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培米替尼治疗胆管癌的效果

Author: Medicalhalo
Release time: 2025-10-19 11:44:20

The U.S. FDA granted accelerated approval for the treatment of adult patients with previously treated unresectable locally advanced or metastatic cholangiocarcinoma harboring FGFR2 fusions or other rearrangements.

The effect of pemetinib in the treatment of cholangiocarcinoma:

In a study of 67 patients with at least 6 months of follow-up, investigators documented an objective response rate of 37.3% (95% CI, 25.8-50.0). One patient (1.5%) had a complete response and 24 (35.8%) had a partial response. Pemetinib is an oral small molecule inhibitor of FGFR1-4. FGFR2 fusions occur in 10% to 20% of iCCA patients. The 5-year survival rate for patients with these alternations is 24%. There is no standard treatment for advanced disease after first-line chemotherapy.

Responses were durable, lasting an average of 8.3 months, with 37% of patients continuing treatment. The researchers observed objective responses among patient subgroups, independent of the number of prior treatment regimens and patients with concurrent genetic alterations in the TP53, IDH1 and PI3K genes. The disease control rate was 82.1% - (95% CI, 70.8-90.4). Median response time was 2.5 months (range 1.4-2.7). Median duration of response (DOR) was 8.3 months (95% CI, 6.2 not evaluable).

Median progression-free survival (PFS) was 7.2 months (95% CI, 4.0-15.2). At 6 months, PFS was 61% (95% CI, 47.5-72.0) and overall survival (OS) was 86% (95% CI, 74.7-92.4).

In an interim analysis of patients with intrahepatic cholangiocarcinoma (iCCA) with FGFR2 fusions/rearrangements, it was shown to be effective and tolerable.

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