Phase II study of atezolizumab and bevacizumab combination therapy for patients with advanced hepatocellular carcinoma who previously received systemic treatment.

Authors

null

Takeshi Terashima

Department of Gastroenterology, Kanazawa University Hospital, Kanazawa, Japan

Takeshi Terashima , Tatsuya Yamashita , Makoto Yamamoto , Masahiro Yanagi , Hidetoshi Nakagawa , Akihiro Seki , Kouki Nio , Kuniaki Arai , Tadashi Toyama , Taro Yamashita

Organizations

Department of Gastroenterology, Kanazawa University Hospital, Kanazawa, Japan, Kanazawa University Hospital, Kanazawa, Japan, Innovative Clinical Research Center, Kanazawa University, Kanazawa, Japan

Research Funding

No funding sources reported

Background: Atezolizumab plus bevacizumab (AteBev) has been established as a standard of care for patients with untreated advanced hepatocellular carcinoma (HCC). Lenvatinib was once the first choice and remains a treatment option for such patients; however, no subsequent treatment to date has proven a similar level of efficacy. This study aimed to evaluate the efficacy of AteBev in patients with HCC previously treated with lenvatinib. Methods: In this single-center, open-labeled, single-arm, phase II study, patients with advanced HCC previously treated with at least one systemic treatment were enrolled to receive 1,200 mg of atezolizumab and 15 mg/kg of bevacizumab intravenously every 3 weeks. The primary endpoint was progression-free survival (PFS). Secondary endpoints included overall survival, response rate, tumor control rate, and frequency of adverse events. The threshold and expected PFS were 3 months and 6.8 months, respectively, at a one-sided significance level of 0.05, and statistical power of 80%. Based on these data, the number of patients required was estimated to be 26. Results: Among 29 patients enrolled between November 2020 and October 2022, 26 previously treated with lenvatinib were included in the primary efficacy analysis. Median PFS was 9.70 [90% confidence interval (CI), 5.10–14.24] months. Median overall survival was 17.23 (90% CI, 3.18–27.85) months, and response rate and tumor control rate were 34.6% and 69.2%, respectively. Severe adverse events were observed in six patients (23.1%), six patients (23.1%) discontinued treatment because of immune-related adverse events or treatment-refractory ascites, and 10 patients (38.5%) required the withdrawal of treatment mainly because of proteinuria. There were no treatment-related deaths. Conclusions: AteBev for patients with advanced HCC previously treated with lenvatinib had a comparable efficacy to that in patients with no prior treatment. It may therefore be a treatment option for patients with advanced HCC previously treated with lenvatinib. Clinical trial information: jRCT1041200068.

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Abstract Details

Meeting

2024 ASCO Gastrointestinal Cancers Symposium

Session Type

Poster Session

Session Title

Poster Session B: Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract

Track

Pancreatic Cancer,Hepatobiliary Cancer,Neuroendocrine/Carcinoid,Small Bowel Cancer

Sub Track

Therapeutics

Clinical Trial Registration Number

jRCT1041200068

Citation

J Clin Oncol 42, 2024 (suppl 3; abstr 495)

DOI

10.1200/JCO.2024.42.3_suppl.495

Abstract #

495

Poster Bd #

D2

Abstract Disclosures