Abbisko Therapeutics Co. Ltd. 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.

At the 2024 ESMO-GI conference, Abbisko Therapeutics debuted new clinical trial results with the combination of irpagratinab and atezolizumab. In HCC patients with FGF19 overexpression, the objective response rate (ORR). In HCC patients with F GF19 overexpression, the objectives 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 irpagratinab to better address HCC and bring hope to patients, with aims to conduct further research and innovation in this area.

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.ysregulation of FGF19-FGFR 4 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 Therape therape 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 irpagratinim, Abbisko is conducting a phase 2 clinical trial of irpag Ratinib in combination with atezolizumab. This trial is investigating irpagratinibinib in combination with atzolizumab, a PD-L1 antibody, in FGF19+ advanced HCC patients, to understand safety and efficacy.