Shanghai-based biotechnology company Abbisko Therapeutics Co., Ltd (HKG: 2256) has received approval from the National Medical Products Administration (NMPA) to conduct a Phase II clinical study for its pipeline candidate irpagratinib (ABSK121) in combination with lenvatinib for the treatment of advanced or irresectable hepatocellular carcinoma (HCC). This development marks a significant step in the exploration of novel therapeutic options for HCC patients.
Irpagratinib: A Promising FGFR Inhibitor for Solid Tumors
Irpagratinib is a fibroblast growth factor receptor (FGFR) drug resistance and mutation inhibitor under development to treat solid tumors, particularly those with FGF19 overexpression. In December 2022, a Phase I study for irpagratinib as a second-line treatment for Chinese HCC patients with FGF19 overexpression yielded preliminary results, demonstrating excellent safety and efficacy. Furthermore, irpagratinib in combination with the PD-L1 inhibitor atezolizumab is also being assessed in a Phase II study for advanced HCC patients, highlighting the drug’s potential in combination therapies.
Lenvatinib: A Multi-Indication Tyrosine Kinase Inhibitor
Lenvatinib, marketed as Lenvima by Eisai, is a tyrosine kinase receptor inhibitor approved by the US FDA for the treatment of differentiated thyroid carcinoma (DTC), renal cell carcinoma (RCC), HCC, and endometrial carcinoma (EC). The drug was approved in China for the treatment of HCC and DTC in 2018 and 2020, respectively, indicating its broad application in oncology.
Phase I Trial Approval in the United States
In addition to the clinical advancements in China, a Phase I trial for irpagratinib in the United States has recently gained approval, further expanding the global reach of Abbisko’s pipeline candidate and its potential impact on cancer treatment.-Fineline Info & Tech
