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Best Poster of ESMO 2024! Abbisko Announces Updated Clinical Data of Irpagratinib in HCC

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Best Poster of ESMO  2024! Abbisko Announces Updated Clinical Data of Irpagratinib in HCC
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Best Poster of ESMO 2024! Abbisko Announces Updated Clinical Data of Irpagratinib in HCC

2024-09-19 09:00 Last Updated At:09:15

SHANGHAI, Sept. 19, 2024 /PRNewswire/ -- 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.

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.  HCC is highly malignant, about 30% of which have abnormally high FGFR4 expression and a poor prognosis, and the existing treatment methods still cannot meet the long-term survival benefits.  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.

About Abbisko Therapeutics

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.com for more information.

** The press release content is from PR Newswire. Bastille Post is not involved in its creation. **

Best Poster of ESMO  2024! Abbisko Announces Updated Clinical Data of Irpagratinib in HCC

Best Poster of ESMO 2024! Abbisko Announces Updated Clinical Data of Irpagratinib in HCC

RIYADH, Saudi Arabia, Oct. 5, 2024 /PRNewswire/ --The Literature, Publishing & Translation Commission, part of the Saudi Ministry of Culture, has revealed that the Riyadh Book Fair 2024 is its largest edition yet, featuring a diverse range of translated international books. With more than 2,000 local, Arab, and international publishers participating, the Fair has strengthened its position as a leading cultural event in the Arab world. This year's edition promotes Saudi Arabia's cultural openness and supports the spread of cross-border knowledge.

The 2024 Fair edition stands out for hosting renowned thinkers, intellectuals, and global figures in literature, art, and knowledge who share their insights and success stories with the public. Among the key speakers are Fareed Zakaria, acclaimed media personality and author; Walter Isaacson, world-renowned biographer; poet and writer Kwame Alexander; and acclaimed novelist Jonathan Franzen. The Fair also features prominent literary and artistic figures from the Middle East.

Dr Mohammed Hasan Alwan, CEO of the Literature, Publishing & Translation Commission, emphasised the significance of the Fair, stating: "The Riyadh International Book Fair is not only one of the most important book fairs in the Arab region but also a premier platform for publishers and authors to expand their reach in the Arab cultural market. This year's edition is especially notable for its focus on cultural diversity and translation, with an exceptional programme featuring some of the world's leading intellectuals."

During his visit, His Excellency Chang Hua, the Chinese Ambassador to Saudi Arabia, expressed admiration for the Saudi public's enthusiasm for reading. CNN's Fareed Zakaria praised the Kingdom's remarkable transformation and its growing global influence.

This year also marks the return of the popular "Riyadh Reads French" initiative, featuring several French publishers. Al-Saeed Ezz, Communication Officer at the French Embassy, noted that this year's programme has expanded to include children's activities and free French language courses in collaboration with the French Cultural Institute, bringing French culture closer to Saudi visitors.

The Riyadh International Book Fair plays a key role in supporting Saudi Vision 2030's cultural goals, contributing to the Kingdom's cultural economy, projected to reach $9.3 billion. Attracting over one million visitors annually, it ranks among the highest-selling book fairs in the Arab world.

** The press release content is from PR Newswire. Bastille Post is not involved in its creation. **

Riyadh International Book Fair 2024: Expanding Global Dialogue through the Largest Collection of Translated Works

Riyadh International Book Fair 2024: Expanding Global Dialogue through the Largest Collection of Translated Works

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