Innovent Announces First Patient Dosed in China in the Global Phase 3 Clinical Trial of Pemigatinib as the First-line Treatment of Unresectable or Metastatic Cholangiocarcinoma
Innovent Biologics has successfully initiated a global Phase 3 clinical trial for pemigatinib (IBI375), designed to treat unresectable or metastatic cholangiocarcinoma in China. The trial evaluates pemigatinib against the standard treatment of gemcitabine plus cisplatin, targeting patients with FGFR2 rearrangement. Dr. Hui Zhou noted the urgent need for improved therapies given the poor prognosis associated with existing treatments. Previous studies showed pemigatinib provided satisfactory safety with promising efficacy signals, suggesting a potential benefit for targeted therapy in this challenging patient population.
- First patient successfully enrolled and dosed in a pivotal Phase 3 trial for pemigatinib.
- Pemigatinib has shown an objective response rate of 35.5% and an estimated overall survival of 21.1 months in previous studies.
- Potential to improve treatment outcomes for patients with unresectable or metastatic cholangiocarcinoma.
- Current standard treatment has a low response rate of 26%, with limited treatment options for advanced cholangiocarcinoma.
SAN FRANCISCO and SUZHOU, China, May 24, 2021 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, metabolic, autoimmune and other major diseases, today announces that the first patient has been successfully enrolled and dosed in the clinical trial of pemigatinib (IBI375), a fibroblast growth factor receptor 1/2/3 (FGFR1/2/3) inhibitor, for the treatment of unresectable or metastatic cholangiocarcinoma in China. The study is a key component of the global Phase 3 clinical trial, which evaluates the efficacy and safety of pemigatinib versus gemcitabine plus cisplatin in first-line treatment of participants with unresectable or metastatic cholangiocarcinma with a fibroblast growth factor receptor 2 (FGFR2) rearrangement.
Dr. Hui Zhou, the Senior Vice President of Innovent, stated: 'Cholangiocarcinoma is the second most common primary liver cancer with a high incidence in Asia due to relatively widespread infection of HBV and parasites.' He emphasized that a significant portion of patients receive an initial diagnosis of unresectable and/or metastatic status and that first-line systemic therapy is typically gemcitabine plus cisplatin, with a response rate of
About Advanced Cholangiocarcinoma and FGFR2 Rearrangement
Cholangiocarcinoma is a malignant tumour originated from biliary epithelium cells and it is categorized as intrahepatic or extrahepatic based on anatomical location of origin. The incidence of cholangiocarcinoma has been increasing progressively over the past decade. Surgery is the first priority for patients with resectable disease. However, most cholangiocarcinomas has been in advanced and/or metastatic status at diagnosis and lost the chance for surgical resection. The treatment options for patient who relapse after surgery or have advanced / metastatic disease are limited and the recommended therapy method is systemic chemotherapy with gemicitabine plus cisplatin, which has a medium overall survival of less than a year.
Aberrant signaling through FGFR resulting from gene amplification or mutation, chromosomal translocation, and ligand-dependent activation of the receptors has been demonstrated in multiple types of human cancers. Fibroblast growth factor receptor signaling contributes to the development of malignancies by promoting tumor cell proliferation, survival, migration, and angiogenesis. Results from early clinical studies of selective FGFR inhibitors, including pemigatinib, have shown a tolerable safety profile for the class and preliminary signs of clinical benefit in participants with FGF/FGFR alterations.
About Pemigatinib (Pemazyre®)
In April 2020, the U.S. Food and Drug Administration (FDA) approved Incyte's Pemazyre® (pemigatinib), a selective, oral inhibitor of FGFR isoforms 1, 2 and 3, for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement as detected by an FDA-approved test. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
In Japan, Pemazyre is approved for the treatment of patients with unresectable biliary tract cancer with a FGFR2 fusion gene, worsening after cancer chemotherapy. In Europe, Pemazyre is approved for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a FGFR2 fusion or rearrangement that have progressed after at least one prior line of systemic therapy. Pemazyre is marketed by Incyte in the United States, Europe and Japan.
In December 2018, Innovent and Incyte entered into a strategic collaboration for three clinical-stage product candidates discovered and developed by Incyte, including pemigatinib (FGFR1/2/3 inhibitor). Under the terms of the agreement, Innovent has received the rights to develop and commercialize the three assets in Mainland China, Hong Kong, Macau and Taiwan. In March 2020, Innovent announced that the first patient was dosed in the pivotal registrational trial evaluating pemigatinib in patients with advanced cholangiocarcinoma in China.
Pemazyre is a trademark of Incyte Corporation.
About Innovent
Inspired by the spirit of "Start with Integrity, Succeed through Action," Innovent's mission is to develop, manufacture and commercialize high-quality biopharmaceutical products that are affordable to ordinary people. Established in 2011, Innovent is committed to developing, manufacturing and commercializing high quality innovative medicines for the treatment of cancer, autoimmune, metabolic diseases, and other major therapeutic areas. On October 31, 2018, Innovent was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 01801.HK.
Since its inception, Innovent has developed a fully integrated multi-functional platform which includes R&D, CMC (Chemistry, Manufacturing, and Controls), clinical development and commercialization capabilities. By leveraging this platform, the company has built a robust pipeline of 23 valuable assets in major therapeutic areas, with 4 products officially approved for marketing in China - TYVYT® (sintilimab injection), BYVASDA® (bevacizumab biosimilar injection), SULINNO® (adalimumab biosimilar injection) and HALPRYZA® (rituximab biosimilar injection), one Biologics License Application (BLA) submission for sintilimab accepted by the U.S. FDA, five assets in Phase 3 or pivotal clinical trials, and 14 more molecules in clinical trials. TYVYT® (sintilimab injection) was included in the National Reimbursement Drug List (NRDL) in 2019 as the historically first PD-1 inhibitor entering in NRDL and the only PD-1 included in the list in that year.
Innovent has built an international team of advanced talented professionals in high-end biopharmaceutical development and commercialization, including many overseas experts. The company has also entered into strategic collaborations with Eli Lilly and Company, Adimab, Incyte, MD Anderson Cancer Center, Hanmi and other international partners. Innovent strives to work with all relevant parties to help advance China's biopharmaceutical industry, improve drug availability to ordinary people and enhance the quality of the patients' lives. For more information, please visit: www.innoventbio.com.
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