessed by blinded, independent central review and overall survival. 

The study failed to show that nivolumab plus chemoradiation significantly improves progression-free survival compared to the standard of care in MGMT-methylated brain cancer patients. However, based on the advice of the data monitoring board, BMS will continue the study, recognizing that glioblastoma is a difficult-to-treat disease with limited options. "We look forward to seeing the overall survival data when they are available," Fouad Namouni, head of BMS oncology development, said in a statement.   

Less than five percent of glioblastoma patients live for five years following diagnosis. Although few drugs have been shown to impact survival in this setting, studies suggest that MGMT methylation may predict which patients respond to treatment.