50% ORR: Impressive Clinical Trial Data for Irpagratinib Combined with Atezolizumab in Advanced Hepatocellular Carcinoma Stuns ESMO-GI Congress

SHANGHAI, June 27, 2024 /PRNewswire/ -- Abbisko Therapeutics Co., Ltd. (Abbisko Therapeutics) announced that it has presented new phase II clinical data of its highly selective FGFR4 inhibitor irpagratinib (ABSK011) in combination with atezolizumab for the treatment of advanced hepatocellular carcinoma（HCC）at the 2024 ESMO-GI Congress. The presentation highlights that 220mg BID of irpagratinib in combination with atezolizumab demonstrated promising antitumor activity with an objective response rate (ORR) of 50% in FGF19+ HCC patients.

ESMO-GI, a world-renowned gastrointestinal oncology conference, is being held in Munich, Germany, from June 26 to 29, 2024.

Abbisko presentations at ESMO-GI 2024:

Title: A Phase 2 Study of Irpagratinib (ABSK-011) plus Atezolizumab in Patients with Advanced Hepatocellular Carcinoma (HCC)
Poster display number：171P
Poster display session: Hepatocellular and non-biliary liver cancer
Poster display date and time: 27 June 2024, 15:35-16:30 PM (UTC+1)

Summary:

At the 2024 ESMO-GI conference, Abbisko Therapeutics debuted new clinical trial results with the combination of irpagratinib and atezolizumab. In HCC patients with FGF19 overexpression, the objective response rate (ORR) was 50% (5/10)in the 220 mg BID cohort, demonstrating this novel combination therapy has notable benefits in enhancing the ORR. Notably, strong efficacy and good safety were also observed in patients who had previously received immune checkpoint inhibitor (ICI) therapy, providing further evidence that targeting FGF19-FGFR4 may provide a much-needed differentiated treatment option for HCC.

Given the encouraging preliminary results from this study, Abbisko plans to explore dual/triple combinations with irpagratinib in earlier lines of therapy for HCC. Abbisko continues to look forward to combination approaches with irpagratinib to better address HCC and bring hope to patients, with aims to conduct further research and innovation in this 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 clinical data from its first-in-human study of irpagratinib at the 2023 ESMO Annual Meeting, demonstrating promising anti-tumor activity as a single agent with an ORR of 40.7% 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, to understand safety and efficacy.

About Abbisko

Founded in April 2016, Abbisko Therapeutics Co., Ltd., (Stock Code on the Hong Kong Stock Exchange: 2256.HK), is an oncology-focused

biopharmaceutical company founded in Shanghai, dedicated to the discovery and development of innovative medicines that treat unmet medical needs in China and globally. The Company was established by a group of seasoned drug hunters with rich R&D and managerial expertise from top multinational pharmaceutical companies. Since its founding, Abbisko has built an extensive pipeline of 16 innovative small molecule programs focused on precision oncology and immuno-oncology.

For more information, please visit www.abbisko.com.

SOURCE Abbisko