Efficacy and Safety of Durvalumab/Tremelimumab in Unresectable Hepatocellular Carcinoma as Immune Checkpoint Inhibitor Rechallenge Following Atezolizumab/Bevacizumab Treatment.

IF 4.4 3区医学 Q2 ONCOLOGY Targeted Oncology Pub Date : 2024-09-01 Epub Date: 2024-09-02 DOI:10.1007/s11523-024-01092-7

Takuya Sho, Goki Suda, Masatsugu Ohara, Risako Kohya, Takashi Sasaki, Sonoe Yoshida, Shunichi Hosoda, Koji Ogawa, Takashi Kitagataya, Osamu Maehara, Shunsuke Ohnishi, Naoki Kawagishi, Mitsuteru Natsuizaka, Masato Nakai, Masaru Baba, Yoshiya Yamamoto, Yoko Tsukuda, Takashi Meguro, Ren Yamada, Tomoe Kobayashi, Tomofumi Takagi, Naoya Sakamoto

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Abstract

Background: While guidelines recommend immune checkpoint inhibitor (ICI) rechallenge as second-line therapy for unresectable hepatocellular carcinoma (HCC), data supporting this remain limited, particularly regarding a standard regimen for first- and second-line treatments. Tremelimumab/durvalumab was recently approved but data on ICI rechallenge are lacking.

Objectives: The purpose of this study was to evaluate the early efficacy and safety of tremelimumab/durvalumab for HCC as an ICI rechallenge following initial ICI therapy with atezolizumab/bevacizumab.

Patients and methods: This multicenter retrospective study included patients with HCC who underwent treatment with tremelimumab/durvalumab, with relevant available clinical information. We evaluated the safety and efficacy of tremelimumab/durvalumab as ICI rechallenge following initial treatment with atezolizumab/bevacizumab. We analyzed the outcomes in patients who underwent tremelimumab/durvalumab as an ICI rechallenge and those who received tremelimumab/durvalumab as their initial ICI therapy RESULT: A total of 45 patients treated with tremelimumab/durvalumab were included, with 55.6% (25/45) undergoing ICI rechallenge. The objective-response and disease-control rates in patients who underwent ICI rechallenge were 14.3% (3/21) and 47.6% (10/21), respectively, similar to those in patients initially treated with tremelimumab/durvalumab. All patients (n = 3) who experienced the best response to progressive disease (PD) with initial atezolizumab/bevacizumab experienced PD during ICI rechallenge. The incidence rates of adverse events were similar between patient groups treated with tremelimumab/durvalumab as ICI rechallenge and initial ICI. Among patients experiencing immune-related adverse events (irAEs) with atezolizumab/bevacizumab, 75% (3/4) encountered similar irAEs during ICI rechallenge.

Conclusion: Early safety and efficacy profiles of durvalumab/tremelimumab as ICI rechallenge are satisfactory.

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Durvalumab/Tremelimumab作为Atezolizumab/Bevacizumab治疗后免疫检查点抑制剂再挑战治疗不可切除肝细胞癌的有效性和安全性。

背景：虽然指南建议将免疫检查点抑制剂（ICI）再挑战作为不可切除肝细胞癌（HCC）的二线治疗，但支持这一建议的数据仍然有限，特别是关于一线和二线治疗的标准方案。特瑞莫单抗/达伐单抗最近获得批准，但缺乏ICI再治疗的数据：本研究旨在评估曲妥木单抗/杜瓦单抗治疗HCC的早期疗效和安全性，作为阿特珠单抗/贝伐单抗初始ICI治疗后的ICI再挑战：这项多中心回顾性研究纳入了接受曲妥木单抗/杜瓦单抗治疗的HCC患者，并提供了相关的临床信息。我们评估了使用阿特珠单抗/贝伐单抗进行初始治疗后，作为 ICI 再挑战使用曲妥木单抗/杜瓦单抗的安全性和有效性。我们分析了接受曲妥珠单抗/杜瓦单抗作为ICI再治疗的患者和接受曲妥珠单抗/杜瓦单抗作为初始ICI治疗的患者的疗效结果：共纳入45名接受曲妥珠单抗/杜瓦单抗治疗的患者，其中55.6%（25/45）接受了ICI再治疗。接受ICI再挑战的患者的客观反应率和疾病控制率分别为14.3%（3/21）和47.6%（10/21），与最初接受tremelimumab/durvalumab治疗的患者相似。所有最初接受阿特珠单抗/贝伐单抗治疗的患者（n = 3）都在ICI再挑战期间出现了进展性疾病（PD）的最佳反应。接受曲妥珠单抗/杜瓦单抗作为ICI再挑战治疗的患者组与接受初始ICI治疗的患者组之间的不良事件发生率相似。在使用阿特珠单抗/贝伐珠单抗出现免疫相关不良事件（irAEs）的患者中，75%（3/4）的患者在ICI再挑战期间出现了类似的irAEs：结论：durvalumab/tremelimumab作为ICI再治疗的早期安全性和疗效令人满意。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Targeted Oncology 医学-肿瘤学

CiteScore

8.40

自引率

3.70%

发文量

审稿时长

>12 weeks

期刊介绍： Targeted Oncology addresses physicians and scientists committed to oncology and cancer research by providing a programme of articles on molecularly targeted pharmacotherapy in oncology. The journal includes: Original Research Articles on all aspects of molecularly targeted agents for the treatment of cancer, including immune checkpoint inhibitors and related approaches. Comprehensive narrative Review Articles and shorter Leading Articles discussing relevant clinically established as well as emerging agents and pathways. Current Opinion articles that place interesting areas in perspective. Therapy in Practice articles that provide a guide to the optimum management of a condition and highlight practical, clinically relevant considerations and recommendations. Systematic Reviews that use explicit, systematic methods as outlined by the PRISMA statement. Adis Drug Reviews of the properties and place in therapy of both newer and established targeted drugs in oncology.