Cinda Biotech's first small molecule anti-cancer drug, pemigatinib, has been declared for the market !
July 10, 2021
July 9, 2021, San Francisco, USA and Suzhou, China-Cinda Biopharmaceuticals (Hong Kong Stock Exchange stock code: 01801), a company dedicated to R&D, production and sales for the treatment of tumors, metabolic diseases, autoimmune diseases and other major diseases The innovative drug biopharmaceutical company announced today that the National Medical Products Administration (NMPA) has officially accepted fibroblast growth factor receptor (FGFR) 1/2/3 inhibitors (pemigatinib tablets) for use in at least one in the past Systemic treatment, and the new indications for the treatment of adult patients with advanced, metastatic or unresectable cholangiocarcinoma with FGFR2 fusion or rearrangement confirmed by testing have been applied for the marketing of new indications. Pemigatinib (a tyrosine kinase inhibitor) was jointly developed by Incyte and Innovent. Innovent is responsible for the commercialization of China, Hong Kong, Macau and Taiwan. On June 21, 2021, pemigatinib was approved in the Taiwan market (trade name: Dabotan®). It is the first small molecule drug product approved by Cinda Biotech, and it is also Cinda Biotech's fifth innovation approved for marketing. medicine. This new indication application submitted to NMPA is based on an evaluation in subjects with locally advanced, recurrent or metastatic cholangiocarcinoma that has failed at least first-line systemic treatment, accompanied by FGFR2 fusion or rearrangement, and is unresectable A phase II, open, single-arm, multi-center study of the efficacy and safety of pemigatinib. This study is also called CIBI375A201 (NCT04256980), which is the bridging test of the FIGHT-202 study (INCB 54828-202, NCT02924376) conducted abroad. The investigational drug pemigatinib in the two studies is a selective FGFR receptor tyrosine kinase inhibitor. The primary endpoints of the two studies were based on the objective response rate (ORR) evaluated by the Independent Imaging Committee (IRRC) according to the solid tumor evaluation standard V1.1. In the FIGHT-202 study, a total of 108 cholangiocarcinoma subjects were enrolled and received pemigatinib 13.5 mg oral treatment. The confirmed ORR based on IRRC assessment was 37% (95% CI: 27.94%, 46.86%), including 4 cases of complete remission (3.7%) and 36 cases of partial remission (33.3%), the median duration of remission (DOR) was 8.08 months (95% CI: 5.65, 13.14), and the median progression-free survival (PFS) was At 7.03 months (95% CI: 6.08, 10.48), pemigatinib can cause long-lasting tumor remission, with a median overall survival (OS) of 17.48 months (95% CI: 14.42, 22.93). A total of 147 subjects were included in the safety analysis, and the results showed that pemigatinib was well tolerated. Among them, hyperphosphatemia is the most common adverse reaction, with an incidence of 58.5%. 68.7% of subjects experienced grade 3 or higher adverse reactions. According to the preferred term, hypophosphatemia (14.3%) was the most commonly reported. Others included arthralgia and oral mucositis (6.1% each), Abdominal pain, fatigue, and hyponatremia (all 5.4%), other palm and plantar swelling syndrome and hypotension, occurred in 4.8% and 4.1%, respectively. The CIBI375A201 study, as the domestic bridging part of the FIGHT-202 study, has reached the main research endpoint of pre-communication with Chinese regulatory agencies. Therefore, based on the results of these two studies, a marketing application for new indications was submitted to the State Drug Administration. Dr. Zhou Hui, Senior Vice President of Clinical Development of Cinda Biopharmaceutical Group, said: “Bile duct cancer is the second most common malignant tumor originating in the liver. Infections with hepatitis B virus and other liver parasites have caused a higher incidence in Asia. Zhou Hui emphasized that most patients with cholangiocarcinoma are in a state of unresectable or metastatic tumors when they are first diagnosed, and treatment options are limited. The clinical trial data of pemigatinib in patients with advanced cholangiocarcinoma with FGFR2 fusion who have failed at least first-line standard treatment in the past have demonstrated the satisfactory safety and efficacy of pemigatinib. In view of the increasing treatment challenges of the refractory population and the promising data observed in the current study, we believe that patients with FGFR2 fusion or rearrangement may benefit from targeted therapy. We very much look forward to the approval of pemigatinib in China as soon as possible, bringing clinical benefits to more patients with cholangiocarcinoma.
About advanced cholangiocarcinoma and FGFR2 gene fusion/rearrangement
Cholangiocarcinoma is a malignant tumor that originates from bile duct epithelial cells. It can be divided into two categories: intrahepatic cholangiocarcinoma and extrahepatic cholangiocarcinoma. In recent years, the incidence of cholangiocarcinoma has been increasing year by year, and surgery is the only treatment with curative potential. However, most patients with cholangiocarcinoma are unresectable tumors or have metastases when they are first diagnosed, and have lost the opportunity for radical surgery. For patients with unresectable, metastatic or recurring cholangiocarcinoma after surgery, the first-line standard treatment is cisplatin combined with gemcitabine, which has poor efficacy and an overall survival time of less than 1 year. FGFR gene mutations exist in many types of human tumors, mainly through FGFR gene amplification, mutation, chromosomal translocation, and ligand-dependent activation of FGFR signal abnormalities. Fibroblast growth factor receptor signaling promotes the development of malignant tumors by promoting tumor cell proliferation, survival, migration and angiogenesis. Early clinical research results of selective FGFR inhibitors including pemigatinib showed that this class of drugs has tolerable safety and has preliminary signs of clinical benefit in subjects with FGF/FGFR variants.
About pemigatinib
Pemigatinib is a potent and selective oral inhibitor of FGFR subtype 1/2/3. In April 2020, the U.S. Food and Drug Administration (FDA) approved Incyte's Pemazyre® for the treatment of previously treated adults with advanced/metastatic or unresectable FGFR2 gene fusion/rearranged cholangiocarcinoma (passed FDA-approved test Method confirmation). The continued approval of this indication may depend on the verification and description of clinical benefits in confirmatory trials. In Japan, Pemazyre is approved to treat patients who have unresectable biliary tract cancer (BTC) with the FGFR2 fusion gene and have worsened after chemotherapy. In Europe, Pemazyre is approved for the treatment of FGFR2 fusion or rearrangement of locally advanced or metastatic cholangiocarcinoma and adult patients with disease progression after at least one previous systemic treatment. Pemazyre is sold by Incyte in the United States, Europe and Japan. In June 2021, Daburtan® (pemigatinib) was approved by the Food and Drug Administration (TFDA) of the Ministry of Health and Welfare of Taiwan to treat adults who have received systemic drug therapy and tumors with fibroblast growth factor receptor 2 (FGFR2) Locally advanced or metastatic cholangiocarcinoma that is fused or rearranged and cannot be resected. In December 2018, Innovent and Incyte reached a strategic cooperation on three drug candidates discovered and developed by Incyte, including pemigatinib, which are in clinical trials. According to the terms of the agreement, Cinda Bio has the rights to develop and commercialize pemigatinib in Mainland China, Hong Kong, Macau and Taiwan. In March 2020, Cinda Biosciences has completed the first patient administration in a pivotal trial for patients with advanced cholangiocarcinoma in China. Pemazyre is a trademark of Incyte Corporation.
