HLB releases 토토 바카라 clinical trial abstract in cholangiocarcinoma, confirming best-in-class

[by Kang, In Hyo] HLB's cholangiocarcinoma treatment candidate, ‘lirafugratinib,’ which is scheduled for submission to the U.S. Food and Drug Administration (FDA) in January, demonstrated an objective response rate (ORR) of 47% in a global Phase 2 clinical trial. These results indicate clinically competitive efficacy compared to currently approved pan-FGFR inhibitors. The company expects that the positive and clinically relevant final clinical data will continue to serve as a positive driver throughout the FDA review and approval process.

HLB announced on January 6 that an abstract reporting Phase 2 clinical trial results for 토토 바카라, conducted by its U.S. subsidiary, Elevar Therapeutics, was presented at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI 2026). The study assessed the efficacy and safety profile of 토토 바카라 in previously treated patients with FGFR2 fusion/rearrangement cholangiocarcinoma. The paper has been selected for oral presentation at ASCO GI 2026, scheduled to take place in San Francisco, United States, from January 8 to 10 (local time).

According to the abstract, the primary endpoint, ORR, as evaluated by an Independent Review Committee (IRC) in accordance with Response Evaluation Criteria in Solid Tumors (RECIST v1.1), reached 47%. In addition, the secondary endpoint, median duration of response (mDOR), was reported as 11.8 months (95% CI, 7.5–13.0).

The company highlighted the significance of this presentation, noting that it constitutes the first comprehensive dataset focused on patients with cholangiocarcinoma harboring FGFR2 fusions or rearrangements. HLB further emphasized that the findings demonstrated favorable clinical outcomes across key efficacy endpoints assessed by the IRC when compared with competing therapies. For context, the ORR of ‘pemigatinib’ and ‘futibatinib’, pan-FGFR inhibitors already approved for the indication of cholangiocarcinoma, were 36% and 42%, respectively, while the corresponding mDOR were 9.1 months and 9.7 months.

In terms of safety, the Phase 2 clinical data indicated that the most frequent Grade 3 or higher treatment-related adverse events (TRAEs) were palmar-plantar erythrodysesthesia syndrome (PPS) in 32.8% of patients and stomatitis in 12.1%. These adverse events were described as predictable, consistent with the pharmacological mechanism of FGFR2 inhibitors, and generally manageable through dose modification. Notably, the rate of permanent treatment discontinuation due to adverse events associated with 토토 바카라 was low at 4.3%, which compares favorably with rates reported for existing treatments, including pemigatinib (9.0%) and futibatinib (4.9%). In addition, the company reported that no treatment-related deaths were observed, highlighting a favorable tolerability profile for the candidate.

“These findings indicate that lirafugratinib delivers both ‘clinically meaningful antitumor activity’ and a ‘manageable safety profile’ in patients with cholangiocarcinoma harboring FGFR2 fusions or rearrangements, supporting its potential to provide differentiated therapeutic value as a highly selective FGFR2 inhibitor compared with existing treatment options. We anticipate that these clinical data will constitute important evidence during the FDA review and approval process,” said Nam Kyung-sook, Managing Director of the Bio Strategy Team at HLB Group.