Beijing InnoCare Pharma Tech Co. (HKG: 9969), a China-based biotech specializing in cancer and autoimmune diseases, has announced the latest data for its pan-fibroblast growth factor receptor (FGFR) inhibitor gunagratinib (ICP-192) in cholangiocarcinoma at the ASCO-GI 2023 meeting. The findings highlight the drug’s potential in treating this challenging form of cancer.
Phase IIa Study Results
The Phase IIa dosage expansion study is designed to assess the safety and efficacy of gunagratinib in patients with previously treated locally advanced or metastatic cholangiocarcinoma with abnormal FGFR gene expression. As of September 5, 2022, a total of 18 patients were enrolled, with an average age of 52 years and 44.4% being male. These patients received 20 mg of gunagratinib orally once daily. Among the 17 patients who completed at least one tumor evaluation, the overall response rate (ORR) was 52.9%, the disease control rate (DCR) was 94.1%, and the median progression-free survival (mPFS) was 6.93 months. Gunagratinib demonstrated good safety and tolerability.
Gunagratinib: Mechanism and Development
ICP-192 (gunagratinib) is a Category 1 small-molecule targeted therapy designed to selectively bind and inhibit FGFR, thereby blocking FGFR-related signaling pathways and controlling cancer cell proliferation. The drug is currently undergoing multiple clinical studies in both China and the US. In June 2021, gunagratinib received orphan drug designation (ODD) from the US FDA for the treatment of cholangiocarcinoma, positioning it as a potential new standard of care for patients with this disease.-Fineline Info & Tech
