Nieves Martinez Lago: PROOF 301 Trial Design Challenges in Biomarker-Selected Tumors
Nieves Martinez Lago/LinkedIn

Nieves Martinez Lago: PROOF 301 Trial Design Challenges in Biomarker-Selected Tumors

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

Read the full articles here.

Nieves Martinez Lago

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