January 16, 2020
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Combination therapy trial for locally advanced, metastatic HCC underway

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CStone Pharmaceuticals and Blueprint Medicines Corporation announced the first patient dosed in a phase 1b/2 trial of fisobatinib in combination with CS1001 for the treatment of locally advanced or metastatic hepatocellular carcinoma, according to a press release.

Investigators will assess the potential for two complementary treatment approaches including precision therapy and immune-oncology therapy to enhance anti-tumor activity at multiple clinical sites in China.

“HCC is a particularly aggressive disease and China is currently faced with enormous challenges due to limited effective treatment options and poor prognosis in HCC patients at advanced stages,” Archie Tse, MD, PhD, chief translational medicine officer at CStone, said in the release. “CStone is committed to addressing unmet clinical needs through identifying potentially transformative combination regimens against complex cancers like HCC.”

Fisogatinib is an investigational, potent and highly-selective inhibitor of fibroblast growth factor receptor 4 discovered by Blueprint Medicines. Data from an ongoing phase 1 trial showed that fisogatinib monotherapy was clinically active and well-tolerated in patients with heavily pretreated advanced HCC.

CS1001 is an investigational anti-PD-L1 monoclonal antibody under development by CStone for multiple tumor types. Data from a phase 1 dose-escalation study of CS1001 demonstrated sustained clinical benefits in gastric cancer and esophageal cancer. Additionally, pooled safety data from the phase 1b trial showed that CS1001 had a promising safety and tolerability profile.

“We look forward to advancing our fisogatinib clinical program by conducting a phase 1b/2 trial in China, where the incidence of HCC is disproportionately high,” Andy Boral, MD, PhD, chief medical officer at Blueprint Medicines, said. “Because fisogatinib has exquisite selectivity against an oncogenic driver, we believe this investigational treatment is well-positioned for combination therapy.”

Reference: www.cstonepharma.com