Innovent's small-molecule antitumor drug pemigatinib for cholangiocarcinoma is expected to be approved in the near future

It was learned on March 22 that the marketing application of Innovent Bio-Fibroblast Growth Factor Receptor (FGFR) 1/2/3 inhibitor pemigatinib tablets has left the first round of supplementary data queue, and is one step closer to being approved for marketing

Pemigatinib was developed by Incyte and was approved for marketing in the United States in April 2020 under the trade name Pemazyre®

Innovent Bio reached a strategic cooperation with Incyte in December 2018, and obtained the clinical development and commercialization rights of the company's 3 drugs, including pemigatinib, in mainland China, Hong Kong, Macao and Taiwan, while Incyte acquired the rights of Incyte Bio.

On June 21, 2021, pemigatinib was approved in the Taiwan market (Chinese generic name: pimetinib; trade name: Dabtan®), becoming the first small molecule drug product approved by Innovent; January 2022 On March 24, pemigatinib was approved again in Hong Kong

According to the Insight database, pimetinib was filed for listing in mainland China in July 2021, and was subsequently included in the priority review list by CDE for at least one systemic therapy previously received and the presence of FGFR2 fusions confirmed by testing or rearranged advanced, metastatic, or unresectable cholangiocarcinoma in adults

Overview of the domestic research and development progress of the "pemetinib" project

From: Insight database project progress module (http://db.

The marketing application of pimetinib in China is based on a trial in subjects with FGFR2 fusion or rearrangement, unresectable locally advanced, recurrent or metastatic cholangiocarcinoma who have failed at least one line of systemic therapy Phase II, open-label, single-arm, multicenter study to evaluate the efficacy and safety of pemigatinib

In the FIGHT-202 study, a total of 108 subjects with cholangiocarcinoma were enrolled and received pemigatinib 13.

DOI: 10.

JournalofClinicalOncology39, no.

In terms of safety, pemigatinib was well tolerated

The data of the domestic bridging trial INCB54828-202 has also been released in the form of a poster at ESMO 2021

Among the 30 efficacy-evaluable populations, 15 patients achieved IRRC-confirmed disease remission, and the primary endpoint ORR reached 50% (95% CI: 31.

Biliary tract cancer (BTC) is a rare, aggressive cancer that develops in the bile ducts and gallbladder

Cholangiocarcinoma Indication Hierarchy (Insight)

From: Insight database indication module (http://db.

Surgery is currently the only treatment with curative potential, but most patients with cholangiocarcinoma have unresectable tumors or metastases at the time of initial diagnosis, losing the opportunity for radical surgery

From the perspective of targeted drugs, the FDA has only approved 3 targeted drugs for cholangiocarcinoma
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These three cholangiocarcinoma treatment drugs have just been approved in 2020 and 2021, two of which are FGFR inhibitors, Innovent/Incyte's Pemigatinib and Liantuo/BrigeBio's Infigratinib; one is the IDH1 inhibitor Ivory Cloth, developed by Agios Pharmaceuticals and introduced by CStone
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From the perspective of immunotherapy, this type of cancer is also experiencing setbacks.
In 2021, Merck's PD-L1/TGFβ bispecific fusion protein M7824 suffered a first- and second-line second-line losing streak in biliary tract cancer
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The first positive breakthrough was AstraZeneca's PD-L1 durvalumab (Imfinzi), which is expected to break zero in the field of immunotherapy in biliary tract cancer only after this new indication is declared this year
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