Results from GALLIUM, adapted from Marcus et al. 2017.
A third fewer Gazyvaro patients were likely to progress or die within 3 years vs rituximab1
- In the GALLIUM study, Gazyvaro provided a significant improvement in PFS after 4 years vs rituximab2
– 78% of patients receiving Gazyvaro did not die or progress vs 67.2% of patients receiving rituximab2*
* GALLIUM was not powered to show PFS benefit at 4 years.2
- NICE recommends Gazyvaro as a cost-effective option compared with rituximab/rituximab biosimilar in untreated advanced FL patients with a FLIPI score ≥24
- During longer-term follow-up, Gazyvaro provided greater improvements in PFS vs rituximab in patients with FLIPI scores ≥2 than in the ITT population2,3
- In a retrospective sub-analysis of the GALLIUM study, in patients with FLIPI scores ≥2:
– Gazyvaro increased 4-year PFS rates by 13.8% compared to rituximab (35% risk reduction; HR=0.65; 95% CI, 0.52–0.82)3
Investigator-assessed PFS in patients with FLIPI scores ≥2 (median follow-up: 57 months)3
Results from GALLIUM, adapted from Launonen et al. 2019.
Key to the significance of the results, the GALLIUM study was designed in collaboration with the NCRI (UK), GLSG (Germany) and the OSHO (Germany) to investigate Gazyvaro vs rituximab, where each arm was combined with chemotherapy in first-line advanced FL.1
The sample size was calculated to give the trial 80% power to detect a difference in PFS that corresponded to a 26% lower risk of progression, relapse or death with Gazyvaro vs rituximab (HR=0.74) at α=0.05 (two-sided log-rank test).1
- Investigator-assessed PFS
- IRC-assessed PFS, overall survival, overall response rate at EOI (+/- FDG-PET), event-free survival, disease-free survival, duration of response, TTNT, safety
- POD24, PET-CR, MRD, DLBCL transformation, PK, PD
An open-label, multicentre, randomised phase III study1
aCHOP or CVP (8 cycles) or bendamustine (6 cycles). Anti-CD20 + CHOP was administered for the first 6 cycles, with anti-CD20 immunotherapy administered alone for the 2 remaining cycles.
1L, first-line; Chemo, chemotherapy; CI, confidence interval; CR, complete response; DLBCL, diffuse large B-cell lymphoma; EOI, end of induction; FDG, fluorodeoxyglucose; FL, follicular lymphoma; FLIPI, Follicular Lymphoma International Prognostic Index; G, Gazyvaro; HR, hazard ratio; IRC, independent review committee; ITT, intent-to-treat; MRD, minimal residual disease; PD, pharmacodynamics; PET, positron emission tomography; PFS, progression-free survival; PK, pharmacokinetics; POD24, progression of disease within 24 months post-randomisation; PR, partial response; R, rituximab; TTNT, time to next treatment.
- Marcus R et al. N Engl J Med 2017; 377(14): 1331–1344.
- Townsend W et al. ASH Annual Meeting 2018; abstract 1597.
- Launonen A et al. ICML annual meeting 2019; abstract 342.
- NICE. Obinutuzumab for untreated advanced follicular lymphoma: Technology appraisal guidance [TA513]. Available at: https://www.nice.org.uk/guidance/ta513. Last accessed September 2019.
Date of preparation: November 2019