Half-Year 2022 Financial and Clinical Trials Update
Hematology franchise: Setting new standards of care
First-in-class EU approvals in 1L DLBCL and 3L+ FL
Ph III (POLARIX) Polivy + R-CHP in 1L DLBCL
Progression free survival (PFS)
POLIVYⓇ
polatuzumab vedotin
Lunsumic
mosunetuzumab
Ph I/II step up dosing (GO29781) Lunsumio in 3L+ FL
Best percentage change from baseline in tumor SPD
100
Best percentage change from baseline in tumor SPD*
Roche
FDA BTD
PFS (%)
100
80
60
40
40
20
Pola-R-CHP (N=440)
R-CHOP (N=439)
+ Censored
HR 0.73 (P<0.02)
95% CI: 0.57, 0.95
#+
0
0
6
12
18
24
30
36
42
Time (months)
Best change (%) from baseline in tumor SPD
80
60
40
20
-60
-80
ཎྱ ཧྨ ༈ 8 ༤ སྙ ༈ ༈ ༈ ཋ
-100
CR¹
ORR¹
60%
80%
.
•
Polivy + R-CHP significantly prolongs PFS with a HR of 0.73 in patients with
intermediate and high risk 1L DLBCL
•
•
Safety of Polivy + R-CHP and R-CHOP comparable
60% CR rate (greater than 14% historical control) with the majority of responses
lasting for at least 18 months
Fixed duration treatment; Favorable tolerability profile suitable for outpatient
setting (CRS low grade and cycle 1)
•
EU approval in 1L DLBCL achieved; Filed in US, Japan and China
•
EU approval in 3L+ FL achieved; Filed in US with priority review granted
•
Ph III (SUNMO) Polivy + Lunsumio in 2L+ SCT ineligible DLBCL FPI in Q2 2022
⚫ Ph III (CELESTIMO) Lunsumio + lenalidomide in 2L+ FL started in Q4 2021
Tilly H. et al, ASH 2021; Budde et al. ASH 2021 (GO29781), 1. ORR by IRF; DLBCL-diffuse large B cell lymphoma; FL-follicular lymphoma; R=Rituxan; CHOP-cyclophosphamide, doxorubicin, vincristine, prednisone;
CHP-cyclophosphamide, doxorubicin, prednisone; CRS-cytokine release syndrome; Polivy in collaboration with Seagen; SCT=stem cell transplant; HR-Hormon receptor; CR-complete response; ORR=overall response rate
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