How well does pemazyre(pemigatinib) work?

Clinical trials are an important means of evaluating the safety and efficacy of drugs, and are of great significance for the research and development and market approval of new drugs. The following will introduce the research progress and results of pemigatinib in clinical trials.

Clinical Trials of Pemigatinib for Cholangiocarcinoma Treatment

1. Trial Design

FIGHT-202 (NCT02924376) was a multicenter, open-label, single-arm trial that evaluated the efficacy of pemigatinib in 107 patients with locally advanced unresectable or metastatic cholangiocarcinoma. These patients had disease progression during or after at least one prior treatment and harbored FGFR2 gene fusions or non-fusion rearrangements.

2. Trial Outcome Measures

The primary efficacy endpoints were the overall response rate (ORR) and duration of response (DoR) as determined by an Independent Review Committee (IRC) in accordance with RECIST v1.1.

3. Trial Results

(1) The overall response rate (ORR) was 36%, which included a complete response rate of 2.8%.

(2) The median duration of response (DoR) was 9.1 months, and 18% of patients had a duration of response exceeding 12 months.