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 + Clb^1-3
  – 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.

At a glance:

OS in the CLL11 study

PFS in the CLL11 study

CLL11 study design

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

CLL11 study design

Learn more about safety and tolerability with Gazyvaro

Adapted from Goede et al. 2014.

CLL11 study design

Download our dosing and administration guide

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:

1. Goede V et al. Abstract S151 presented at EHA 2018, Stockholm.
2. Goede V et al. Leukemia 2015; 29: 1602–1604.
3. Goede V et al. N Engl J Med 2014; 370: 1101-1110 and supplementary appendices.

M-GB-00001845
Date of preparation: October 2020