50% ORR: Irpagratinib and Atezolizumab Show Promise in Advanced Hepatocellular Carcinoma at ESMO-GI Congress

Abbisko Therapeutics Co., Ltd. (Abbisko Therapeutics) has unveiled new phase II clinical trial results for its selective FGFR4 inhibitor, irpagratinib (ABSK011), in combination with atezolizumab, at the 2024 ESMO-GI Congress in Munich, Germany. The data indicates promising antitumor activity in advanced hepatocellular carcinoma (HCC) patients, particularly in those with FGF19 overexpression.

The conference, held from June 26 to 29, 2024, featured Abbisko’s presentation titled “A Phase 2 Study of Irpagratinib (ABSK-011) plus Atezolizumab in Patients with Advanced Hepatocellular Carcinoma (HCC).” The poster, numbered 171P, was displayed during the Hepatocellular and Non-Biliary Liver Cancer session on June 27.

In the study, the 220 mg BID dosage of irpagratinib combined with atezolizumab achieved an objective response rate (ORR) of 50% in FGF19+ HCC patients, showing significant efficacy in enhancing the ORR. Additionally, the combination demonstrated strong efficacy and a favorable safety profile in patients who had previously undergone immune checkpoint inhibitor (ICI) therapy. These findings suggest that targeting the FGF19-FGFR4 pathway could offer a differentiated treatment option for HCC.

Building on these encouraging preliminary results, Abbisko plans to investigate dual and triple combination therapies with irpagratinib in earlier lines of HCC treatment. The company remains committed to exploring new combination strategies to better address HCC and bring innovative treatments to patients. Future research and innovation in this area are on Abbisko’s agenda.

Hepatocellular carcinoma (HCC) is the most common type of primary liver cancer and ranks as the sixth most prevalent cancer globally, as well as the third leading cause of cancer-related deaths. Dysregulation of the FGF19-FGFR4 signaling pathway is implicated in approximately 30% of HCC cases and plays a crucial role in tumor development.

Irpagratinib is a highly potent and selective FGFR4 inhibitor and has the potential to be a first-in-class or best-in-class therapeutic agent. Previous clinical data presented by Abbisko at the 2023 ESMO Annual Meeting showed promising antitumor activity of irpagratinib as a single agent, with an ORR of 40.7% in late-line HCC patients with FGF19 overexpression.

The ongoing phase II clinical trial seeks to further understand the safety and efficacy of irpagratinib in combination with atezolizumab, a PD-L1 antibody, in patients with advanced HCC expressing FGF19. This combination therapy aims to address the unmet medical needs of HCC patients and improve therapeutic outcomes.

Abbisko Therapeutics, founded in April 2016 in Shanghai, is a biopharmaceutical company focused on oncology. The company has developed an extensive pipeline of 16 innovative small molecule programs targeting precision oncology and immuno-oncology. Established by experienced professionals from leading multinational pharmaceutical companies, Abbisko aims to discover and develop breakthrough medicines to address unmet medical needs in China and globally.