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Nivolumab plus radiotherapy with or without temozolomide in newly diagnosed glioblastoma: Results from exploratory phase I cohorts of CheckMate 143.

Publication ,  Journal Article
Omuro, A; Reardon, DA; Sampson, JH; Baehring, J; Sahebjam, S; Cloughesy, TF; Chalamandaris, A-G; Potter, V; Butowski, N; Lim, M
Published in: Neurooncol Adv
2022

BACKGROUND: The phase 1 cohorts (1c+1d) of CheckMate 143 (NCT02017717) evaluated the safety/tolerability and efficacy of nivolumab plus radiotherapy (RT) ± temozolomide (TMZ) in newly diagnosed glioblastoma. METHODS: In total, 136 patients were enrolled. In part A (safety lead-in), 31 patients (n = 15, methylated/unknown MGMT promoter; n = 16, unmethylated MGMT promoter) received nivolumab and RT+TMZ (NIVO+RT+TMZ) and 30 patients with unmethylated MGMT promoter received NIVO+RT. In part B (expansion), patients with unmethylated MGMT promoter were randomized to NIVO+RT+TMZ (n = 29) or NIVO+RT (n = 30). Primary endpoint was safety/tolerability; secondary endpoint was overall survival (OS). RESULTS: NIVO+RT±TMZ was tolerable; grade 3/4 treatment-related adverse events occurred in 51.6% (NIVO+RT+TMZ) and 30.0% (NIVO+RT) of patients in part A and 46.4% (NIVO+RT+TMZ) and 28.6% (NIVO+RT) in part B. No new safety signals were detected. In part A, median OS (mOS) with NIVO+RT+TMZ was 33.38 months (95% CI, 16.2 to not estimable) in patients with methylated MGMT promoter. In patients with unmethylated MGMT promoter, mOS was 16.49 months (12.94-22.08) with NIVO+RT+TMZ and 14.41 months (12.55-17.31) with NIVO+RT. In part B, mOS was 14.75 months (10.01-18.6) with NIVO+RT+TMZ and 13.96 months (10.81-18.14) with NIVO+RT in patients with unmethylated MGMT promoter. CONCLUSIONS: CheckMate 143 was the first trial evaluating immune checkpoint inhibition with first-line treatment of glioblastoma. Results showed that NIVO can be safely combined with RT±TMZ, with no new safety signals. Toxicities, including lymphopenia, were more frequent with NIVO+RT+TMZ. OS was similar with or without TMZ in patients with unmethylated MGMT promoter, and differences by MGMT methylation status were observed.

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Published In

Neurooncol Adv

DOI

EISSN

2632-2498

Publication Date

2022

Volume

4

Issue

1

Start / End Page

vdac025

Location

England
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Omuro, A., Reardon, D. A., Sampson, J. H., Baehring, J., Sahebjam, S., Cloughesy, T. F., … Lim, M. (2022). Nivolumab plus radiotherapy with or without temozolomide in newly diagnosed glioblastoma: Results from exploratory phase I cohorts of CheckMate 143. Neurooncol Adv, 4(1), vdac025. https://doi.org/10.1093/noajnl/vdac025
Omuro, Antonio, David A. Reardon, John H. Sampson, Joachim Baehring, Solmaz Sahebjam, Timothy F. Cloughesy, Alexandros-Georgios Chalamandaris, Von Potter, Nicholas Butowski, and Michael Lim. “Nivolumab plus radiotherapy with or without temozolomide in newly diagnosed glioblastoma: Results from exploratory phase I cohorts of CheckMate 143.Neurooncol Adv 4, no. 1 (2022): vdac025. https://doi.org/10.1093/noajnl/vdac025.
Omuro A, Reardon DA, Sampson JH, Baehring J, Sahebjam S, Cloughesy TF, et al. Nivolumab plus radiotherapy with or without temozolomide in newly diagnosed glioblastoma: Results from exploratory phase I cohorts of CheckMate 143. Neurooncol Adv. 2022;4(1):vdac025.
Omuro, Antonio, et al. “Nivolumab plus radiotherapy with or without temozolomide in newly diagnosed glioblastoma: Results from exploratory phase I cohorts of CheckMate 143.Neurooncol Adv, vol. 4, no. 1, 2022, p. vdac025. Pubmed, doi:10.1093/noajnl/vdac025.
Omuro A, Reardon DA, Sampson JH, Baehring J, Sahebjam S, Cloughesy TF, Chalamandaris A-G, Potter V, Butowski N, Lim M. Nivolumab plus radiotherapy with or without temozolomide in newly diagnosed glioblastoma: Results from exploratory phase I cohorts of CheckMate 143. Neurooncol Adv. 2022;4(1):vdac025.

Published In

Neurooncol Adv

DOI

EISSN

2632-2498

Publication Date

2022

Volume

4

Issue

1

Start / End Page

vdac025

Location

England