(Cholangiocarcinoma) Is Pemigatinib Effective?
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This article is a summary of international medical information and is not medical advice; it cannot replace the diagnosis or treatment plan of your attending physician. The medical technologies, drug information and clinical data presented here are compiled from public literature and official statements of major Japanese medical institutions; the applicability and outcome of any therapy vary with each patient and must be assessed individually by a qualified physician.
On February 14, 2022, Vivek Subbiah et al. from The University of Texas MD Anderson Cancer Center published results from the FIGHT-101 Phase 1/2 clinical trial in the medical journal Annals of Oncology, evaluating the efficacy and safety of the FGFR inhibitor Pemigatinib in patients with advanced malignant tumors harboring FGF/FGFR gene alterations.
The FIGHT-101 Phase 1/2 clinical trial enrolled patients with advanced malignant tumors harboring FGF/FGFR gene alterations (N=128) and divided them into two groups: one group received Pemigatinib 1–20 mg once daily for two weeks followed by one week off (N=70), and the other group received Pemigatinib 1–20 mg once daily on a continuous schedule (N=58). The primary endpoint was dose-limiting toxicity.
The results showed that no dose-limiting toxicity was confirmed in the primary endpoint. The recommended Phase 2 dose was determined to be Pemigatinib 13.5 mg once daily. The most commonly observed adverse event was hyperphosphatemia in 75.0% of patients (Grade 3 or higher: 2.3%), with fatigue being the most frequent Grade 3 or higher adverse event at 10.2%.
In terms of efficacy, 12 patients achieved partial responses, including 5 with cholangiocarcinoma and one each with head and neck cancer, pancreatic cancer, gallbladder cancer, cervical cancer, urothelial cancer, non-small cell lung cancer, and pilocytic astrocytoma. The median duration of treatment was 7.3 months.
Based on the FIGHT-101 trial results, Vivek Subbiah et al. stated: "Antitumor responses were confirmed in patients with advanced malignant tumors harboring FGF/FGFR gene alterations treated with the FGFR inhibitor Pemigatinib. These results have supported subsequent Phase 2/3 clinical trials in cholangiocarcinoma and other multiple cancer types."
Source: https://www.annalsofoncology.org/article/S0923-7534(22)00110-7/fulltext
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