GADOLIN: Studied in a Rituximab-Refractory Population and Approved
in R/R FL
This Phase III randomized controlled trial was designed to establish the clinical benefit in terms of progression-free survival (PFS) of GAZYVA (obinutuzumab) in combination with bendamustine followed by GAZYVA (obinutuzumab) monotherapy, compared to bendamustine alone 1,2
- Primary endpoint: PFS assessed by an independent review committee (IRC)
Secondary endpoints: PFS as assessed by investigator, best
overall response (complete response [CR] and partial response [PR]),
duration of response, and overall survival
aPatients were stratified according to rituximab
product-refractory type (refractory to prior rituximab product
monotherapy vs rituximab product in combination with chemotherapy)
and the number of prior therapies (≤2 versus >2).
bEach dose of GAZYVA in Cycles 1-6 was 1,000 mg IV and was administered on Days 1, 8, and 15 in Cycle 1; and Day 1 of Cycles 2-6. Cycles 1-6 were 28 days in duration each.
cBendamustine, in combination with GAZYVA, was administered on Days 1 and 2 for Cycles 1-6 at 90 mg/m2/day IV.
dBendamustine alone was administered on Days 1 and 2 of Cycles 1-6 at 120 mg/m2/day IV.
ePatients in the GAZYVA + bendamustine arm who did not have disease progression (patients with a CR, PR, or stable disease [SD]) at the end of the 6 cycles continued receiving GAZYVA monotherapy for 2 years.
fEach dose of GAZYVA monotherapy was 1,000 mg IV and was administered every 2 months for 2 years unless disease progression occurred during the treatment. At the time of interim analysis, 114 patients started GAZYVA monotherapy.