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Thursday, September 5, 2019

Bristol-Myers’ Opdivo fails to achieve PFS endpoint in late-stage brain cancer study

Bristol-Myers Squibb (NYSE:BMYannounces that its Phase 3 CheckMate-548 study evaluating the addition of Opdivo (nivolumab) to standard-of-care treatment of radiation therapy and chemo agent temozolomide in patients with newly diagnosed glioblastoma multiforme (GBM) that is O6-methylguanine-DNA methyltransferase-methylated failed to demonstrate a statistically valid increase in progression-free survival (PFS), one of the two primary endpoints.
Overall survival (OS), the other primary endpoint, has not yet matured.
The independent Data Monitoring Committee has recommended that the trial continue as planned.
The estimated primary completion date is February 2022.

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