SHANGHAI,Sept. 19,2024 -- Abbisko Therapeutics (HKEX: 02256) is excited to announce the receipt of the ESMO 2024 Best Poster Award on September 16,2024. The award was received for the presentation titled "Updated Safety and Efficacy of Irpagratinib (ABSK011) in advanced hepatocellular carcinoma (aHCC) with FGF19 overexpression from a Phase 1 study". The update data from ABSK-011-101 study showed a tolerable safety profile and promising anti-tumor activity of Irpagratinib monotherapy in aHCC. Of note,in aHCC patients who were pretreated with both immune checkpoint inhibitor (ICI) and Tyrosine Kinase Inhibitor (TKI)—a population with high unmet need in the current treatment paradigm—the observed ORR and DCR was 44.8% and 79.3%,respectively,with a median duration of response (mDoR) of 7.4 months and median progression free survival (mPFS) of 5.5 months.

The poster,#983P,was presented at the Hepatocellular Carcinoma poster session on Sunday,September 16,2024. The Best Poster Award was given at the conclusion of the Sunday Poster Session,with only one recipient being honored in HCC poster session.

2024 ESMO Congress

As of September 5,2024,122 patients have been enrolled,including 74 in the BID cohort with doses consisting of 160mg BID,220mg BID,and 300mg BID. 5.4% of patients were BCLC Stage B,and 89.2% BCLC Stage C,64.9% had a Child-Pugh (CP) Score of 5,27% CP Score of 6,and 6.8% CP Score of 7. 64.9% of patients received multiple lines of prior therapy,85.1% of patients had previously been treated with ICIs,and 75.7% of patients had previously been treated with both ICIs and mTKIs.

The efficacy data show that forty pre-treated HCC patients with FGF19 overexpression were treated with irpagratinib 220 mg BID. Among the 38 evaluable patients,the response rate was 36.8% (14/38),and the disease control rate (DCR) was 78.9% (30/38). The response rate from the subset of patients who had previously received ICI and mTKI therapy was 44.8% (13/29). The longest observed DoR was 16.4 months and the mDoR was 7.4 months. DCR was 79.3% (23/29). mPFS was 5.5 months.

Safety data show one dose-limiting toxicity (DLT) was observed in the 300 mg BID cohort. The most common treatment-related adverse effects (TRAEs,>20%) were ALT elevation,diarrhea,AST elevation,hyperphosphatemia,bilirubin elevation,alkaline phosphatase elevation,platelet decrease,and total bile acid elevation. Grade 3-4 treatment-related adverse events (>5%) included AST elevation,ALT elevation,and diarrhea. No grade 5 adverse events occurred.

HCC is the main type of liver cancer,accounting for 85% to 90% of primary liver cancers. HCCishighlymalignant,about30%ofwhichhaveabnormallyhighFGFR4expressionandapoorprognosis,andtheexistingtreatmentmethodsstillcannotmeetthelong-termsurvivalbenefits. Currently,there is no approved standard of care for HCC patients who have progressed from first-line ICI-based therapies. The FGF19/FGFR4 signaling axis could be a novel therapeutic target for HCC. ABSK-011,a potent FGFR4 inhibitor,demonstrated a tolerable safety profile and promising anti-tumor activity as a single agent. Notably,the irpagratinib 220mg BID regimen exhibited a 44.8% ORR,7.4 months mDoR and 5.5 months mPFS in heavily pre-treated HCC patients who had received both ICI and mTKI therapy,supporting further late-stage development of irpagratinib in such populations with substantial unmet medical need.

In addition,the design of the phase II study of pimicotinib in combination with chemotherapy and with/without toripalimab as first-line treatment for advanced pancreatic ductal adenocarcinoma (PDAC) has been presented.

About Irpagratinib (ABSK011)

Irpagratinib is a highly selective FGFR4 small molecule inhibitor intended for the treatment of advanced solid tumors that present with abnormalities in the FGF19/FGFR4 signaling pathway (e.g.,ligand FGF19 amplification/overexpression,FGFR4 mutation/amplification/fusion),including advanced HCC,cholangiocarcinoma,breast cancer,among others. The FGFR4 signaling pathway is a recognized and promising target for treating HCC. Clinical data with irpagratinib have demonstrated improved potency and anti-tumor efficacy,among other favorable therapeutic properties,compared to competitors.

AboutAbbiskoTherapeutics

Founded in April 2016,Abbisko Therapeutics Co.,Ltd.,a subsidiary of Abbisko Cayman Limited (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 Therapeutics has built an extensive pipeline of 16 innovative small molecule programs focused on precision oncology and immuno-oncology. Please visit www.abbisko.comfor more information.