- No new safety signals were observed2
Summary of AEs reported in ≥5% of patients with relapsed or refractory NHL that had an incidence ≥2% in the Gazyvaro plus bendamustine followed by Gazyvaro monotherapy arm vs the bendamustine arm2
- In cycle 1, the incidence of IRRs was highest on day 1 (38%) and gradually decreased on days 2*, 8, and 15 (25%, 7%, and 4%, respectively)3
- During induction, grade 3–4 IRRs were observed in 10.8% of patients in the Gazyvaro + bendamustine arm vs 5.6% of patients in the bendamustine arm3
- Four patients (3%) experienced an IRR leading to discontinuation of Gazyvaro + bendamustine2
Rituximab-refractory FL (GADOLIN): patients experiencing IRRs3†
Results from GADOLIN, adapted from Roche Data on File.
*Day 2 consisted of bendamustine only.
†An IRR was defined as any reaction occurring during or within 24 hours of infusion of Gazyvaro or bendamustine, and is considered to be drug-related.
a81% of patients had FL.2
cEach dose of Gazyvaro induction was 1000 mg and was administered on days 1, 8 and 15 of cycle 1, and day 1 of cycles 2–6. Bendamustine, in combination with Gazyvaro, was administered on days 1 and 2 for cycles 1–6 at 90 mg/m2/day. Each cycle was 28 days.2
dBendamustine monotherapy was administered on days 1 and 2 of cycles 1–6 at 120 mg/m2/day. Different doses of bendamustine were used in each treatment arm as recommended by an international consensus panel of haematologists, guided by efficacy, safety and tolerability principles.2
eEach dose of Gazyvaro maintenance was 1000 mg and was administered on day 1 of each cycle (up to 12 cycles).2
AE, adverse event; Benda, bendamustine; BOR, best overall response; CLL, chronic lymphocytic leukaemia; CR, complete response; DoR, duration of response; FL, follicular lymphoma; G, Gazyvaro; IRC, independent review committee; IRR, infusion-related reaction; NHL, non-Hodgkin lymphoma; OS, overall survival; PFS, progression-free survival, PR, partial response; SD, stable disease.
- Gazyvaro Summary of Product Characteristics.
- Sehn LH et al. Lancet Oncol 2016; 17:1081–1093.
- M-GB-00000419 Roche Data on File.
Date of preparation: June 2020