Gazyvaro + Clb reduced the risk of death by 24% vs rituximab + Clb1
- In an open-label, multicentre, randomised, phase III study in previously untreated CLL patients with comorbidities:
– Gazyvaro + Clb met the primary endpoint of improved PFS vs rituximab + Clb1-3
– Median OS for rituximab + Clb was 73.1 months while Gazyvaro + Clb had yet to reach median OS at 7 years1
Secondary endpoint: OS1
Adapted from Goede et al. 2018.
Treatment with Gazyvaro + Clb significantly prolonged PFS compared with rituximab + Clb 1
- Gazyvaro + Clb reduced the risk of disease progression or death by 51% vs rituximab + Clb (13.2-month absolute improvement in median PFS; HR=0.49; 95% CI, 0.41–0.58; p<0.0001)1:
– Median PFS was 28.9 months for Gazyvaro + Clb vs 15.7 months with rituximab + Clb1
Primary endpoint: PFS1
Adapted from Goede et al. 2018.
- Gazyvaro + Clb reduced the risk of disease progression or death by 82% vs Clb (15.6-month absolute improvement in median PFS; HR=0.18; 95% CI, 0.13–0.24; p<0.001)3
Adapted from Goede et al. 2014.
Adapted from Goede et al. 2018.
*NCT01010061.
†Dose split over two days.
Chemo, chemotherapy; CI, confidence interval; CIRS, cumulative illness rating scale; Clb, chlorambucil; CLL, chronic lymphocytic leukaemia; CrCl, creatinine clearance; FL, follicular lymphoma; G, Gazyvaro; HR, hazard ratio; ITT, intent-to-treat; IV, intravenous; MRD, minimal residual disease; OS, overall survival; PFS, progression-free survival; R, rituximab; TTNT, time to next treatment.
References:
- Goede V et al. Abstract S151 presented at EHA 2018, Stockholm.
- Goede V et al. Leukemia 2015; 29: 1602–1604.
- Goede V et al. N Engl J Med 2014; 370: 1101-1110 and supplementary appendices.
M-GB-00001845
Date of preparation: October 2020