Summary

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• This summary is based on the review of one randomized controlled trial(s). ^[1]
• The objective response rate (ORR) in patients with unresectable or metastatic FGFR2 fusion-positive or rearrangement-positive intrahepatic cholangiocarcinoma was 42% (43 out of 103 patients), with a 95% confidence interval of 32% to 52%.
• Median progression-free survival (PFS) was 9.0 months, and median overall survival (OS) was 21.7 months.
• The effectiveness of the treatment was consistent across subgroups, including heavily pretreated patients, older adults, and those with co-occurring TP53 mutations.
• Common grade 3 treatment-related adverse events included hyperphosphatemia (30%), increased aspartate aminotransferase (7%), stomatitis (6%), and fatigue (6%).
• Treatment-related adverse events led to permanent discontinuation in 2% of patients, with no treatment-related deaths reported.
• The population consisted of patients with unresectable or metastatic FGFR2 fusion-positive or rearrangement-positive intrahepatic cholangiocarcinoma who had disease progression after one or more lines of systemic therapy (excluding FGFR inhibitors), with consistent effectiveness observed across subgroups, including heavily pretreated patients, older adults, and those with co-occurring TP53 mutations.