Roche Pharmaceutical Development and Sales Overview
Glofitamab (CD20-TCB, RG6026)
Bispecific anti-CD20/CD3 antibody engaging T and B cells simultaneously
Indication
Relapsed or refractory Non-Hodgkin's lymphoma (NHL)
Roche
Phase/study
# of patients
Design
Primary endpoint
Status
CT Identifier
Phase I
N=700
Cohort 1: Single-agent dose escalation study
Initial dose escalation
Expansion cohort in r/r DLBCL
Expansion cohort in r/r FL
All patients will receive pretreatment with a single
dose of Gazyva (1000mg)
Cohort 2: Glofitamab plus Gazyva (i.e. continuous
treatment with Gazyva)
Efficacy, safety, tolerability and pharmacokinetics
FPI Q1 2017
Data presented at ASH 2018, ICML and ASH 2019;
EHA and ASH 2020; ASCO, EHA, ICML and ASH 2021;
ASCO and EHA 2022
Data published online June 2021 J Clin Oncology
39:18:1959-1970
Filed in EU April 2022
NCT03075696
Phase lb
N=140
Dose escalation and expansion
ARM A: Glofitamab plus Tecentriq
ARM B: Glofitamab plus Polivy
Phase I
N=18-36
Glofitamab SC
Part 1 dose escalation
Safety
"
Safety
ARM A: FPI Q2 2018
FPI Q3 2021
"
Data presented at ASH 2019 and ASH 2021
ARM B: FPI Q4 2020
NCT03533283
ISRCTN17975931
DLBCL=diffuse large B cell lymphoma; FL=Follicular lymphoma; r/r-Relapsed or refractory; SC=subcutenous; ASCO-American Society of Clinical Oncology; ASH-American Society of Hematology; EHA-European Hematology
Association; ICML-International Conference on Malignant Lymphoma
109
OncologyView entire presentation