Nieves Martinez Lago, Specialist in the Field (FEA) of Medical Oncology at University Hospital Complex of Santiago de Compostela, shared a post on X:
“PROOF 301 – FGFR2-rearranged
- CCA Infigratinib vs GC (phase III).
- PFS (BICR) 7.4 vs 8.0 mo.
- ORR 37.9% vs 15.8%.
- Grade ≥3 AEs 79% vs 59%.
Early termination (poor accrual) – no definitive conclusions.
Trial design challenges in rare, biomarker-selected tumors.”
Title: Phase III trial of infigratinib versus gemcitabine/cisplatin in adults with advanced cholangiocarcinoma with FGFR2 gene fusion or rearrangement: results and reflections on early termination of PROOF 301
Authors: G.K. Abou-Alfa, I. Borbath, S. Roychowdhury, L. Goyal, A. Lamarca, T. Macarulla, R.T. Shroff, D.-Y. Oh, C. Tamaş, D.M. Savastano, D.F. van Veenhuyzen, C. Xu, E. Freas, J. Solanas, M.M. Javle

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