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Nivolumab fails to extend PFS in glioblastoma subset
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A randomized phase 3 trial designed to evaluate the addition of nivolumab to standard therapy for certain patients with newly diagnosed glioblastoma multiforme failed to meet one of its primary endpoints of PFS.
The data monitoring committee recommended the trial continue so data related to OS — the other primary endpoint — can mature.
Nivolumab (Opdivo, Bristol-Myers Squibb) — a PD-1 immune checkpoint inhibitor — is approved in the United States for treatment of several cancers, including certain patients with melanoma, lung cancer, renal cell carcinoma, classical Hodgkin lymphoma, head and neck squamous cell carcinoma or urothelial carcinoma.
The randomized phase 3 CheckMate -548 trial evaluated the addition of nivolumab to temozolomide and radiation therapy for patients with newly diagnosed glioblastoma multiforme that is O6-methylgluanine-DNA methyltransferase (MGMT) methylated. MGMT methylation status is frequently used as a biomarker to predict how patients with glioblastoma will respond to therapy .
PFS as assessed by blinded independent central review and OS served as primary endpoints. Investigator-assessed PFS, as well as OS rate up to 2 years, served as secondary endpoints.
Results showed patients who received nivolumab, temozolomide and radiation therapy derived no significant PFS benefit compared with those who received temozolomide and radiation therapy alone.
“Though CheckMate -548 did not show statistically significant improvement in progression-free survival, we are continuing to evaluate the benefit the addition of Opdivo to the standard-of-care treatment regimen may bring to patients suffering from glioblastoma multiforme, an extremely aggressive and difficult disease to treat,” Fouad Namouni, MD, head of oncology development at Bristol-Myers Squibb, said in a company-issued press release. “We look forward to seeing the overall survival data when they are available.”