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Cornerstone Pharmaceutical Partner Agios Announces TIBSOVO (ivosidenib) Phase III ClarIDHy Clinical Trial Realizes Its Primary Endpoint

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Friday, May 24, 2019

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Suzhou, China, May 23, 2019 - Cornerstone Pharmaceuticals (Suzhou) Co., Ltd. (hereinafter referred to as "Foundation Pharmaceuticals" or "Company", Hong Kong Stock Exchange Code: 2616) Partner Agios Pharmaceuticals, Inc. (hereinafter referred to as " Agios" announced that the TIBSOVO (ivosidenib) Global Phase III ClarIDHy trial reached its primary endpoint. This trial is directed to previously treated patients with cholangiocarcinoma who carry the isocitrate dehydrogenase 1 (IDH1) mutation. After independent radiology review, the progression-free survival (PFS) of TIBSOVO was found to have a statistically significant improvement compared with patients receiving placebo. The safety data observed in the study is consistent with previous published data.

A comprehensive analysis of the ClarIDHy trial will be presented at the 2019 European Congress of Oncology. Agios plans to submit a new drug application for TIBSOVO for the previously treated IDH1 mutation with cholangiocarcinoma by the end of 2019. 

Cholangiocarcinoma is an aggressive tumor, and surgical resection is the primary method for the treatment of cholangiocarcinoma. Many patients have been diagnosed at an advanced stage of the disease and therefore missed the opportunity for surgery. Currently, there are no standard second- and third-line treatment options for advanced cholangiocarcinoma. Patients usually have a poor prognosis and short survival.

Cholangiocarcinoma may be associated with a variety of high-risk factors, including viral hepatitis and Clonorchis sinensis infection. China is a prevalent area for hepatitis B and clonorchiasis infection, and is one of the countries with the highest incidence of cholangiocarcinoma in the world. 

In June 2018, Cornerstone Pharmaceuticals and Agios reached an exclusive agreement to develop and commercialize TIBSOVO in Greater China.

ClarIDHy Phase III Trial
ClarIDH is a global randomized phase III clinical trial of patients with advanced cholangiocarcinoma who carry IDH1 mutations who have recorded disease progression after one or two systemic treatments. As of January 31, 2019, a total of 185 patients were randomized.
  • Patients were randomized to receive a single dose of TIBSOVO 500 mg once daily or placebo in a 2:1 ratio. Patients in the placebo group were allowed to take turns to the TIBSOVO group for treatment of radiological progression according to RECIST 1.1 criteria.
  • The primary endpoint of the trial was PFS assessed by independent radiology review. Secondary endpoints included PFS assessed by the investigator, safety and tolerability, overall response rate, overall survival, duration of remission, PK/PD, and quality of life. Evaluation.
  • The study design had a 96% confidence that the risk ratio for detectable PFS was 0.5 (TIBSOVO versus placebo), with a one-sided alpha of 0.025.
  • Thermo Fisher Scientific (NYSE: TMO) is providing next-generation sequencing to detect IDH1 mutations in all tumor samples as an inclusion criteria for study enrollment and will develop and commercialize validated companion diagnostics.
TIBSOVO has not been approved for the treatment of patients with advanced cholangiocarcinoma in any country.

About TIBSOVO (ivosidenib)
TIBSOVO (ivosidenib) is an isocitrate dehydrogenase-1 (IDH1) inhibitor that is used in the United States to treat susceptible IDH1 mutations after FDA-approved testing.
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About Cornerstone Pharmaceuticals
Cornerstone Pharmaceuticals (HKEX: 2616) is a biopharmaceutical company focused on the development and commercialization of innovative oncology immunotherapy and precision therapeutics to meet the ardent medical needs of cancer patients in China and around the world. Established at the end of 2015, Keshi Pharmaceutical has assembled a world-class management team with extensive experience in new drug development, clinical research and commercialization. With the core of combination therapy, the company has established a powerful tumor drug pipeline consisting of 15 tumor candidate drugs. Currently, five late drug candidates are at or near critical trials. With an experienced team, extensive pipelines, strong clinical development-driven business models and ample funding, Cornerstone's vision is to become the world's leading leading biopharmaceutical company by bringing innovative cancer therapies to cancer patients around the world.

For more information, please visit



Source: cstonepharma
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