Income Statement Presentation 2023
Polivy in 1L DLBCL: First new treatment in >20 years
Included in NCCN guideline as category 1*; NICE reimbursement obtained**
Ph III (POLARIX) results
PFS strongly predicts OS outcomes¹
100
80
PFS (%)
P40
60-
20 3-year APFS: 7.7%
HR 0.76
95% CI: 0.60-0.97
0
0
No. of patients at risk
Pola-R-CHP
R-CHOP
PFS
Pola-R-CHP (N=440)
R-CHOP (N=439)
+ Censored
12
24
36
48
55
Time (months)
440
439
405
390
354
331
331
300
313
284
242
222
103
94
66
0
0
59
2
1
ASH 2022
A 0.31
n = 25
0.2-
r = 0.772
Log HR (OS)
0.1-
0-
-0.1-
-0.2-
-0.3-
-0.4+
T
-0.4 -0.3 -0.2 -0.1 0 0.1
Log HR (PFS)
0.2
•
Updated Ph III (POLARIX) results: median follow-up 39.7 months demonstrated sustained PFS benefit in Pola-R-CHP (HR 0.76) vs. R-CHOP
• PFS is a valid endpoint recognized by all major health authorities to demonstrate efficacy benefit in 1L DLBCL
•
•
Polivy in 1L DLBCL has significant potential to decrease cost for progressive disease, due to fewer patients progressing
Approved in EU/UK/Japan/China/Canada, overall >50 countries; US filing: ODAC on Mar 9th and PDUFA date set for Apr 2nd
Roche
POLIVYⓇ
polatuzumab vedotin
Polivy in collaboration with Seagen; *NCCN guidelines for B-Cell Lymphomas (V1.2023); **NICE: Polatuzumab vedotin in combination for untreated diffuse large B-cell lymphoma [ID3901]; 1 Shi Q, Schmitz N, Ou FS, et al. Progression free survival as a
surrogate end point for overall survival in first line diffuse large B cell lymphoma: An individual patient level analysis of multiple randomized trials (SEAL). J Clin Oncol.2018;36(25):2593 2602; DLBCL-diffuse large B-cell lymphoma; PFS=progression free
survival; OS-overall survival; R-CH(O)P=Rituxan + cyclophosphamide + doxorubicin + (vincristine) + prednisone; HR-hazard ratio; NCCN=national comprehensive cancer network; NICE=national institute for health and care excellence
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