Adding Nivolumab to Standard Care Does Not Improve Survival in Glioblastoma

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Adding nivolumab to the combination of radiotherapy and temozolomide does not appear to improve survival among patients with newly diagnosed glioblastoma with methylated or indeterminate MGMT promoter, according to research presented at the Society for Neuro-Oncology (SNO) 2021 Annual Meeting.

Patients with glioblastoma who receive radiotherapy and temozolomide, the standard of care in this population, frequently relapse, indicating a need for novel therapeutic strategies. This includes patients with methylated MGMT promoter, which is associated with response to temozolomide.

For the phase 3 CheckMate 548 study (ClinicalTrials.gov Identifier: NCT02667587), researchers investigated the safety and efficacy of adding nivolumab to radiotherapy and temozolomide in patients with newly diagnosed glioblastoma with methylated or indeterminate MGMT promoter. The final efficacy and safety analysis from CheckMate 458 were presented by Michael Weller, MD, of the University Hospital and University of Zurich in Switzerland.


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Overall, 716 patients were randomly assigned 1:1 to receive nivolumab plus standard care or placebo plus standard care. Patients were assigned regardless of PD-L1 expression. The primary endpoints were blinded independent central review of progression-free survival (PFS) and overall survival (OS).

At the final analysis, the median PFS was 10.6 months in the nivolumab group and 10.3 months in the placebo group (hazard ratio [HR], 1.06; 95% CI, 0.9-1.25). The median OS was 28.9 months and 32.1 months, respectively (HR, 1.1; 95% CI, 0.91-1.33).

Patients without baseline corticosteroids in the nivolumab group had a median OS of 31.3 months, compared with 33 months for matched patients in the placebo group (HR, 1.12; 95% CI, 0.87-1.43).

Among patients with at least 5% PD-L1 expression, the median PFS was 8.4 months in the nivolumab group and 9.9 months in the placebo group (HR, 1.1; 95% CI, 0.8-1.6). The median OS was 29.2 months and 31.3 months, respectively (HR, 1.0; 95% CI, 0.6-1.4).

Grade 3 to 4 adverse events were noted in 52.4% of patients in the nivolumab group, compared with 33.6% in the placebo group.

“Nivolumab does not work in this indication,” Dr Weller said. “We may have to look to combination trials.”

Disclosures: The CheckMate 548 trial is supported by Bristol Myers Squibb in collaboration with Ono Pharmaceutical Co. Ltd.

Read more of Cancer Therapy Advisor’s coverage of SNO 2021 by visiting the conference page.

Reference

Weller M, Lim M, Idbaih A, et al. A randomized phase 3 study of nivolumab or placebo combined with radiotherapy plus temozolomide in patients with newly diagnosed glioblastoma with methylated MGMT promoter: CheckMate 548. Presented at SNO 2021; November 18-21, 2021. Abstract CTIM-25.



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