培美替尼治疗肝内胆管癌效果怎么样？

Pemetinib, an oral tablet, has received "breakthrough drug" and "orphan drug" designations as well as "priority review" status, and is approved for the treatment of adult patients with previously treated and unresectable locally advanced or metastatic cholangiocarcinoma who have fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements using an FDA-approved method. Became the first FDA-approved targeted therapy for cholangiocarcinoma. So, how effective is pemetinib in treating intrahepatic cholangiocarcinoma?

FIGHT-202 is an open, multi-center phase II clinical trial that mainly evaluates the safety and efficacy of pemetinib in patients with locally advanced or metastatic cholangiocarcinoma who have failed previous treatments. A total of 146 patients were included in the trial. The trial was divided into three cohorts. Cohort A was for patients with FGFR2 fusion or rearrangement (n=107), cohort B was for patients with FGF/FGFR genetic changes (n=20), and cohort C was for patients without FGF/FGFR genetic changes (n=18). The remaining 1 patient is undecided. All patients received pemetinib 13.5 mg (po, qd), with a 3-week course of treatment (2 weeks of administration followed by 1 week of discontinuation) until radiological examination showed disease progression or intolerable toxicity.

The trial results showed that the ORR of patients in cohort A reached 35.5% (n=38), of which 3 patients achieved complete response (CR), 35 patients achieved PR, and 88 patients had their disease effectively controlled. The DCR was 82%, the DOR was 7.5 months (95% CI: 5.7 ~14.5), and the PFS was 6.9 months (95% CI: 6.2~9.6), 0S reached 21.1 months; the ORR of cohort B and cohort C was 0%. Compared with the other two cohorts, the survival time of patients in cohort A was significantly longer, indicating that pemetinib has a good therapeutic effect on patients with cholangiocarcinoma with FGFR2 fusion or rearrangement.

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