Five-Year Outcomes of the POLARIX Study Comparing Pola-R-CHP and R-CHOP in Patients With Diffuse Large B-Cell Lymphoma

Author(s): Franck Morschhauser, MD, PhD1; Gilles Salles, MD, PhD2; Laurie H. Sehn, MD, MPH3; Alex F. Herrera, MD4; Jonathan W. Friedberg, MD5; Marek Trněný, MD6; Georg Lenz, MD7; Jeff P. Sharman, MD8; Charles Herbaux, MD, PhD9; John M. Burke, MD10; Matthew Matasar, MD11; Graham P. Collins, MBBS, DPhil12; Neha Mehta-Shah, MD13; Lucie Oberic, MD14; Adrien Chauchet, MD15; Wojciech Jurczak, MD, PhD16; Yuqin Song, MD17; Antonio Pinto, MD18; Shinya Rai, MD, PhD19; Koji Izutsu, MD, PhD20; Richard Greil, MD21; Larysa Mykhalska, MD22; Juan M. Bergua-Burgués, MD, PhD23; Matthew C. Cheung, MD24; Ho-Jin Shin, MD, PhD25; Greg Hapgood, MD, PhD26; Eduardo Munhoz, MD27; Pau Abrisqueta, MD, PhD28; Jyh-Pyng Gau, MD29; Yanwen Jiang, PhD30; Bruce McCall, MD30; Saibah Chohan, MSc31; Matthew Sugidono, PharmD30; Mark Yan, PhD31; Connie Lee Batlevi, MD, PhD30; Hervé Tilly, MD32; Christopher R. Flowers, MD33;
Source: DOI: 10.1200/JCO-25-00925
Original Article
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Another update demonstrated the superiority of polatuzumab vedotin plus R-CHOP (Pola-R-CHOP) over R-CHOP alone, with improved progression-free survival (PFS) (64% vs 59%). Overall survival (OS) was not statistically significant; however, the hazard ratio was 0.85, with greater benefit observed in high-risk patients.

ABSTRACT

In the POLARIX study (ClinicalTrials.gov identifier: NCT03274492), polatuzumab vedotin plus rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola-R-CHP) showed a significant progression-free survival (PFS) benefit versus rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in patients with previously untreated intermediate- or high-risk diffuse large B-cell lymphoma (DLBCL; median follow-up: 28 months). In this 5-year update, sustained PFS benefits favoring Pola-R-CHP were observed. In the global intention-to-treat population (N = 879; median follow-up: 64.1 months), Pola-R-CHP demonstrated a significant PFS benefit over R-CHOP (hazard ratio [HR], 0.77 [95% CI, 0.62 to 0.97]), with 5-year PFS rates of 64.9% (95% CI, 59.8 to 70.0) and 59.1% (95% CI, 53.9 to 64.3), respectively. Although not statistically significant, overall survival analysis showed a HR of 0.85 (95% CI, 0.63 to 1.15) the 5-year data cut compared with 0.94 (95% CI, 0.67 to 1.33) the 2-year data cut. In the expanded population, 46 and 62 patients had lymphoma-related deaths in the Pola-R-CHP and R-CHOP arms, respectively. Exploratory analyses showed favorable 5-year survival rates with Pola-R-CHP in high-risk subgroups, including activated B-cell DLBCL and International Prognostic Index score 3-5. Long-term tolerability was similar between treatment arms. Findings confirm Pola-R-CHP represents a standard of care for frontline treatment of DLBCL.

Author Affiliations

1University of Lille, Lille, France; 2Memorial Sloan Kettering Cancer Center, New York, NY; 3BC Cancer Centre for Lymphoid Cancer and the University of British Columbia, Vancouver, BC, Canada; 4City of Hope, Duarte, CA; 5Wilmot Cancer Institute, University of Rochester, Rochester, NY; 6Charles University, Prague, Czech Republic; 7University Hospital Münster, Department of Medicine A—Haematology and Oncology, Münster, Germany; 8Willamette Valley Cancer Institute and Research Center, Florence, OR; 9University of Montpellier, Montpellier, France; 10Rocky Mountain Cancer Centers/US Oncology, Aurora, CO; 11Rutgers Cancer Institute, New Brunswick, NJ; 12Oxford University Hospitals NHS Foundation Trust, Oxford, UK; 13Division of Medical Oncology, Department of Medicine, Washington University School of Medicine, St Louis, MO; 14Department of Hematology, Cancer University Institute of Toulouse Oncopole, Toulouse, France; 15Department of Hematology, Besançon University Hospital, Besançon, France; 16Maria Skłodowska-Curie National Research Institute of Oncology, Kraków, Poland; 17Peking University Cancer Hospital, Beijing, China; 18Hematology-Oncology and Stem Cell Transplantation Unit, Istituto Nazionale Tumori-IRCCS-Fondazione ‘G. Pascale’, Naples, Italy; 19Department of Hematology and Rheumatology, Kindai University, Faculty of Medicine, Osaka-Sayama City, Japan; 20National Cancer Center Hospital, Tokyo, Japan; 21Medical Department III, Paracelsus Medical University Salzburg, Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials, Cancer Cluster Salzburg, Salzburg, Austria; 22Feofaniya Clinical Hospital, Kyiv, Ukraine; 23Servicio de Hematologia y Hemoterapia, Hospital San Pedro de Alcántara, Cáceres, Spain; 24Odette Cancer Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, ON, Canada; 25Division of Hematology-Oncology, Department of Internal Medicine, Research Institute of Medical Science, Pusan National University Hospital, Pusan National University School of Medicine, Busan, South Korea; 26Princess Alexandra Hospital, University of Queensland, Brisbane, QLD, Australia; 27Hospital Erasto Gaertner, Curitiba, Brazil; 28Department of Hematology, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona, Spain; 29Taipei Veterans General Hospital, Taipei, Taiwan; 30Genentech, Inc, South San Francisco, CA; 31Hoffmann-La Roche Ltd, Mississauga, ON, Canada; 32Centre Henri-Becquerel and University of Rouen, Rouen, France; 33M.D. Anderson Cancer Center, Houston, TX

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