Comprehensive analysis of the clinical effects of pemetinib/pemetinib

The U.S. Food and Drug Administration (FDA has accelerated the approval of pemigatinib for the treatment of adult patients with unresectable locally advanced or metastatic cholangiocarcinoma who have been confirmed to have FGFR2 fusions or other rearrangements by FDA-approved testing methods and who have undergone at least one treatment. The approval was based on results from a multicenter, open-label, single-arm clinical trial called FIGHT-202.

In the FIGHT-202 trial, a total of 107 patients with locally advanced unresectable or metastatic cholangiocarcinoma received pemetinib. These patients had disease that had progressed during or after at least one prior treatment, and all had FGFR2 gene fusions or rearrangements. The treatment regimen consists of oral administration of 13.5 mg of pemetinib daily for 14 days followed by 7 days off. The safety assessment was based on data from a total of 466 patients, 146 of whom had cholangiocarcinoma and received the recommended dose.

The primary endpoints for efficacy evaluation were overall response rate (ORR) and duration of response (DOR) as determined by an independent review committee usingRECIST 1.1 criteria. The trial results showed that the ORR reached 36% (95% confidence interval 27-45%), and the median DOR was 9.1 months. This shows that pemetinib has a significant effect in inhibiting tumor growth and spread, allowing some patients to have their disease stabilized or partially remitted. Overall survival was significantly longer in the treatment group compared with the placebo group.

In summary, pemetinib, as an innovative drug for patients with cholangiocarcinoma with FGFR2 fusion or other rearrangements, has demonstrated significant therapeutic effects in clinical trials. However, adverse reactions during its use also require sufficient attention.