Roche Pharmaceutical Development and Sales Overview
Lunsumio (mosunetuzumab, CD20 x CD3, RG7828)
Bispecific anti-CD20/CD3 antibody engaging T and B cells simultaneously
Indication
3L+ FL, 3L+ DLBCL & other relapsed or refractory
NHL
1L DLBCL
Relapsed or refractory DLBCL
Phase/study
# of patients
Phase I/II
Phase Ib/II
N=746
"
Dose escalation study of Lunsumio as single agent
and in combination with Tecentriq
"
N=160
Design
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Primary endpoint
Expansion cohorts for r/r FL, r/r DLBCL and SC in
r/r NHL
Safety, tolerability, dose/schedule, PK and
response rates
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Lunsumio plus CHOP
Lunsumio plus CHP plus Polivy
Lunsumio plus CHP-Polivy vs Rituximab plus
CHP-Polivy
Safety/tolerability and response
Phase Ib/II
N=262
Lunsumio plus Polivy, randomised cohorts
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ARM A: Lunsumio SC plus Polivy
☐
ARM B: Rituximab plus Polivy
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Safety/tolerability and response
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Data in r/r NHL presented at ASH 2018 and 2019,
and in r/r FL at ASH 2020 and ASH 2021
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FPI Q1 2019
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FPI Q3 2018
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BTD granted by FDA Q2 2020
Data for Lunsumio plus CHOP presented at
ASH 2020
Initial data presented at ASCO and ASH
2021
SC cohort FPI Q2 2021
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Status
Filed in EU and rolling submission in US Q4 2021
Approved in EU Q2 2022
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Filed in US (priority review) Q2 2022
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Data published in J. Clin. Oncol. 40(5)481-491 and
in the Lancet July 2022: doi.org/10.1016/S1470-
2045(22)00335-7
CT Identifier
NCT02500407
NCT03677141
NCT03671018
FL-follicular lymphoma; DLBCL-diffuse large B cell lymphoma; r/r-relapsed/refractory; NHL-non-Hodgkin's lymphoma; R=Rituximab; SC=subcutaneous; CHOP-cyclophosphamide, doxorubicin, vincristine, and prednisone;
CHP-cyclophosphamide, doxorubicin, and prednisone); PK-Pharmacokinetics; BTD=Breakthrough Therapy Designation; ASH-American Society of Hematology; ASCO-American Society of Clinical Oncology
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Roche
OncologyView entire presentation