Safety and efficacy of durvalumab with R-CHOP or R2-CHOP in untreated, high-risk DLBCL: a phase 2, open-label trial

Grzegorz S Nowakowski, Wolfgang Willenbacher, Richard Greil, Thomas S Larsen, Krish Patel, Ulrich Jäger, Robert F Manges, Lorenz Trümper, Hele Everaus, Nagesh Kalakonda, Peter Brown, Judit Meszaros Jørgensen, David Cunningham, Justine Dell'Aringa, Brian Fox, Neus Domper Rubio, Nurgul Kilavuz, Marie-Laure Casadebaig, Oliver Manzke, Javier Munoz

16 Citationer (Scopus)

Abstract

Patients with high-risk diffuse large B-cell lymphoma (DLBCL) have poor outcomes following first-line cyclophosphamide, doxorubicin, vincristine, prednisone, and rituximab (R-CHOP). Evidence shows chemotherapy and immune checkpoint blockade can increase antitumor efficacy. This study investigated durvalumab, a programmed death-ligand 1 inhibitor, combined with R-CHOP or lenalidomide + R-CHOP (R2-CHOP) in newly diagnosed high-risk DLBCL. Patients received durvalumab 1125 mg every 21 days for 2-8 cycles + R-CHOP (non-activated B-cell [ABC] subtype) or R2-CHOP (ABC), then durvalumab consolidation (1500 mg every 28 days). Of 46 patients, 43 received R-CHOP and three R2-CHOP. All patients had the high-risk disease; 14 (30.4%) and eight (17.4%) had double- or triple-hit DLBCL, respectively. Following induction, 20/37 (54.1%) patients receiving durvalumab + R-CHOP achieved complete response (CR), and seven (18.9%) partial response (PR); 25 (67.6% [95% CI 50.2-82.0]) continued to consolidation and were progression-free at 12 months. Among efficacy-evaluable patients with double- or triple-hit DLBCL (n = 12), five achieved CR and five PR. Adverse events were generally consistent with R-CHOP. Correlative analyses did not identify conclusive biomarkers of response. Durvalumab + R-CHOP is feasible in DLBCL with no new safety signals, but the combination provided no greater benefit than R-CHOP.

OriginalsprogEngelsk
TidsskriftInternational Journal of Hematology
Vol/bind115
Udgave nummer2
Sider (fra-til)222-232
Antal sider11
ISSN0925-5710
DOI
StatusUdgivet - feb. 2022

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