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ASCO GI 2024 | PROOF 301: infigratinib vs. gem/cis in patients with CCA with an FGFR2 gene fusion/rearrangement

Ghassan K. Abou-Alfa, MD, MBA, Memorial Sloan Kettering Cancer Center, New York, NY, presents findings on infigratinib as a potential frontline treatment for FGFR2 gene fusion/translocations in cholangiocarcinoma (CCA). The PROOF 301 (NCT03773302) Phase III trial, comparing infigratinib to gemcitabine + cisplatin, was prematurely halted, and this report covers the accrued patient data before termination. Of the 48 enrolled patients, 29 received infigratinib, and 19 received gem/cis. Preliminary results indicate a median progression-free survival (PFS) of 7.4 months with infigratinib versus 8.0 months with gem/cis. Infigratinib demonstrated a higher overall response rate (37.9%) compared to gem/cis (15.8%). Despite early termination, the study suggests infigratinib’s potential efficacy in FGFR2-rearranged CCA. This interview took place at the 2024 ASCO Gastrointestinal (GI) Cancers Symposium in San Francisco, CA.

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