Innovent Releases Phase 2 Results of Pemigatinib in Chinese Patients with Advanced Cholangiocarcinoma at ESMO Congress 2021

SAN FRANCISCO and SUZHOU,China,Sept. 17,2021 -- Innovent Biologics,Inc. ("Innovent",HKEX: 01801),a world-class biopharmaceutical company that develops,manufactures and commercializes high-quality medicines for the treatment of cancer,metabolic,autoimmune and other major diseases,announced that the results of the Phase 2 study in Chinese patients with advanced cholangiocarcinoma were released today at the European Society for Medical Oncology (ESMO) Congress 2021(E-poster # 50P).

This study,which is a bridging study of the FIGHT-202,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(CCA) with FGFR2 fusion/rearrangement that failed to prior systemic therapy. As of Jan 29,2021,the data cutoff date,3 subjects were enrolled and treated at 9mg pemigatinib in stage 1 to evaluate pharmacokinetic (PK) in Chinese population. The other 31 subjects with documented FGFR2 fusion or arrangement were enrolled in stage 2 and received 13.5mg pemigatinib. Subjects in both stages were orally given pemigatinib QD on a 2 weeks on/1 week off schedule until disease progression,unacceptable toxicity,withdrawal of consent,or physician decision. The primary endpoint was objective response rate (ORR) assessed by independent radiological review committee (IRRC) per RECIST V1.1 in 31 patients enrolled in stage 2. 30 subjects in stage 2 were included in the efficacy evaluable population with 1 participant excluded due to inadequate FGFR2 aberrant frequency. Among 30 efficacy evaluable subjects,15 of them had confirmed response assessed by IRRC,with an ORR of 50% (95%CI: 31.3%，68.7%). With a median follow up of 5.13 months,13 patients were still in response,the median DOR was not reached (95%CI: 3.4,NR). As of the data cut off date,progression free survival (PFS) data remained immature as it was only observed in 6 patients,the disease control rate (DCR) was 100% (95%CI: 88.4%,100%).

All 34 subjects in both stages were included for safety analysis. As of data cutoff date,each subject experienced at least 1 treatment-related adverse event(TRAE),the most common TRAE were hyperphosphatemia(73.5%),xerostomia(55.9%) and alopecia(50.0%),and 14.7% had grade 3 or higher TRAEs. Three participants had SAEs,which were rectal polyps,abnormal liver function and bile duct infection. There was no treatment discontinuation and deaths due to TRAE.

The principal investigator,Prof. Jian Zhou,from Fudan University Zhongshan Hospital,stated,"Intrahepatic Cholangiocarcinoma is the second most common type of cancer originated from liver. For advanced disease,the first line recommended therapy is gemcitabine plus cisplatin with an ORR of 26% and median overall survival (mOS) of 11.7 month,whose limited efficacy needs to be improved. For patients who failed the first line therapy,ASC+mFOLFOX will be administrated with an mOS of 5-6 months. There is an urgent need in drugs that can vastly change the landscape of treatment for intrahepatic cholangiocarcinoma. FGFR2 fusion/rearrangement is the most common FGFR alteration in intrahepatic cholangiocarcinoma,which is usually accompanied with more rapidly growth status. Pemigatinib is a selective FGFR1/2/3 inhibitor and has been proved with an positive efficacy and tolerable safety profile in studies conducted outside of China. This bridging study was aiming at evaluating the efficacy and safety in Chinese intrahepatic cholangiocarcinima patients. With this result of meeting a primary end point,I hope pemigatinib will provide a new and better therapy option for patients with intrahepatic cholangiocaricinoma once approved."

Dr. Hui Zhou,Senior Vice President of Innovent,stated "Innovent has multiple clinical trials of pemigatinib for the treatment of cholangiocarcinoma and other types of tumors. Currently our New Drug Application (NDA) of pemigatinib to National Medical Products Administration（NMPA）in China has been accepted and pemigatinb was approved in Taiwan market in June,earlier this year. The data presented at the ESMO Annual Meeting indicated that pemigatinib was highly effective and tolerable in Chinese patients with recurrent or metastatic CCA with FGFR2 fusion/rearrangement. In the future,we will conduct in-depth clinical development of pemigatnib to explore potential treatments in other indications. 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 tumor 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 patients have 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 or 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 Pemazyre,have shown 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 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.

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 26 valuable assets in major therapeutic areas,with 5 products officially approved for marketing in China - TYVYT® (sintilimab injection),BYVASDA® (bevacizumab biosimilar injection),SULINNO® (adalimumab biosimilar injection),HALPRYZA® (rituximab biosimilar injection),and PEMAZYRE® (pemigatinib oral inhibitor),1 asset's NDA under NMPA review,sintilimab's Biologics License Application (BLA) acceptance in the U.S.,5 assets in Phase 3 or pivotal clinical trials,and an additional 15 molecules in clinical studies.

Innovent has built an international team with advanced talent in high-end biological drug development and commercialization,including 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 help advance China's biopharmaceutical industry,improve drug availability and enhance the quality of the patients' lives. For more information,please visit: www.innoventbio.com. and www.linkedin.com/company/innovent-biologics/.

Note:

Sintilimab is not an approved product in the United States.

BYVASDA® (bevacizumab biosimilar injection),and SULINNO® (adalimumab biosimilar injection) are not approved products in the United States.

TYVYT® (sintilimab injection,Innovent)

BYVASDA® (bevacizumab biosimilar injection,Innovent)

HALPRYZA® (rituximab biosimilar injection,Innovent)

SULINNO® (adalimumab biosimilar injection,Innovent)

Pemazyre® (pemigatinib oral inhibitor,Incyte Corporation). Pemazyre® was discovered by Incyte Corporation and licensed to Innovent for development and commercialization in Mainland China,Macau and Taiwan.

Disclaimer:

1. This indication hasn't been approved in China.

2. Innovent does not recommend any off-label usage.

3. For medical and healthcare professionals only.

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