Income Statement Presentation 2023
Lunsumio & glofitamab: Expanding into earlier lines of treatment
Off-the-shelf, fixed duration with durable responses and manageable safety
Lunsumio
Glofitamab
Product profile
High CR rate and durable responses
• Favorable tolerability with low grade CRS
• No required hospitalization
For outpatient setting, indolent disease (FL) and
elderly/unfit patients
Regimen
Lunsumio
Lunsumio + Polivy
SUNMO
CELESTIMO
Roche
ASH 2022
Key clinical trials
Indication
Phl
Ph II
Ph III
3L+FL
US/EU approved
2L+DLBCL (SCT-ineligible)
Readout 2023/24
2L+FL
IA 2024
r/r CLL
Lunsumio
1L DLBCL (elderly/unfit)
Lunsumio +Polivy
1L DLBCL (elderly/unfit)
Regimen
Indication
Phl
Ph II
Ph III
Lunsumio+lenalidomide
Lunsumio
•
Best in class efficacy potential, high CR rates and
durable responses comparable to CAR-Ts
Well tolerated with low rate of discontinuations
and ICANS; low grade, predictable CRS
glofitamab
3L+ DLBCL
glofitamab
+ GemOx
•
Minimal CRS in 1L DLBCL combined with R + chemo
2L+ DLBCL (SCT-ineligible)
glofitamab+CD19x4-1BBL r/r NHL
STARGLO
For aggressive disease (1L DLBCL, R/R DLBCL, MCL)
glofitamab+CD19xCD28
r/r NHL
ASH 2022
Filed in US (PDUFA 1st July)
Filed in EU
Readout 2023
Glofitamab + Polivy + R-CHP 1L DLBCL
Ph III to initiate in 2023
R/R=relapsed refractory; CRS-cytokine release syndrome; FL-follicular lymphoma; DLBCL-diffuse large B-cell lymphoma; CR-complete response; MCL-mantle cell lymphoma; CAR-T-chimeric antigen receptor T cells;
ICANS-immune effector cell-associated neurotoxicity syndrome; IA=interim analysis; CLL=chronic lymphocytic leukemia; SCT=stem cell transplantation; NHL-non-Hodgkin's lymphoma; GemOx-gemcitabine oxaliplatin;
PDUFA=prescription drug user fee act; R-CHP-rituxan + cyclophosphamide + hydroxydaunorubicin + prednisone
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