Phase 2 study of pembrolizumab in patients with recurrent and residual high-grade meningiomas

Priscilla K. Brastianos (), Albert E. Kim, Anita Giobbie-Hurder, Eudocia Quant Lee, Nancy Wang, April F. Eichler, Ugonma Chukwueke, Deborah A. Forst, Isabel C. Arrillaga-Romany, Jorg Dietrich, Zachary Corbin, Jennifer Moliterno, Joachim Baehring, Michael White, Kevin W. Lou, Juliana Larson, Magali A. Sauvage, Kathryn Evancic, Joana Mora, Naema Nayyar, Jay Loeffler, Kevin Oh, Helen A. Shih, William T. Curry, Daniel P. Cahill, Fred G. Barker, Elizabeth R. Gerstner and Sandro Santagata
Additional contact information
Priscilla K. Brastianos: Harvard Medical School
Albert E. Kim: Harvard Medical School
Anita Giobbie-Hurder: Harvard Medical School
Eudocia Quant Lee: Harvard Medical School
Nancy Wang: Harvard Medical School
April F. Eichler: Harvard Medical School
Ugonma Chukwueke: Harvard Medical School
Deborah A. Forst: Harvard Medical School
Isabel C. Arrillaga-Romany: Harvard Medical School
Jorg Dietrich: Harvard Medical School
Zachary Corbin: Smilow Cancer Hospital and Yale Cancer Center, Yale School of Medicine
Jennifer Moliterno: Smilow Cancer Hospital and Yale Cancer Center, Yale School of Medicine
Joachim Baehring: Smilow Cancer Hospital and Yale Cancer Center, Yale School of Medicine
Michael White: University of Rochester, Division of Neuro-Oncology
Kevin W. Lou: Harvard Medical School
Juliana Larson: Harvard Medical School
Magali A. Sauvage: Harvard Medical School
Kathryn Evancic: Harvard Medical School
Joana Mora: Harvard Medical School
Naema Nayyar: Harvard Medical School
Jay Loeffler: Harvard Medical School
Kevin Oh: Harvard Medical School
Helen A. Shih: Harvard Medical School
William T. Curry: Harvard Medical School
Daniel P. Cahill: Harvard Medical School
Fred G. Barker: Harvard Medical School
Elizabeth R. Gerstner: Harvard Medical School
Sandro Santagata: Harvard Medical School

Nature Communications, 2022, vol. 13, issue 1, 1-7

Abstract: Abstract High-grade meningiomas are associated with neuro-cognitive morbidity and have limited treatments. High-grade meningiomas harbor an immunosuppressive tumor microenvironment (TME) and programmed death-ligand 1 (PD-L1) expression may contribute to their aggressive phenotype. Here, we present the results of a single-arm, open-label phase 2 trial (NCT03279692) evaluating the efficacy of pembrolizumab, a PD-1 inhibitor, in a cohort of 25 evaluable patients with recurrent and progressive grade 2 and 3 meningiomas. The primary endpoint is the proportion of patients alive and progression-free at 6 months (PFS-6). Secondary endpoints include progression-free and overall survival, best intracranial response, and toxicity. Our study has met its primary endpoint and achieved a PFS-6 rate of 0.48 (90% exact CI: 0.31–0.66) and a median PFS of 7.6 months (90% CI: 3.4–12.9 months). Twenty percent of patients have experienced one (or more) grade-3 or higher treatment-related adverse events. These results suggest that pembrolizumab exerts promising efficacy on a subset of these tumors. Further studies are needed to identify the biological facets within the meningioma TME that may drive response to immune-based therapies.

Date: 2022
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DOI: 10.1038/s41467-022-29052-7

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