Innovent announces the approval of Pemazyre® (pemigatinib) in the Taiwanese market for the treatment of adults with locally advanced unresectable or metastatic cholangiocarcinoma previously treated with FGFR2 fusion or rearrangement
SAN FRANCISCO and SUZHOU, China, June 21, 2021 / PRNewswire / – Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and markets high-quality drugs for the treatment of cancer, metabolic, autoimmune and other major diseases reported that The Taiwan market has approved Pemazyre® (pemigatinib) for the treatment of adults with previously treated locally advanced or metastatic, unresectable cholangiocarcinoma with fusion or rearrangement of the fibroblast growth factor 2 (FGFR2) receptor. Pemazyre, discovered by Incyte and licensed to Innovent for development and commercialization in mainland China, Hong Kong, Macau and Taiwan, is the first tyrosine kinase inhibitor approved for the treatment of cholangiocarcinoma, a type of cancer of the bile ducts, in Taiwan market. It is the first small molecule drug approved by Innovent and also its fifth approved innovative drug.
The approval was based on the FIGHT-202 study, which is a phase 2, multicenter, open-label, single-arm study (NCT02924376) evaluating the safety and efficacy of Pemazyre – a selective inhibitor of the factor receptor growth rate of fibroblasts (FGFR) – in adult patients (age ≥18 years) with locally advanced or metastatic cholangiocarcinoma previously treated with fusion or documented rearrangement of FGFR2. The main measure of effectiveness was the overall response rate (ORR) determined by an independent review committee according to RECIST V1.1. Among the 107 patients with FGFR 2 fusion / rearrangement, the ORR was 35.5% (95% CI: 27%, 45%), including 3 complete responses. The median duration of response (DOR) was 9.1 months with responses lasting ≥ 6 months in 24 of 38 (63%) responder patients and ≥ 12 months in 7 (18%) patients. The safety analysis, including 146 patients, demonstrated that pemigatinib was generally well tolerated. Hyperphosphatemia was the most common treatment-related adverse event (TSE) (60%). Grade 3 or greater ATEs were reported in 64% of patients; the most frequent of which were hypophosphatemia (12%), arthralgia (6%), stomatitis (5%), hyponatremia (5%), abdominal pain (5%) and fatigue (5%) . For more information on FIGHT-202, please visit https://clinicaltrials.gov/ct2/show/NCT02924376 or https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(20)30109- 1 / fulltext.
Dr. Yongjun Liu, President of Innovent, said: “The approval of Pemazyre in Taiwan represents that Innovent has further expanded its product portfolio. Going forward, Innovent will leverage innovative drug synergies to explore more opportunities for combination therapies to address unmet medical needs. ‘
Dr. Hui Zhou, Senior Vice President of Clinical Development at Innovent, said: “Cholangiocarcinoma is the second most common primary liver cancer with a high incidence in Asia due to the relatively widespread infection with HBV and parasites. ‘ He pointed out that a significant portion of patients receive an initial diagnosis of unresectable and / or metastatic condition with limited therapeutic choice. Data from previous clinical trials of Pemazyre in participants with advanced cholangiocarcinoma with FGFR2 fusion as second-line or subsequent treatment not only showed satisfactory safety results, but also revealed convincing efficacy signals. With refractory subjects considered the most difficult population and based on promising data, we believe that patients with FGFR2 fusion or rearrangement may benefit from targeted therapies. The approval is an important clinical milestone, and we look forward to seeing the therapeutic contribution of Pemazyre in the treatment of eligible patients with cholangiocarcinoma in Taiwan market, ”said Dr. Zhou.
About advanced cholangiocarcinoma and FGFR2 rearrangement
Cholangiocarcinoma is a malignant tumor arising from the cells of the biliary epithelium and it is classified as intrahepatic or extrahepatic depending on the anatomical location of origin. The incidence of cholangiocarcinoma has increased steadily over the past decade. Surgery is the first priority for patients with resectable disease. However, most cholangiocarcinomas were advanced and / or metastatic at the time of diagnosis and have lost the possibility of surgical resection. Treatment options for patients who relapse after surgery or who have advanced / metastatic disease are limited and the recommended treatment method is systemic chemotherapy with gemicitabine plus cisplatin, which has an average overall survival of less than one year.
Aberrant FGFR signaling resulting from gene amplification or mutation, chromosomal translocation and ligand-dependent activation of receptors has been demonstrated in several types of human cancer. Fibroblast growth factor receptor signaling contributes to the development of malignant tumors by promoting proliferation, survival, migration and angiogenesis of tumor cells. Results of early clinical studies with selective FGFR inhibitors, including Pemazyre, showed a tolerable safety profile for the class and preliminary signs of clinical benefit in participants with FGF / FGFR alterations.
About Pemazyre® (pemigatinib)
In april 2020, the United States Food and Drug Administration (FDA) has approved Pemazyre® (pemigatinib) from Incyte, a selective oral inhibitor of FGFR isoforms 1, 2 and 3, for the treatment of adults with local cholangiocarcinoma advanced unresectable or metastatic with previously treated fibroblast fusion or rearrangement of growth factor 2 receptor (FGFR2) as detected by an FDA approved test. Continued approval for this indication may depend on verification and description of clinical benefit in one or more confirmatory trials.
In Japan, Pemazyre is approved for the treatment of patients with bile duct cancer unresectable with an FGFR2 fusion gene, worsening after cancer chemotherapy. In Europe, Pemazyre is approved for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with fusion or rearrangement of FGFR2 who have progressed after at least one previous line of systemic treatment. Pemazyre is marketed by Incyte in United States, Europe and Japan.
In december 2018, Innovent and Incyte have 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 received the development and commercialization rights for the three assets in mainland China, Hong Kong, Macau and Taiwan. In March 2020, Innovent announced that the first patient received a dose in the pivotal registration trial evaluating pemigatinib in patients with advanced cholangiocarcinoma in Mainland china. In June 2021, Taiwan approved market Pemazyre® (pemigatinib) for the treatment of adults with locally advanced unresectable or metastatic cholangiocarcinoma previously treated with fusion or rearrangement of FGFR2.
Pemazyre is a trademark of Incyte Corporation.
Inspired by the spirit of “Start with Integrity, Succeed with Action”, Innovent’s mission is to develop, manufacture and market high quality biopharmaceuticals that are affordable to ordinary people. Founded in 2011, Innovent is committed to developing, manufacturing and commercializing high quality innovative drugs for the treatment of cancer, autoimmune, metabolic and other major diseases. At October 31, 2018, Innovent has been listed on the Main Board of the Hong Kong Stock Exchange Limited with the stock code: 01801.HK.
Since its inception, Innovent has developed a fully integrated, multi-functional platform that includes R&D, CMC (chemistry, manufacturing and controls), clinical development and commercialization capabilities. By leveraging the platform, the company has built a strong pipeline of 24 valuable assets in cancer, metabolic disease, autoimmune and other major therapeutic areas, with 5 products – TYVYT® (injection of sintilimab), BYVASDA® (biosimilar injection of bevacizumab), SULINNO® (biosimilar injection of adalimumab), HALPRYZA® (biosimilar injection of rituximab) and PEMAZYRE® (oral pemigatinib inhibitor) – officially approved for marketing, acceptance of sintilimab biological license application (BLA) in the United States, 5 active ingredients in phase 3 or pivotal clinical trials, and 14 additional molecules in clinical trials. In 2019, TYVYT® was the first PD-1 inhibitor included in the National Reimbursed Medicines List (NRDL) and the only PD-1 inhibitor included in the NRDL that year.
Innovent has built an international team with advanced talents in the development and commercialization of high-end biologics, comprising many global 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 many collaborators to advance from China the biopharmaceutical industry, improve the availability of drugs and improve the quality of life of patients. For more information, please visit: www.innoventbio.com.
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