CStone Pharmaceuticals received approval to initiate clinical development in China of a combination therapy for patients with locally advanced to metastatic hepatocellular carcinoma, according to a press release.
The multicenter, open-label and multidose phase 1b/2 study will evaluate the safety, tolerability and efficacy of CS1001, an anti-PD-LI monoclonal antibody, with BLU-554, a potent and highly selective inhibitor of fibroblast growth factor receptor 4 (FGFR4).
“Emerging clinical data have shown encouraging results in HCC by combining immunotherapies with targeted therapies that are active as single agents,” Archie Tse, MD, PhD, chief translation medical officer of CStone, said in the release. “The combination of CS1001 and BLU-554 represents a great example of such an approach and a potential first-line treatment strategy for advanced HCC with FGF19-FGFR4 activation. We will rapidly advance the clinical development of this program to further explore these two promising drug candidates in combination.”
CS1001 is also being investigated for the treatment of lung and gastric cancers. Phase 1a data showed CS1001 was well-tolerated and demonstrated anti-tumor activity.
BLU-554 was well-tolerated and demonstrated encouraging anti-tumor activity in a phase 1 study and was granted orphan drug designation for HCC by the FDA.
“One of CStone’s missions is to develop novel therapies to address important unmet needs created by highly prevalent and difficult-to-treat cancers in China. Combination therapy and precision medicine are the core strategies of our pipeline,” Frank Jiang, MD, PhD, chairman and CEO of CStone, said in the release. “We expect the combination of BLU-554 with CS1001 can offer an important additional treatment option for this challenging disease.”