Roche Pharmaceutical Development and Sales Overview
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
Phase/study
# of patients
Phase lb
Part I: 15-60
Phase III
STARGLO
N=270
Roche
Part II: ~66-104
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Part I: Dose-finding for the combination of glofitamab plus G/R-CHOP in
r/r indolent NHL
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Part II: Dose expansion glofitamab plus G/R-CHOP or R-CHOP in 1L
DLBCL
Design
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Part III: Glofitamab plus R-CHP plus Polivy
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
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Part I: FPI Q1 2018
Part II: FPI Q1 2021
Data presented at ASH 2021
NCT03467373
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Overall survival
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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
110
OncologyView entire presentation