In the pivotal CLL11 study, infection rates were similar in all three treatment groups1
- Gazyvaro + Clb was associated with a higher incidence of neutropenia than rituximab + Clb or Clb monotherapy1
Adapted from Goede et al. 2014 (appendix).
*AEs of any grade occurring in ≥10% of patients in any treatment group.
Grade ≥3 AEs: Gazyvaro + Clb vs rituximab + Clb1
- Overall increased rates of grade 3-5 AEs were observed with Gazyvaro + Clb vs rituximab + Clb; however, rates of serious AEs and infection were comparable between the two treatment arms1
Grade ≥3 AEs occurring in ≥3% of patients†
Adapted from Goede et al. 2014.
†Grade ≥3 AEs occurring in ≥3% of patients in any treatment group.
‡ Infections comprised nasopharyngitis, bronchitis, pneumonia, upper respiratory tract infection, urinary tract infection, respiratory tract infection and oral herpes.
First 1000 mg infused: 65% of patients experienced IRRs with Gazyvaro2
- Grade 3 or 4 reactions occurred in 20% of patients2
Subsequent infusions: IRRs also occurred2
- The incidence of IRRs with subsequent infusions was 3% with the second 1000 mg and <1% thereafter2
- There were no grade 3 or 4 IRRs reported after the first 1000 mg infused2
Incidence of IRRs by cycle2
Open-label, randomised phase III study in previously untreated CLL patients with coexisting medical conditions*
Adapted from Goede et al. 2018.
†Dose split over two days.
AE, adverse event; Chemo, chemotherapy; CI, confidence interval; CIRS, cumulative illness rating scale; Clb, chlorambucil; CLL, chronic lymphocytic leukaemia; CrCl, creatinine clearance; C, cycle; D, day; FL, follicular lymphoma; FLIPI, Follicular Lymphoma International Prognostic Index; G, Gazyvaro; HR, hazard ratio; IRR, infusion-related reaction; ITT, intent-to-treat; IV, intravenous; MRD, minimal residual disease; OS, overall survival; PFS, progression-free survival; POD24, progression of disease within 24 months post-randomisation; R, rituximab, TTNT, time to next treatment.
- Goede V et al. N Engl J Med 2014; 370: 1101-1110 and supplementary appendices.
- Gazyvaro Summary of Product Characteristics.
Date of preparation: November 2019