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.