福巴替尼对特定基因突变的胆管癌患者效果如何？

Forbatinib has a better effect on patients with cholangiocarcinoma with specific gene mutations, especially in the treatment of cholangiocarcinoma carrying fibroblast growth factor receptor 2 (FGFR2) gene fusion or other rearrangements. It can significantly reduce symptoms such as jaundice, abdominal pain, fever, nausea, abdominal masses, etc. It can greatly extend the survival time of patients and improve the 5-year survival rate.

Indications for Forbatinib

It is an orally bioavailable, selective and irreversible FGFR inhibitor used to treat cancers including cholangiocarcinoma, breast cancer, gastric cancer, urothelial cancer, esophageal cancer and non-small cell lung cancer.

Forbatinib, developed by Taihe Oncology and Taihe Pharmaceuticals, was approved in the United States on September 30, 2022 for the treatment of adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma carrying fusion or other rearrangements of the fibroblast growth factor receptor 2 (FGFR2) gene. It can reduce tumor cell proliferation and accelerate tumor cell death with FGFR gene mutations.

In a multicenter, open-label, single-arm trial, 103 patients with previously treated, unresectable, locally advanced, or metastatic intrahepatic cholangiocarcinoma with FGFR2 gene fusions or other rearrangements were enrolled. Use next-generation sequencing testing to determine the presence of FGFR2 fusions or other rearrangements. Patients received 20 mg of forbatinib orally once daily until disease progression or unacceptable toxicity.

The primary efficacy outcome measures were overall response rate (ORR) and duration of response (DoR) as determined by an independent review committee according to RECIST v1.1. The ORR was 42%, with all 43 responders achieving a partial response. The median DoR is 9.7 months.

Clinical study effect of fobatinib on cholangiocarcinoma with specific gene mutations

Research background

Forbatinib is a covalently bound FGFR1-4 inhibitor that has been shown to have anti-tumor activity in patients with FGFR-altered tumors and has strong preclinical activity against acquired resistance mutations associated with ATP-competitive FGFR inhibitors.

Research Methods

In this multinational, open-label, single-arm, phase 2 study, 103 patients with unresectable or metastatic FGFR2 fusion-positive or FGFR2 rearrangement-positive intrahepatic cholangiocarcinoma who had disease progression after one or more prior systemic therapies received oral fortibatinib 20 mg once daily continuously.

Research results

A total of 43 of 103 patients responded. The median duration of response was 9.7 months, the median follow-up time was 17.1 months, the median progression-free survival was 9 months, and the overall survival was 21.7 months.

Study conclusion

In patients previously treated with FGFR2 fusion or rearrangement-positive intrahepatic cholangiocarcinoma, the use of the covalent FGFR inhibitor fortibatinib can bring measurable clinical benefit.

Summary

Forbatinib has good efficacy in patients with cholangiocarcinoma with specific gene mutations. The specific efficacy and patient response may vary due to individual differences. Therefore, when using forbatinib, it is necessary to closely monitor the patient's treatment response and adjust the treatment plan as needed.

If you want to know more about forbatinib, you can read the article:

References:

Goyal L, Meric-Bernstam F, Hollebecque A, Valle JW, Morizane C, Karasic TB, Abrams TA, Furuse J, Kelley RK, Cassier PA, Klümpen HJ, Chang HM, Chen LT, Tabernero J, Oh DY, Mahipal A, Moehler M, Mitchell EP, Komatsu Y, Masuda K, Ahn D, Epstein RS, Halim AB, Fu Y, Salimi T, Wacheck V, He Y, Liu M, Benhadji KA, Bridgewater JA; FOENIX-CCA2 Study Investigators. Futibatinib for FGFR2-Rearranged Intrahepatic Cholangiocarcinoma. N Engl J Med. 2023 Jan 19;388(3):228-239. doi: 10.1056/NEJMoa2206834. PMID: 36652354.

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