A Pilot Study of Pembrolizumab in Combination With Y90 Radioembolization in Subjects With Poor Prognosis Hepatocellular Carcinoma

Shawn Yu; Menggang Yu; Barry Keane; David M Mauro; Paul R Helft; William P Harris; Hanna K Sanoff; Matthew S Johnson; Bert O'Neil; Autumn Jackson McRee; Ashwin Somasundaram

doi:10.1093/oncolo/oyad331

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A Pilot Study of Pembrolizumab in Combination With Y90 Radioembolization in Subjects With Poor Prognosis Hepatocellular Carcinoma

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A Pilot Study of Pembrolizumab in Combination With Y90 Radioembolization in Subjects With Poor Prognosis Hepatocellular Carcinoma

Shawn Yu, Menggang Yu, Barry Keane, David M Mauro, Paul R Helft, William P Harris, Hanna K Sanoff, Matthew S Johnson, Bert O'Neil, Autumn Jackson McRee, …

The oncologist (Dayton, Ohio), Vol.29(3), pp.270-e413

03/01/2024

DOI: 10.1093/oncolo/oyad331

PMID: 38325328

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Abstract

Combination checkpoint inhibition therapy with yttrium-90 (Y90) radioembolization represents an emerging area of interest in the treatment of advanced hepatocellular carcinoma (HCC). HCRN GI15-225 is an open-label, single-arm multicenter, pilot study (NCT03099564). Eligible patients had poor prognosis, localized HCC defined as having portal vein thrombus, multifocal disease, and/or diffuse disease that were not eligible for liver transplant or surgical resection. Patients received pembrolizumab 200 mg intravenously every 3 weeks in conjunction with glass yttrium-90 (Y90) radioembolization TheraSphere. Primary endpoint was 6-month progression-free survival (PFS6) per RECIST 1.1. Secondary endpoints included time to progression (TTP), objective response rate (ORR), overall survival (OS), and safety/tolerability. Between October 23, 2017 and November 24, 2020, 29 patients were enrolled: 2 were excluded per protocol. Fifteen of the remaining 27 patients were free of progression at 6 months (55.6%; 95% CI, 35.3-74.5) with median PFS 9.95 months (95% CI, 4.14-15.24) and OS 27.30 months (95% CI, 10.15-39.52). One patient was not evaluable for response due to death; among the remaining 26 patients, ORR was 30.8% (95% CI, 14.3-51.8) and DCR was 84.6% (95% CI, 65.1-95.6). In patients with localized, poor prognosis HCC, pembrolizumab in addition to glass Y90 radioembolization demonstrated promising efficacy and safety consistent with prior observations (ClinicalTrials.gov Identifier: NCT03099564; IRB Approved: 16-3255 approved July 12, 2016).

Antibodies, Monoclonal, Humanized

Carcinoma, Hepatocellular - drug therapy

Carcinoma, Hepatocellular - radiotherapy

Humans

Liver Neoplasms - drug therapy

Liver Neoplasms - radiotherapy

Pilot Projects

Progression-Free Survival

Treatment Outcome

Yttrium Radioisotopes

Details

Title: Subtitle: A Pilot Study of Pembrolizumab in Combination With Y90 Radioembolization in Subjects With Poor Prognosis Hepatocellular Carcinoma
Creators: Shawn Yu - University of North Carolina at Chapel Hill
Menggang Yu - University of Michigan
Barry Keane - University of North Carolina at Chapel Hill
David M Mauro - University of North Carolina at Chapel Hill
Paul R Helft - Indiana University Health
William P Harris - University of Washington
Hanna K Sanoff - University of North Carolina at Chapel Hill
Matthew S Johnson - Indiana University – Purdue University Indianapolis
Bert O'Neil - Community Health Network, Indianapolis, IN, USA
Autumn Jackson McRee - Janssen (United States)
Ashwin Somasundaram - University of North Carolina at Chapel Hill
Resource Type: Journal article
Publication Details: The oncologist (Dayton, Ohio), Vol.29(3), pp.270-e413
DOI: 10.1093/oncolo/oyad331
PMID: 38325328
NLM abbreviation: Oncologist
ISSN: 1083-7159
eISSN: 1549-490X
Grant note: T32 GM086330 / NIGMS NIH HHS K08 CA259342 / NCI NIH HHS
Language: English
Date published: 03/01/2024
Academic Unit: Internal Medicine
Record Identifier: 9985177946502771

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