Similar safety profiles were observed for both treatment arms1
In the GALLIUM study:
- More patients had grade 3–5 AEs with Gazyvaro than rituximab, but no new safety signals were observed1,2
- The frequency of AEs leading to discontinuation and fatal AEs were similar between treatment groups2
- Safety data in the updated analysis are consistent with those reported in the primary analysis3
Results from GALLIUM, adapted from Hiddemann et al. 2017.
*Includes six patients with fatal AEs that occurred after start of new anti-cancer therapy (4 G + benda + G; 2 R + benda + R).
Selected grade ≥3 AEs of particular interest occurring in >2% of patients in either arm1
Results from GALLIUM, adapted from Hiddemann et al. 2017.
Results from GALLIUM, adapted from Marcus et al. 2017.
†Includes prostate, breast and colon cancers.
Results from GALLIUM, adapted from Roche Data on File.
‡An IRR is any reaction occurring during or within 24 hours of infusion of Gazyvaro or rituximab and considered to be drug-related.
Results from GALLIUM, adapted from Davies et al. 2017.
FACT-Lym Total included: lymphoma specific (15 questions), physical wellbeing (7 questions), functional wellbeing (7 questions), emotional wellbeing (6 questions) and social/family wellbeing (7 questions).5
GALLIUM: study design2
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.2
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).2
Primary endpoint
- 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 study2
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; AE, adverse event; chemo, chemotherapy; CHOP, cyclophosphamide, doxorubicin, vincristine and prednisolone; CR, complete response; CVP, cyclophosphamide, vincristine and prednisolone; DLBCL, diffuse large B-cell lymphoma; EOI, end of induction; FACT-Lym, Functional Assessment of Cancer Therapy-Lymphoma; FDG, fluorodeoxyglucose; FL, follicular lymphoma; FLIPI, Follicular Lymphoma International Prognostic Index; G, Gazyvaro; HR, hazard ratio; IRC, independent review committee; IRR, infusion-related reaction; 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; QoL, quality of life; R, rituximab; SMQ, standardised MedDRA queries; TTNT, time to next treatment.
References:
- Hiddemann W et al. EHA Annual Meeting 2017; abstract S775 and oral presentation.
- Marcus R et al. N Engl J Med 2017; 377(14): 1331–1344.
- Townsend W et al. ASH Annual Meeting 2018; abstract 1597.
- RXUKOBIN00429 Roche Data on File.
- Davies A et al 2017 oral presentation.
Date of preparation: November 2019