A study of registry data provides reassurance that the performance of standard-of-care therapy in patients with diffuse large B-cell lymphoma (DLBCL) serving as controls in drug trials is in line with real-world results. Prokop Vodicka, of the Charles University and General Hospital, Prague, Czech Republic, and colleagues presented the results at the 65th ASH Annual Meeting and Exposition.
For the study, researchers examined data from the Czech Lymphoma Study Group registry between 2010 and 2021 for 2,612 patients with previously untreated DLBCL or high-grade BCL who were treated with R-CHOP, the traditional standard of care.
They looked at survival outcomes for patients overall and then analyzed outcomes for patients who would meet the stringent inclusion and exclusion criteria for DLBCL studies that featured R-CHOP as a control arm, including the POLARIX study, which supported the US Food and Drug Administration’s April 2023 approval of polatuzumab vedotin, an antibody drug conjugate targeting CD97b.
The researchers observed similar survival rates for the phase III study control arms as for subgroups that met the inclusion/exclusion criteria in their own registry data (see TABLE).
| TABLE. R-CHOP Outcomes, DLBCL Trial Controls Versus Registry Data | |||
| GOYA trial: Obinutuzumab or rituximab plus CHOP vs R-CHOP in previously untreated DLBCL (n=1,414) | |||
| Endpoint | Trial population, R-CHOP | RW registry, patients who meet trial criteria | RW registry overall group |
| PFS at 3 years | 67% | 69% | 71% |
| OS at 3 years | 81% | 77% | 78% |
| POLARIX trial: Double-blind, placebo-controlled study of polatuzumab vedotin with R-CHP vs R-CHOP in 879 patients with previously untreated DLBCL (n=879) | |||
| Endpoint | Trial population, R-CHOP | RW registry, patients who meet trial criteria | RW registry, overall group |
| PFS at 2 years | 70% | 71% | 75% |
| OS at 2 years | 89% | 79% | 81% |
The researchers noted that of the total population treated with R-CHOP, 71% fit the trial criteria of GOYA, 59% fit POLARIX, but only 23% met the criteria of the ongoing frontMIND study of CD19 targeted monoclonal antibody tafasitamab + lenalidomide + R-CHOP versus R-CHOP in newly diagnosed high-intermediate and high-risk DLBCL.
Reference
Vodicka P, Janikova A, Belada D, et al. Do the control cohorts of phase III randomized trials reflect the real-world results of DLBCL patients? Abstract #4485. Presented at the 65th ASH Annual Meeting and Exposition; December 9-12; San Diego, California.
© 2025 Mashup Media, LLC, a Formedics Property. All Rights Reserved.