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December 8, 2025Blood

MRD-guided ibrutinib plus venetoclax improves outcomes in CLL patients with TP53, ATM, or NOTCH1 aberrations compared to ibrutinib and FCR: Results from the Phase III NCRI FLAIR trial

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Authors

JSJane ShinglesNWNichola WebsterARAndy C. Rawstron

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Overview

Phase III trial shows MRD-guided ibrutinib plus venetoclax improves progression-free survival in CLL patients with TP53 and other aberrations, indicating enhanced treatment effectiveness.

Key Points

  • To assess the impact of baseline genetic aberrations on progression-free survival in CLL patients receiving MRD-guided ibrutinib plus venetoclax compared to standard therapies.
  • Ongoing Phase III, multicentre, randomised, controlled, open label trial (FLAIR) comparing I+V, I, and FCR
  • Analysis of baseline genetic aberrations and their impact on progression-free survival
  • Chromosomal abnormalities detected using FISH; genetic mutations assessed with targeted sequencing.
  • 1172 patients randomized to I+V, I, or FCR with improved PFS in genetic aberration groups
  • Significant PFS improvement for TP53, ATM, and NOTCH1 mutations treated with I+V compared to I and FCR
  • 95% progression-free survival for specific aberration groups using I+V therapy over 5 years.

Cite This Study

Shingles et al. (2025) studied this question.

synapsesocial.com/papers/69362f4e4fa91c937236d8d1https://doi.org/10.1182/blood-2025-679
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  1. 1FCR-I/iven combination for CLL: «Cheap but fierce»2025
  2. 2Patient‐reported health‐related quality of life in previously untreated chronic lymphocytic leukaemia: Results from the randomised phase 3 FLAIR trial comparing ibrutinib–rituximab versus fludarabine–cyclophosphamide–rituximab2026
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  4. 4Impact of prognostic mutations on outcomes with fixed-duration acalabrutinib-venetoclax combinations versus chemoimmunotherapy: An exploratory analysis from AMPLIFY2025 · 1 citations
  5. 5Acquired Bruton's tyrosine kinase mutations in patients treated on the ibrutinib and rituximab, ibrutinib alone, and ibrutinib and venetoclax arms of the national multi-centre Phase III FLAIR study in previously untreated CLL patients2025 · 3 citations