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Polatuzumab vedotin (RG7596): An investigational anti-CD79b antibody-drug conjugate (ADC) 1
Currently Enrolling in Previously Untreated
Diffuse Large B-cell Lymphoma (DLBCL)
A Phase III Clinical Trial of
Polatuzumab Vedotin in DLBCL
Phase III • NCT03274492
A Clinical Study Comparing the Effi cacy and Safety of Polatuzumab Vedotin With Rituximab-Cyclophosphamide,
Doxorubicin, and Prednisone (R-CHP) Versus Rituximab-Cyclophosphamide, Doxorubicin, Vincristine, and
Prednisone (R-CHOP) in Participants With DLBCL
Arm A
A randomized,
double-blind,
placebo-controlled
study
Polatuzumab
vedotin
• Previously untreated
patients with DLBCL
• Age 18–80 years
• IPI 2–5
• ECOG performance
status of 0–2
Polatuzumab vedotin +
R-CHP
(Cycles 1–6)
Rituximab
(Cycles 7–8)
R
Arm B
R-CHOP
(Cycles 1–6)
1:1
N=875
Study Endpoints
Primary Outcome Measure:
PFS, defi ned as the time from randomization to the fi rst
occurrence of disease progression or relapse, or death*
Selected Secondary Outcome Measures:
CR as assessed by FDG-PET through blinded independent
central review at the end of treatment visit
Duration of response, defi ned as the time from the fi rst
occurrence of a documented CR or PR to disease progression*
EFSeff, defi ned as the time from randomization to the fi rst
occurrence of disease progression or relapse, or death from any
cause, or other primary effi cacy reason that leads to initiation of any
non–protocol-specifi ed antilymphoma treatment or residual disease*
Overall survival
EORTC QLQ-C30 treatment-related symptoms score
Safety
Rituximab
(Cycles 7–8)
Selected Eligibility Criteria
Previously untreated participants with CD20-positive DLBCL
LVEF ≥50% on cardiac MUGA scan or cardiac echocardiogram
Availability of archival or freshly collected tumor tissue before
study enrollment, and adequate hematologic function
No prior treatment with cytotoxic drugs ≤5 years of screening
No prior use of any monoclonal antibody ≤3 months of screening
No prior use of any anti-CD20 antibody
No prior use of any therapy for DLBCL, with the exception of
nodal biopsy
*As assessed by the investigator through the use of Lugano Response Criteria for Malignant Lymphoma.
Find out if your patients are eligible for enrollment. For more information:
Visit: www.POLARIXstudy.com
Call: Genentech Trial Information Support Line: 1-888-662-6728 (US only)
Email: [email protected]
ClinicalTrials.gov Identifi er: NCT03274492; Sponsor Study Identifi er: GO39942.
CD20=cluster of differentiation 20; CR=complete response; ECOG=Eastern Cooperative Oncology Group; EFSeff=event-free survival-effi cacy; EORTC QLQ-C30=European Organisation for
Research and Treatment of Cancer Quality of Life-Core 30 Questionnaire; FDG-PET=fl uorodeoxyglucose-positron emission tomography; IPI=international prognostic index; LVEF=left ventricular
ejection fraction; MUGA=multigated acquisition; PFS=progression-free survival; PR=partial response.
Reference: 1. Roche. Product development portfolio. https://www.roche.com/research_and_development/who_we_are_how_we_work/pipeline.htm. Updated July 26, 2018. Accessed September 4, 2018.
This compound and the combination of agents and their uses are investigational and have not been approved by the US Food and Drug Administration. Effi cacy and safety have not been established.
The information presented should not be construed as a recommendation for use. The relevance of fi ndings in preclinical studies to humans is currently being evaluated.
Information is consistent with ClinicalTrials.gov as of September 4, 2018.
© 2018 Genentech USA, Inc. All rights reserved. BIO/091317/0153d Printed in USA.