Polatuzumab Vedotin in Previously Untreated Diffuse Large B-Cell Lymphoma

Hervé Tilly, Franck Morschhauser, Laurie H. Sehn, Jonathan W. Friedberg, Marek Trněný, Jeff P. Sharman, Charles Herbaux, John M. Burke, Matthew Matasar, Shinya Rai, Koji Izutsu, Neha Mehta-Shah, Lucie Oberic, Adrien Chauchet, Wojciech Jurczak, Yuqin Song, Richard Greil, Larysa Mykhalska, Juan M. Bergua-Burgués, Matthew C. CheungAntonio Pinto, Ho Jin Shin, Greg Hapgood, Eduardo Munhoz, Pau Abrisqueta, Jyh Pyng Gau, Jamie Hirata, Yanwen Jiang, Mark Yan, Calvin Lee, Christopher R. Flowers, Gilles Salles

Research output: Contribution to journalArticlepeer-review

266 Scopus citations


BACKGROUND Diffuse large B-cell lymphoma (DLBCL) is typically treated with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP). However, only 60% of patients are cured with R-CHOP. Polatuzumab vedotin is an antibody–drug conjugate targeting CD79b, which is ubiquitously expressed on the surface of malignant B cells. METHODS We conducted a double-blind, placebo-controlled, international phase 3 trial to evaluate a modified regimen of R-CHOP (pola-R-CHP), in which vincristine was replaced with polatuzumab vedotin, as compared with standard R-CHOP, in patients with previously untreated intermediate-risk or high-risk DLBCL. Patients 18 to 80 years of age were randomly assigned in a 1:1 ratio to receive six cycles of either pola-R-CHP or R-CHOP, plus two cycles of rituximab alone. The primary end point was investigator-assessed progression-free survival. Secondary end points included overall survival and safety. RESULTS Overall, 879 patients underwent randomization: 440 were assigned to the polaR-CHP group and 439 to the R-CHOP group. After a median follow-up of 28.2 months, the percentage of patients surviving without progression was significantly higher in the pola-R-CHP group than in the R-CHOP group (76.7% [95% confidence interval (CI), 72.7 to 80.8] vs. 70.2% [95% CI, 65.8 to 74.6] at 2 years; stratified hazard ratio for progression, relapse, or death, 0.73 by Cox regression; 95% CI, 0.57 to 0.95; P=0.02). Overall survival at 2 years did not differ significantly between the groups (88.7% [95% CI, 85.7 to 91.6] in the pola-R-CHP group and 88.6% [95% CI, 85.6 to 91.6] in the R-CHOP group; hazard ratio for death, 0.94; 95% CI, 0.65 to 1.37; P=0.75). The safety profile was similar in the two groups. CONCLUSIONS Among patients with previously untreated intermediate-risk or high-risk DLBCL, the risk of disease progression, relapse, or death was lower among those who received pola-R-CHP than among those who received R-CHOP.

Original languageEnglish
Pages (from-to)351-363
Number of pages13
JournalNew England Journal of Medicine
Issue number4
StatePublished - Jan 27 2022


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