Polatuzumab vedotin plus bendamustine and rituximab in relapsed/ refractory DLBCL: survival update and new extension cohort data

• Type of Material: Article
• Authors: Laurie H Sehn, BC Cancer Centre for Lymphoid Cancer; Mark Hertzberg, Prince of Wales Hospital; Stephen Opat, Monash Health and Monash University; Alex F Herrera, City of Hope Medical Centre; Sarit Assouline, Jewish General Hospital; Christopher Flowers, Emory University; Tae Min Kim, Seoul National University Hospital; Andrew McMillan, Nottingham University Hospital NHS Trust; Muhit Ozcan, Ankara University; Violaine Safar, Centre Hospitalier Lyon-Sud; Gilles Salles, Centre Hospitalier Lyon-Sud; Grace Ku, Genentech Inc; Jamie Hirata, Genentech Inc; Yi Meng Chang, F. Hoffmann–La Roche Ltd.; Lisa Musick, Genentech Inc; Matthew J Matasar, Mem Sloan Kettering Cancer Center
• Language: English
• Date: 2022-01-25
• Publisher: ELSEVIER
• Publication Version: Final Published Version
• Copyright Statement: © 2022 by The American Society of Hematology.
• License: Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International
• Final Published Version (URL): http://dx.doi.org/10.1182/bloodadvances.2021005794
• Title of Journal or Parent Work: BLOOD ADVANCES
• Volume: 6
• Issue: 2
• Start Page: 533
• End Page: 543
• Grant/Funding Information: The study was designed with input from investigators and was sponsored by Genentech, Inc. and F. Hoffmann–La Roche Ltd.
• Keywords: MULTICENTER; CELL; Science & Technology; NON-HODGKINS-LYMPHOMA; Hematology; Life Sciences & Biomedicine; BINDING
• Research Categories: Health Sciences, Oncology

Abstract

Polatuzumab vedotin plus bendamustine and rituximab (pola 1 BR) received regulatory approvals for relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) based on primary results from the randomized arms of the GO29365 study. After the randomized phase, 106 additional patients received pola 1 BR in a single-arm extension cohort. We report updated results from the randomized arms and results of the extension cohort. In this phase 1b/2 study, patients with R/R DLBCL who were transplant ineligible received up to six 21-day cycles of pola 1 BR or BR. The primary end point of the randomized arms was the complete response (CR) rate at end of treatment. Primary objectives of the extension cohort were safety, pharmacokinetic profile, and efficacy of pola 1 BR. As of 7 July 2020, a total of 192 patients with R/R DLBCL were enrolled in the pola 1 BR cohort (n=152 [safety run-in, n=6; randomized, n=40; extension cohort, n=106]) or the BR cohort (n=40). Significant survival benefit with pola 1 BR vs BR persisted in the randomized arms (median progression-free survival, 9.2 vs 3.7 months [hazard ratio, 0.39; 95% confidence interval, 0.23-0.66]; median overall survival, 12.4 vs 4.7 months [hazard ratio, 0.42; 95% confidence interval, 0.24-0.72]). In the extension cohort, the independent review committee-assessed objective response rate was 41.5%, and the CR rate was 38.7%; median independent review committee-assessed progression-free survival and overall survival were 6.6 months and 12.5 months, respectively. No new safety signals with pola 1 BR were identified. Pola 1 BR is an effective treatment option for patients with R/R DLBCL, with a well-characterized and manageable safety profile. This trial was registered at www.clinicaltrials.gov as #NCT02257567.