Abbisko to Present Phase 2 Irpagratinib Data at 2025 ESMO GI Congress

Abbisko Therapeutics Co., Ltd.today announced that updated results from the phase 2 study of irpagratinib (ABSK011) in combination with atezolizumab for the treatment of 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 regimen's favorable safety and promising anti-tumor activity in both treatment-naive and previously treated FGF19+ HCC patients. The evident objective response rate (ORR) and progression free survival (PFS) benefit underscores the potential of irpagratinib-based combinations in the treatment of HCC.

Event Details:

Session: Mini Oral session - Innovation in GI cancers
Presentation Format: Oral Presentation

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 About Irpagratinib (ABSK-011)

Irpagratinib is a highly-selective FGFR4 small molecule inhibitor designed to target overexpression of the FGF19 signaling pathway. Several epidemiological studies indicate that approximately 30% of HCC patients worldwide exhibit FGF19 overexpression. Development of targeted therapies against FGFR4 represent an innovative and novel approach to the treatment of HCC.

To date, no FGFR4 inhibitor has been granted regulatory approval globally. According to Frost & Sullivan, irpagratinib is expected to become the first breakthrough treatment for the treatment of aHCC patients with FGF19 overexpression.

In addition to monotherapy, Abbisko Therapeutics is exploring irpagratinib in combination with atezolizumab, an anti-PD-L1 antibody manufactured by F. Hoffmann-La Roche and Roche (China), in a Phase II study. 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.

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