Cinda Bio's FGFR inhibitor pemigatinib registered in China completed the first drug administration, has entered the review in the United States and Europe!

Innovent Biologics is a biopharmaceutical company dedicated to the development, production and sale of innovative drugs for the treatment of major diseases such as tumors, autoimmunity, and metabolic diseases. Recently, the company announced that its FGFR1 / 2/3 inhibitor pemigatinib (R 0010010 amp; D code: IBI375) phase 2 key registered clinical study has completed the first patient administration in China. The purpose of this study is to evaluate the effectiveness and safety of pemigatinib in Chinese patients with advanced cholangiocarcinoma who have received at least first-line system therapy, fibroblast growth factor receptor 2 (FGFR2) gene fusion, or rearrangement.

Professor Zhou Jian, deputy dean of Zhongshan Hospital affiliated to Fudan University, pointed out: 0010010 quot;The incidence of intrahepatic cholangiocarcinoma accounts for about 15-20% of primary liver malignancies, and it is on the rise. Most patients with intrahepatic cholangiocarcinoma are often accompanied by their first visit There is local invasion or distant metastasis and the opportunity for radical surgery is lost. Chemotherapy with gemcitabine combined with platinum is recommended as the first-line treatment for advanced cholangiocarcinoma, with an objective response rate (ORR) of 15-26%, and drug resistance often occurs. At present, there is a lack of other effective therapeutic drugs and programs in the clinic. Clinical research on FGFR-targeted pemigatinib in patients with early FGFR2 gene fusion or rearranged cholangiocarcinoma shows that the targeted drug has a significant effect on patients with advanced cholangiocarcinoma, And the safety is good. The ORR is 36%, the sustained remission time (DOR) is 7.5 months, and the overall survival (OS) is 21.1 months. The drug will bring new hope to patients with cholangiocarcinoma, and we are also looking forward to pemigatinib It has achieved good results in the clinical research for the treatment of patients with advanced cholangiocarcinoma in China. 0010010 quot;

Dr. Zhou Hui, Vice President of Medical Science and Strategic Oncology Department of Cinda Biopharmaceutical Group, said: 0010010 quot;Bile duct cancer is a malignant tumor that originates from cholangiocarcinoma cells. At present, the clinical treatment is limited, and the overall survival time of patients with advanced cholangiocarcinoma is relatively short. Great unmet medical needs. We are very pleased that the first patient has completed the first administration of pemigatinib. The results of this study will be used for the new drug application (NDA) of pemigatinib in China, which is an important milestone for pemigatinib 0010010 #39;s entry into the Chinese market. Based on the significant efficacy and safety data demonstrated by previous clinical research institutes, we believe that the launch of clinical trials of pemigatinib in China will benefit more patients with cholangiocarcinoma and bring more treatment options to clinicians. 0010010 quot;

Advanced cholangiocarcinoma and FGFR2 gene fusion / rearrangement: Cholangiocarcinoma is a malignant tumor that originates in bile duct epithelial cells, and can be divided into intrahepatic cholangiocarcinoma and extrahepatic cholangiocarcinoma according to the site of occurrence. In recent years, the incidence of cholangiocarcinoma has increased year by year. Surgery is the only treatment method with curative potential, but only a few early patients have surgery opportunities at the time of diagnosis. The recurrence rate of patients with radical resection is still high, and the current systemic treatment of inoperable or advanced cholangiocarcinoma is less effective. The standard treatment (cisplatin combined with gemcitabine) has an overall survival of less than 1 year.

Fibroblast growth factor receptor (FGFR) plays an important role in tumor cell proliferation, survival, migration and angiogenesis (new blood vessel formation). FGFR gene fusion / rearrangement, translocation and amplification are very likely to cause a variety of cancers. In cholangiocarcinoma, current research has confirmed that FGFR2 gene fusion / rearrangement can promote the occurrence and development of tumors, and targeting FGFR2 has a significant therapeutic effect on cholangiocarcinoma with such FGFR2 mutations.

pemigatinib (FGFR inhibitor, picture source: medchemexpress.cn)

Pemigatinib was discovered by Incyte, which is a potent and selective oral inhibitor for FGFR subtype 1/2/3. It has been confirmed in preclinical studies that the drug has selective pharmacology for tumor cells with FGFR mutation active.

In December 2018, Cinda Biotechnology and Incyte reached a strategic cooperation on the three clinical trial candidate drugs discovered and developed by Incyte, including pemigatinib (FGFR1 / 2/3 inhibitor), itacitinib (JAK1 inhibitor), parsaclisib (PI3Kδ inhibition Agent). According to the terms of the agreement, Cinda Biotech has obtained the right to develop and commercialize these three drug candidates in the field of hematological diseases and tumor treatment in mainland China, Hong Kong, Macau and Taiwan.

In November 2019, the US Food and Drug Administration (FDA) formally accepted the new drug application (NDA) of pemigatinib submitted by Incyte for the treatment of recurrent FGFR2 gene fusion or rearrangement of locally advanced cholangiocarcinoma, and granted it priority review qualifications. According to the US Prescription Drug User Fee Act (PDUFA), the approval date for pemigatinib in the United States is expected to be May 30, 2020. Previously, pemigatinib has received the FDA 0010010 #39;s 0010010 quot;breakthrough therapy designation 0010010 quot; for the treatment of previously treated advanced / metastatic or unresectable FGFR2 gene translocation cholangiocarcinoma. In addition, the FDA also granted pemigatinib orphan drug designation for the treatment of cholangiocarcinoma. This type of designation is generally granted to research compounds that are planned for the safe and effective treatment, diagnosis, or prevention of rare diseases affecting less than 200,000 people.

In January 2020, the European Medicines Agency (EMA) formally accepted the marketing authorization application (MAA) of pemigatinib submitted by Incyte for the treatment of relapsed or refractory disease, carrying fibroblasts after having previously received at least one systemic therapy Adult patients with locally advanced or metastatic cholangiocarcinoma, fused or rearranged with growth factor receptor 2 (FGFR2). EMA has confirmed that the materials in MAA are sufficiently complete and has initiated a formal review process.