POLIVY® + R-CHP: Superior PFS vs R-CHOP in the ITT Population1,15
PFS was calculated in a time-to-event analysis, in which investigator-assessed disease progression or disease relapse or death from any cause were counted as events.
Estimated median follow-up of 24.7 months in both arms combined.
†No statistical hypothesis testing was performed for 2 year PFS data. No formal inferences may be drawn from these landmark analyses.
‡Based on specific disease, context of use, magnitude of the effect, the disease setting, location of metastatic sites, available therapy, the risk-benefit relationship, and the clinical consequences of delaying or preventing progression in key disease sites (e.g., delay of new lesions in the brain or spine) or delaying administration of more toxic therapies.
POLIVY + R-CHP (n=440) | R-CHOP (n=439) | |
---|---|---|
Patients with event, n (%) | 112 (26) | 138 (31) |
HR [95% CI] | 0.75 [0.58, 0.96] | |
p-value‖ | 0.0244 |
§Modified EFS is defined as the time from randomization to the earliest occurrence of disease progression or relapse, death, an efficacy finding that led to non-protocol specified lymphoma treatment, or biopsy positive for residual disease.
‖Stratified log-rank test, with a two-sided significance boundary of 0.05. The hierarchical testing order was PFS, modified EFS, and then CR rate and overall survival.
POLIVY + R-CHP (n=440) | R-CHOP (n=439) | |
---|---|---|
Objective response rate, % [95% CI] | 86 [82, 89] | 84 [80, 87] |
CR rate, % | 78 [74, 82] | 74 [70, 78] |
Difference in CR rate, % [95% CI] |
3.9 [-1.9, 9.7] | |
p-value# | 0.1557 |
¶By blinded independent central review, per 2014 Lugano response criteria.
#Cochran-Mantel-Haenszel chi-squared test, with a two-sided significance boundary of 0.01.
NE = Not Estimable; US = United States.
POLIVY Prescribing Information. South San Francisco, CA: Genentech, Inc.; April 2023.
POLIVY Prescribing Information. South San Francisco, CA: Genentech, Inc.; April 2023.
Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for B-Cell Lymphomas V.2.2023. © National Comprehensive Cancer Network, Inc. 2023. All rights reserved. Accessed February 27, 2023. To view the most recent and complete version of the guideline, go online to NCCN.org.
Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for B-Cell Lymphomas V.2.2023. © National Comprehensive Cancer Network, Inc. 2023. All rights reserved. Accessed February 27, 2023. To view the most recent and complete version of the guideline, go online to NCCN.org.
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Data on File. South San Francisco, CA; Genentech, Inc. 2023.
Data on File. South San Francisco, CA; Genentech, Inc. 2023.
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