Half-Year 2022 Financial and Clinical Trials Update
Hematology franchise development program
Potential first-in-class & best-in-class combinations
100-
80
Ph II (NP30179) glofitamab
in 3L+ DLBCL
Duration of
complete response by IRC
POLIVYⓇ
polatuzumab vedotin
Lunsumic
mosunetuzumab
Most advanced clinical development program
Roche
FL
ANNUAL MEETING
2022 ASCO
DLBCL
3L+
1L
2L+
FDA BTD
1L
Polivy +
R-CHP
R/R
Polivy +
R+ benda
3L+
G+chemo
G+ benda
Lunsumio
glofitamab
Probability
60-
20-
0 1 2 3 4 5 6
Pts at
7
Median DoCR:
NE mo (95% CI: 16.8, NE)
8 9 10 11 12 13 14 15 16 17 18 19 20 21
Time (months)
risk 61 57 55 46 45 36 34 33 28 26 25 23 21 16 14 13 12 10 10 3 1 NE
Lunsumio + CHOP/
Lunsumio+CHP-Polivy
glofit + R-CHOP/
glofit+Polivy-R-CHP
Lunsumio + Polivy
elderly/unfit
glofit + GemOx*
STARGLO
Polivy + Lunsumio*
SUNMO
Primary endpoint met; CR: 39.4% in heavily pre-treated,
highly refractory patients.
CRs achieved were early and durable even after
fixed-duration treatment (max. 12 cycles)
•
•
Glofitamab was well tolerated with low rate of treatment
discontinuations; CRS was mostly low grade
•
•
EU: Filed in 3L+ DLBCL in Q2 2022
Lunsumio +
+ len
CELESTIMO
= Phill
= approved or filed
Lunsumio: Attractive profile for the outpatient setting and across a broad range of indications and settings;
no hospitalization required
Glofitamab: Best-in-class efficacy potential with high CR rates, durable responses and manageable CRS
with fixed treatment duration
Ph III development program in NHL with pivotal read-outs starting in 2023/24: Glofit+ GemOx (STARGLO) in
2L+ DLBCL; Polivy + Lunsumio (SUNMO) in 2L+ DLBCL; Lunsumio + lenalidomide (CELESTIMO) in 2L+ FL
•
Update on novel combinations in 1L DLBCL to be presented at ASH 2022
Dickinson M. et al., ASCO 2022; DLBCL-diffuse large B-cell lymphoma; FL-follicular lymphoma; CR=complete response; CR=*2L+ SCT ineligible DLBCL; R/R-relapsed/refractory; len=lenalidomide; gemOx-gemcitabine + oxaliplatin;
CRS-cytokine release syndrome; glofit=glofitamab; NHL-non-Hodgkin's lymphoma; SCT=stem cell transplant; IRC-independent review committee; Cl=confidence interval; R-CHP-Rituxan, cyclophosphamide,
hydroxydoxorubicin, prednisone; CHOP-cyclophosphamide, doxorubicin, vincristine, and prednisone; ASH-American Society of Hematology
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