Half-Year 2022 Financial and Clinical Trials Update
Glofitamab (CD20-TCB, RG6026)
Bispecific anti-CD20/CD3 antibody engaging T and B cells simultaneously
Indication
Non-Hodgkin's lymphoma (NHL)
2L+ SCT-ineligible DLBCL
Roche
Phase/study
# of patients
Design
Phase lb
Part I: 15-60
Part II: ~66-104
■ Part I: Dose-finding for the combination of glofitamab plus G/R-CHOP in r/r
indolent NHL
Part II: Dose expansion glofitamab plus G/R-CHOP or R-CHOP in 1L DLBCL
Part III: Glofitamab plus R-CHP plus Polivy
Phase III
STARGLO
N=270
ARM A: Glofitamab plus gemcitabine and oxaliplatin, followed by up to 4
cycles of glofitamab monotherapy
ARM B: Rituxan in combination with gemcitabine and oxaliplatin
A single dose of Gazyva will be administered 7 days prior to the first dose
of glofitamab
Primary endpoint
Status
CT Identifier
Safety
☐
Part I: FPI Q1 2018
Part II: FPI Q1 2021
Data presented at ASH 2021
NCT03467373
Overall survival
"
FPI Q1 2021
NCT04408638
DLBCL-diffuse large B cell lymphoma; SCT=stem cell transplant; CHOP-cyclophosphamide, doxorubicin, vincristine and prednisone; R=Rituxan/MabThera; G-Gazyva; NHL-Non-Hodgkin's lymphoma; r/r-Relapsed or refractory
ASH-American Society of Hematology
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OncologyView entire presentation