Five-Year Outcomes of the POLARIX Study Comparing Pola-R-CHP and R-CHOP in Patients With Diffuse Large B-Cell Lymphoma
Franck Morschhauser, Gilles Salles, Laurie H. Sehn, Alex F. Herrera, Jonathan W. Friedberg, Marek Trněný, Georg Lenz, Jeff P. Sharman, Charles Herbaux, John M. Burke, Matthew J. Matasar, Graham P. Collins, Neha Mehta–Shah, Lucie Obéric, Adrien Chauchet, Wojciech Jurczak, Yuqin Song, Antonio Pinto, Shinya Rai, Koji Izutsu, Richard Greil, Larysa Mykhalska, Juan Bergua, Matthew C. Cheung, Ho‐Jin Shin, Greg Hapgood, Eduardo Munhoz, Pau Abrisqueta, Jyh-Pyng Gau, Yanwen Jiang, Bruce McCall, Saibah Chohan, Matthew Sugidono, Mark Yan, Connie Lee Batlevi, Hervé Tilly, Christopher R. Flowers
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) at the 5-year data cut compared with 0.94 (95% CI, 0.67 to 1.33) at 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.