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ROSEWOOD: A Phase II Randomized Study of Zanubrutinib Plus Obinutuzumab Versus Obinutuzumab Monotherapy in Patients With Relapsed or Refractory Follicular Lymphoma

PL. Zinzani, J. Mayer, CR. Flowers, F. Bijou, AC. De Oliveira, Y. Song, Q. Zhang, M. Merli, K. Bouabdallah, P. Ganly, H. Zhang, R. Johnson, A. Martín García-Sancho, M. Provencio Pulla, M. Trněný, S. Yuen, H. Tilly, E. Kingsley, G. Tumyan, SE....

. 2023 ; 41 (33) : 5107-5117. [pub] 20230728

Jazyk angličtina Země Spojené státy americké

Typ dokumentu klinické zkoušky, fáze II, časopisecké články, randomizované kontrolované studie

Perzistentní odkaz   https://www.medvik.cz/link/bmc24007894

PURPOSE: The combination of zanubrutinib plus obinutuzumab (ZO) was found to be well tolerated with an early signal of efficacy in a phase Ib study. ROSEWOOD is a phase II, randomized study that assessed the efficacy and safety of ZO versus obinutuzumab in patients with relapsed/refractory (R/R) follicular lymphoma (FL). METHODS: Patients with R/R FL who had received ≥2 lines of therapy, including an anti-CD20 antibody and an alkylating agent, were randomly assigned 2:1 to receive ZO or obinutuzumab (O). The primary end point was overall response rate (ORR) by independent central review (ICR). Secondary end points included duration of response (DOR), progression-free survival (PFS), overall survival, and safety. RESULTS: A total of 217 patients were randomized (ZO, 145; O, 72). Median study follow-up was 20.2 months. The study met its primary end point: ORR by ICR was 69% (ZO) versus 46% (O; P = .001). Complete response rate was 39% (ZO) versus 19% (O); 18-month DOR rate was 69% (ZO) versus 42% (O). Median PFS was 28.0 months (ZO) versus 10.4 months (O; hazard ratio, 0.50 [95% CI, 0.33 to 0.75]; P < .001). The most common adverse events with ZO were thrombocytopenia, neutropenia, diarrhea, and fatigue; incidences of atrial fibrillation and major hemorrhage were 3% and 1%, respectively. CONCLUSION: The combination of ZO met its primary end point of a superior ORR versus O, and demonstrated meaningful activity and a manageable safety profile in patients with R/R FL. ZO had a favorable benefit-risk profile compared with O, and represents a potential combination therapy for patients with R/R FL.

BeiGene Co Ltd Shanghai China

BeiGene Switzerland GmbH Basel Switzerland

BeiGene USA Inc San Mateo CA

Calvary Mater Newcastle Waratah NSW Australia

Comprehensive Cancer Centers of Nevada Las Vegas NV

Concord Repatriation General Hospital University of Sydney Concord NSW Australia

Department of Haematology Christchurch Hospital Christchurch New Zealand

Department of Hematology Hospital Universitario de Salamanca IBSAL CIBERONC Salamanca Spain

Department of Internal Medicine Hematology and Oncology Masaryk University and University Hospital Brno Czech Republic

Department of Lymphoma Myeloma MD Anderson Cancer Center Houston TX

Harbin Medical University Cancer Hospital Harbin China

Hematology University Hospital Ospedale di Circolo e Fondazione Macchi ASST Sette Laghi University of Insubria Varese Italy

Henri Becquerel Center Rouen France

Hôpital Haut Lévêque CHU Bordeaux Pessac France

Hospital Universitario Puerta de Hierro Majadahonda Madrid Spain

Institut Bergonié Bordeaux France

Institut Catala d'Oncologia Hospital Duran 1 Reynals Hospital Barcelana Spain

IRCCS Azienda Ospedaliero Universitaria di Bologna Istituto di Ematologia Seràgnoli and Dipartimento di Scienze Mediche e Chirurgiche Università di Bologna Bologna Italy

Jewish General Hospital McGill University Montreal Canada

N N Blokhin Russian Cancer Research Center Moscow Russia

Peking University Cancer Hospital and Institute Beijing China

St Bartholomew's Hospital Barts Health NHS Trust London United Kingdom

The Leeds Teaching Hospitals NHS Trust St James's University Hospital Leeds United Kingdom

Tianjin Medical University Cancer Institute and Hospital Tianjin China

Vseobecna fakultní nemocnice Praha Nové Město Czech Republic

Citace poskytuje Crossref.org

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