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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.