Pharma Update
•
Roche
POLIVY
polatuzumab vedotin
Polivy + R-CHP to become a new SOC in 1L DLBCL
POLARIX subgroup data confirm benefit in elderly patients
Polivy + R-CHP first new treatment
in >20 years in 1L DLBCL
Ph III (POLARIX) trial design
Ph III (POLARIX) subgroup of ~280 patients (median age 74 yrs), similar
baseline characteristics compared to ITT
Patients
Pola-R-CHP
Polatuzumab vedotin (1.8mg/kg)*
R-CHP + vincristine placebo
• Previously
untreated DLBCL
R
Cycles 1-6
⚫ Aged 18-80 years
1:1
(1 cycle 21 days)
Rituximab
375mg/m²
• IPI 2-5
Cycles 7 & 8
• ECOG PS 0-2
R-CHOP
R-CHOP++
polatuzumab vedotin placebo
Sustained PFS benefit for Polivy+R-CHP (HR 0.76)
vs. R-CHOP (mFU 39.7 mo)
PFS (probability)
0.8
0.6
1
0.4-
PFS
UHR: 0.64
p=0.042
OS (probability)
0.8
0.6
0.4
1
OS
uHR: 0.74
p=0.296
0.2
-Pola-R-CHP (n=141)
-R-CHOP (n=143)
0.2
-Pola-R-CHP (n=141)
-R-CHOP (n=143)
Unstratified HR: 0.64 (95% CI: 0.41-0.99); p=0.0424
Unstratified HR: 0.74 (95% CI: 0.41-1.31); p=0.2962
0
0
0
6
12
18
24
30
36
0
6
12
18
24
30
36
42
Time (months)
Time (months)
.
Safety comparable with that of R-CHOP
Off-the-shelf and fixed duration treatment
For all treatment settings, including community
Approved in >80 countries
Ph III Columvi+Polivy+R-CHP to initiate in 2023
•
Clinically meaningful improvement in PFS with a uHR of 0.64 for Polivy+R-CHP vs R-CHOP
• OS data immature with a trend for reduction in the risk of death with a uHR of 0.74
•
Similarly high treatment exposure across both treatment arms, highlights the tolerability of the
Polivy+R-CHP regimen in elderly patients
• The safety profile of Polivy+R-CHP in patients aged ≥70 years with 1L DLBCL was generally similar to
that of R-CHOP and consistent with that reported for the overall population aged 18-80 years
Hu B et al., ASCO 2023; Herrera et al. ASH 2022; DLBCL-diffuse large B-cell lymphoma; PFS=progression free survival; OS= overall survival; mFU=median follow-up; ITT-intent-to-treat; R-CHOP=Rituxan + cyclophosphamide
+ doxorubicin + vincristine + prednisone; R-CHP-Rituxan + cyclophosphamide + hydroxydaunorubicin + prednisone; HR-hazard ratio; uHR=unstratified hazard ratio; Cl=confidence interval; SOC-Standard of care
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