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Final analysis of the GAIA/CLL13 trial: Venetoclax combinations vs chemoimmunotherapy in CLL
A total of 926 patients were randomized to receive GV (n = 229), GIV (n = 231), RV (n = 237) or CIT (n = 229). The primary endpoints were undetectable measurable residual disease at 15 months and PFS. At the final analysis, the median follow-up was 63.8 months. |
Key learnings |
At 15 months, 66.2%, 60.03%, 23.6%, and 22.7% of patients in the GIV, GV, RV, and CIT groups achieved NGS MRD (×10−6), respectively. In all groups, PFS was prolonged in patients with uMRD level of >10−6 vs <10−6. |
The 5-year PFS rates were highest in the GIV group compared to the GV, RV, and CIT groups (81.3%, 69.8%, 57.4%, and 50.7%, respectively). GIV demonstrated superior PFS compared to GV (HR, 0.61; p = 0.005), RV (HR, 0.35; p < 0.001), and CIT (HR, 0.34; p < 0.001). |
Unmuted vs mutated IGHV was an independent prognostic factor for shorter PFS in GIV (HR, 2.07; p = 0.02), GV (HR, 2.68; p < 0.001), RV (HR, 2.17; p < 0.001), and CIT (HR, 3.55; p < 0.001) groups. |
The incidence of SPM (2.2 vs 1.2 vs 1.5 vs 2.0 events/1000 patient-months) was higher in the GIV group compared with the GV, RV, and CIT groups, while the incidence of NMSC (0.7 vs 1.1 vs 1.1 vs 2.2 events/1000 patient-months) and Richter’s syndrome (0.2 vs 0.6 vs 0.5 vs 0.5 events/1000 patient-months) was lower. |
GIV and GV combinations showed superior PFS compared to CIT and RV. However, factors like tolerability, QoL, and OS should be considered when comparing GIV and GV. |
CIT, chemoimmunotherapy; GIV, Obinutuzumab + ibrutinib + venetoclax; GV, Obinutuzumab + venetoclax; HR, hazard ratio; IGHV, immunoglobulin heavy chain variable; MRD, measurable residual disease; NGS, next-generation sequencing; NMSC, non-melanoma skin cancer; OS, overall survival; PFS, progression-free survival; QoL, quality of life; RV, rituximab + venetoclax; SPM, secondary primary malignancy; uMRD, undetectable measurable residual disease.
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