IGHV status remains one of the best-established predictive biomarkers to date and a key factor in patient stratification.[2][3]
Adapted from Eichhorst B, et al. 2021.[1]
[a]CIT as alternative treatment, only if reasons against treatment with targeted therapies or non-availability. [b]BR might be considered alternatively in patients above the age of 65 years. [c]If available. [d]If approved and available.[1]
CIT=chemoimmnotherapy; CLBO=chlorambucil, obinutuzumab; FCR=fludarabine, cyclophosphamide and rituximab.
See what opinion leaders have to say about the role IGHV status can play in tailoring treatment to achieve optimum results in newly diagnosed CLL:
CLL10: Progression-free survival by IGHV status with fludarabine, cyclophoshamide and rituximab (FCR)[7]*
Adapted from Eichhorst B, et al. 2016.[7]
CLL10: Progression-free survival by IGHV status with bendamustine + rituximab (BR)[7]*
Adapted from Eichhorst B, et al. 2016.[7]
RESONATE-2: Ibrutinib vs chlorambucil progression-free survival by IGHV status at up to 7 years[8]†
Adapted from Ghia P, et al. 2021.[8]
CLL14: Progression-free survival by IGHV status with venetoclax + obinutuzumab (V+O) vs chlorambucil + obinutuzumab (C+O)[9]‡
Adapted from Al-Sawaf O, et al. 2021.[9][12]
≥98% of nucleotide identity to germline is required to achieve uIGHV classification.[13]
97–97.9% of nucleotide identity to germline is considered borderline.[13]
This subset is formally classified as mIGHV, but caution is warranted[13]
<98% of nucleotide identity to germline is required to achieve mIGHV classification.[13]
Today's decision shapes tomorrow.
*CLL10 was a randomised, open-label, international, phase III study of FCR vs. BR in fit, previously untreated CLL patients without del(17p) mutation (n=561).[7]
†RESONATE-2 is a phase III, open-label, multicentre, international, randomised study investigating the long-term efficacy and safety of ibrutinib vs chlorambucil in previously untreated patients with CLL/SLL (up to 7 years of follow-up, (n=269)).[8]
‡CLL14 is a randomised trial comparing the efficacy and safety of a combined regimen of obinutuzumab and venetoclax vs obinutuzumab and chlorambucil in previously untreated patients with CLL (n=432) and coexisting medical conditions.[9]
BR=bendamustine, rituximab; CI=confidence interval; CIT=chemoimmunotherapy; CLBO=chlorambucil, obinutuzumab; CLL=chronic lymphocytic leukaemia; C+O=chlorambucil, obinutuzumab; IGHV=immunoglobulin heavy chain variable; ERIC=European Research Initiative on CLL; ESMO=European Society for Medical Oncology; FCR=fludarabine, cyclophosphamide and rituximab; HR=hazard ratio; iwCLL=International Workshop on Chronic Lymphocytic Leukemia; m/uIGHV=mutated/unmutated IGHV; NR=not reached; PCR=polymerase chain reaction; PFS=progression-free survival; V+O=venetoclax, obinutuzumab.