Randomized Phase II and Biomarker Study of Pembrolizumab plus Bevacizumab versus Pembrolizumab Alone for Patients with Recurrent Glioblastoma.

Clinical Cancer Research : an Official Journal of the American Association for Cancer Research
Lakshmi NayakDavid A Reardon

Abstract

VEGF is upregulated in glioblastoma and may contribute to immunosuppression. We performed a phase II study of pembrolizumab alone or with bevacizumab in recurrent glioblastoma. Eighty bevacizumab-naïve patients with recurrent glioblastoma were randomized to pembrolizumab with bevacizumab (cohort A, n = 50) or pembrolizumab monotherapy (cohort B, n = 30). The primary endpoint was 6-month progression-free survival (PFS-6). Assessed biomarkers included evaluation of tumor programmed death-ligand 1 expression, tumor-infiltrating lymphocyte density, immune activation gene expression signature, and plasma cytokines. The neurologic assessment in neuro-oncology (NANO) scale was used to prospectively assess neurologic function. Pembrolizumab alone or with bevacizumab was well tolerated but of limited benefit. For cohort A, PFS-6 was 26.0% [95% confidence interval (CI), 16.3-41.5], median overall survival (OS) was 8.8 months (95% CI, 7.7-14.2), objective response rate (ORR) was 20%, and median duration of response was 48 weeks. For cohort B, PFS-6 was 6.7% (95% CI, 1.7-25.4), median OS was 10.3 months (95% CI, 8.5-12.5), and ORR was 0%. Tumor immune markers were not associated with OS, but worsened OS correlated with baseline dexamethaso...Continue Reading

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Citations

Feb 6, 2021·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Balint OtvosJustin D Lathia
Apr 4, 2021·Journal of Clinical Medicine·Pasquale PersicoMatteo Simonelli
Jun 1, 2021·Frontiers in Immunology·Miranda W Yu, Daniela F Quail
Aug 5, 2021·Neuro-oncology Advances·Sith SathornsumeteePornsuk Cheunsuchon
Oct 3, 2021·Journal of Neuro-oncology·Eudocia Q Lee
Sep 18, 2021·Neuropathology and Applied Neurobiology·Gayaththri Vimalathas, Bjarne Winther Kristensen

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