On April 19, 2023 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, autoimmune, metabolic, ophthalmology and other major diseases, reported that the overall survival (OS) results of the Phase 2 study of pemigatinib in Chinese patients with advanced cholangiocarcinoma (CCA) were presented today at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2023 (Abstract CT153) (Press release, Innovent Biologics, APR 19, 2023, View Source [SID1234630324]).
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This study (CIBI375A201, NCT04256980) is a Phase 2, open-label, multi-center, single-arm study to evaluate the efficacy and safety of pemigatinib – a selective fibroblast growth factor receptor (FGFR) inhibitor – in Chinese patients with unresectable, advanced/recurrent or metastatic cholangiocarcinoma with FGFR2 fusion/rearrangement that failed to prior systemic therapy, which is a bridging study of the FIGHT-202 study (INCB 54828-202, NCT08924376).
As of data cutoff date (Dec 28, 2022), 31 subjects with documented FGFR2 fusion or arrangement were enrolled and received pemigatinib 13.5mg QD on a 2 weeks on/1 week off schedule until disease progression, unacceptable toxicity, withdrawal of consent, or physician decision.
Among 30 efficacy evaluable subjects (1 participant excluded due to inadequate FGFR2 aberrant frequency), the median follow-up was 25.6 months (95% CI, 23.0-25.8), the median OS was 23.9 months (95% CI, 15.2-NC) with 16 (53.3%) OS events.
Estimated OS rates at 12 months, 18 months and 24 months were 73.3% (95% CI, 53.7%-85.7%), 66.5% (95% CI, 46.7%-80.4%), and 41.4% (95% CI, 22.4%-59.4%), respectively.
As previously reported, there were no clinically or statistically significant differences in safety outcomes with extended follow up of this study.
Dr. Hui Zhou, Senior Vice President of Innovent, stated: "This bridging study aimed to evaluate and validate the efficacy and safety of pemigatinib in Chinese patients with recurrent or metastatic cholangiocarcinoma with FGFR2 fusion or rearrangement, and previously efficacy and safety data was presented at the ESMO (Free ESMO Whitepaper) Congress 2021. These updated OS results demonstrate the encouraging and durable survival benefit of pemigatinib in Chinese patients. Pemigatinib provides an important treatment option for eligible Chinese cholangiocarcinoma patients. Innovent has an ongoing phase 3 study of pemigatinib as first line therapy for cholangiocarcinoma. We will conduct in-depth clinical development of pemigatinib to explore potential treatments in other indications as well. We are looking forward to providing novel therapies for more cancer patients in the future."
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 line treatment for patients with resectable disease. However, most cholangiocarcinomas have been in advanced and/or metastatic status at diagnosis and lost the chance for surgical resection. The treatment options for patients who relapse after surgery or have advanced / metastatic disease are limited and the recommended therapy method is systemic chemotherapy with gemcitabine 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 Pemazyre (pemigatinib)
Pemazyre (pemigatinib) is a selective, oral inhibitor of FGFR isoforms 1, 2 and 3. In December 2018, Innovent and Incyte entered into a strategic collaboration for three clinical-stage product candidates discovered by Incyte, including pemigatinib. 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 April 2020, the U.S. Food and Drug Administration (FDA) approved Pemazyre (pemigatinib) 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 August 2022, Pemazyre is also approved in the U.S. for the treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with FGFR1 rearrangement.
Pemazyre is approved and marketed by Innovent in Mainland China, Hongkong and Taiwan, for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a FGFR2 fusion or rearrangement as confirmed by a validated diagnostic test that have progressed after at least one prior line of systemic therapy.
Pemazyre is a trademark of Incyte Corporation. Pemazyre is marketed by Incyte in the United States, Europe and Japan.