2025 ESMO GI | 和誉医药将口头汇报依帕戈替尼与阿替利珠单抗联用治疗晚期肝细胞癌的最新临床II期试验数据

2025年6月26号，和誉医药（港交所代码：02256）宣布，公司将在2025年欧洲肿瘤内科学会胃肠道肿瘤大会(ESMO GI)上口头汇报其自主研发的高选择性小分子FGFR4抑制剂依帕戈替尼 (Irpagratinib/ABSK-011) 与阿替利珠单抗联用治疗FGF19过表达晚期肝细胞癌患者的最新2期临床试验数据。此次ESMO GI大会将于当地时间2025年7月2日至5日在西班牙巴塞罗那举行。

和誉医药在此次ESMO GI大会上口头报告信息如下:

标题：依帕戈替尼（ABSK-011）联合阿替利珠单抗用于一线及既往接受过免疫检查点抑制剂治疗的FGF19过表达晚期肝细胞癌患者的2期研究ABSK-011-201的更新结果

报告形式：口头汇报

专场：迷你口头报告环节——胃肠肿瘤创新疗法

报告编号：149MO

报告人：程琪

报告厅：巴塞罗那厅

结论：

在2025年ESMO GI大会上，和誉医药公布了依帕戈替尼（irpagratinib）联合阿替利珠单抗治疗FGF19过表达肝细胞癌（HCC）患者的最新临床试验结果。数据显示，在220 mg每日两次（BID）的剂量组中，客观缓解率（ORR）≥50%，中位无进展生存期（PFS）≥7个月。这些结果表明，这种新型联合疗法在治疗预后较差且可能对基于免疫检查点抑制剂（ICI）的一线标准治疗（SOC）反应不佳的FGF19过表达HCC患者中表现出显著的疗效。

鉴于该研究中展现出的卓越疗效，和誉医药计划启动临床试验，探索依帕戈替尼在ICI治疗和未经治疗患者中的双重或三重联合治疗方案。和誉医药致力于推进依帕戈替尼的联合治疗策略，以更好地应对肝细胞癌治疗的挑战，并为患者带来新的希望。公司将继续在这一领域开展进一步的研究和创新。

背景介绍：

肝细胞癌（HCC）是最常见的原发性肝癌，是全球第六大常见癌症和第三大死亡原因。 FGF19-FGFR4 信号通路失调约占 HCC 的 30%，并在驱动 HCC 肿瘤发生中发挥关键作用。 Irpagratinib是一款高活性高选择性的 FGFR4 抑制剂，有成为同类第一或者同类最佳的潜力。

和誉医药在2024年欧洲肿瘤学会（ESMO）年会上发布了Irpagratinib单药治疗晚期肝细胞癌患者的最新I期临床数据，在接受BID治疗的FGF19过表达的后线HCC病人中观察到44.8%的客观缓解率，展示了极强的抗肿瘤活性。

为进一步发掘Irpagratinib的治疗潜力，和誉医药也在中国内地针对FGF19过表达的晚期HCC患者开展了依帕戈替尼联合抗PD-L1抗体阿替利珠单抗的II期试验，进一步探索联合治疗的疗效。在2024年ESMO-GI大会上，和誉医药发布了联合用药治疗aHCC患者的最新临床试验数据，其中，依帕戈替尼220mg BID联用阿替利珠单抗队列在既往接受过 ICI 治疗的 FGF19+ HCC 患者中实现了 50% 的客观缓解率 (ORR)。

Abbisko Therapeutics to Present Updated Results from the Phase 2 Study of Irpagratinib in Combination with Atezolizumab for the Treatment of Advanced Hepatocellular Carcinoma at the 2025 ESMO GI Congress

26 June 2025, Shanghai – Abbisko Therapeutics Co., Ltd. (Abbisko Therapeutics 02256.HK) today announced that updated results from the phase 2 study of irpagratinib (ABSK-011) in combination with atezolizumab for the treatment of patients with advanced hepatocellular carcinoma (HCC) will be presented at the 2025 ESMO GI Congress, taking place in Barcelona, Spain from July 2 to July 5.

The oral presentation will highlight the safety and efficacy of irpagratinib in combination with atezolizumab in both treatment-naive and previously treated FGF19+ HCC patients. The treatment combination with irpagratinib showcases an objective response rate (ORR) of ≥50% and a median progression-free survival (PFS) of ≥7 months. These results further demonstrate the clinical benefit of irpagratinib in both previously treated and treatment-naive settings, offering renewed hope for patients with advanced hepatocellular carcinoma.

Event Details:

Title: Irpagratinib (ABSK-011) plus Atezolizumab in First-line (1L) and Immune Checkpoint Inhibitors (ICIs) Treated Advanced Hepatocellular Carcinoma (HCC) with FGF19 Overexpression (+): Updated Results of the Phase 2 ABSK-011-201 Study

Presentation Format: Oral Presentation

Session: Mini Oral session - Innovation in GI cancers

Presentation number: 149MO

Presenter: Qi Cheng

Date: July 2, 2025

Room: Barcelona

Summary:

At the 2025 ESMO GI Congress, Abbisko Therapeutics unveiled updated clinical trial results for the combination of irpagratinib and atezolizumab in patients with FGF19 overexpression hepatocellular carcinoma (HCC). The treatment combination with irpagratinib showcases an objective response rate (ORR) of ≥50% and a median progression-free survival (PFS) of ≥7 months in the 220 mg BID cohort. These findings highlight the efficacy of this novel combination therapy in treating HCC patients with FGF19 overexpression, a subgroup of patients typically associated with poorer prognosis and less sensitivity to first-line standard-of-care (SOC) treatments, such as immune checkpoint inhibitors (ICIs).

Abbisko plans to initiate clinical trials exploring dual and triple combination therapies with irpagratinib in both previously ICI-treated and treatment-naïve patient populations. Abbisko remains committed to advancing combination strategies involving irpagratinib to better address the challenges of HCC and bring renewed hope to patients, and will continue conducting research in this disease area.

Background:

Hepatocellular carcinoma (HCC) is the most common type of primary liver cancer and ranks as the sixth most prevalent cancer and third leading cause of death worldwide. Dysregulation of FGF19-FGFR4 signaling accounts for approximately 30% of HCC and plays a pivotal role in driving HCC tumorigenesis. Irpagratinib is a highly potent and selective FGFR4 inhibitor, with potential to become a first-in-class or best-in-class FGFR4 inhibitor. Abbisko Therapeutics previously presented phase I clinical data of irpagratinib at the 2024 ESMO Annual Meeting, demonstrating promising anti-tumor activity as a single agent with an ORR of 44.8% in FGF19 overexpressed late-line HCC patients.

To further explore the therapeutic potential of irpagratinib, Abbisko is conducting a phase 2 clinical trial of irpagratinib in combination with atezolizumab. This trial is investigating irpagratinib in combination with atezolizumab, a PD-L1 antibody, in FGF19+ advanced HCC patients.At the previous 2024 ESMO GI Congress, Abbisko presented clinical data demonstrating 220mg irpagratinib BID in combination with atezolizumab achieved a 50% objective response rate (ORR) in FGF19+ HCC patients who had previously received immune checkpoint inhibition therapy.

关于和誉

和誉医药（香港联交所代码：02256）成立于2016年，是一家立足中国，着眼全球的创新药研发公司。公司的创始人和管理团队拥有多年顶尖跨国药企的研发和管理经验，并参与了多个临床及上市新药的研发。和誉医药专注于肿瘤新药研发，以小分子肿瘤精准治疗和小分子肿瘤免疫治疗药物为核心，着眼病患及医药市场的需求，秉承国际新药开发的理念和标准，致力于开发新颖及高潜力药物靶点的潜在first-in-class或best-in-class创新药物，用于改善中国及全球病人的生活质量。自成立以来，和誉医药已经建立了丰富的创新产品管线，涵盖肿瘤精准治疗领域以及肿瘤免疫治疗领域。

更多信息，欢迎访问 www.abbisko.com。