| Autor: |
Grzegorz S. Nowakowski, Mark Winderlich, Sumeet Ambarkhane, Günter Fingerle-Rowson, Debarshi Dey, Stephan Parche, Sascha Tillmanns, Nuwan C. Kurukulasuriya, Bruce Feinberg, Gilles Salles, Nathan H. Fowler, Erika Meli, Claudia Castellino, Anna Maria Barbui, Maurizio Frezzato, Dario Marino, Thomas Rodgers, Pier Luigi Zinzani |
| Rok vydání: |
2023 |
| DOI: |
10.1158/1078-0432.c.6664573.v1 |
| Popis: |
Purpose:Tafasitamab, an Fc-modified, humanized, anti-CD19 monoclonal antibody, in combination with lenalidomide, demonstrated efficacy in transplant-ineligible patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL), in the single-arm, phase II L-MIND study (NCT02399085). RE-MIND, a retrospective observational study, generated a historic control for L-MIND to delineate the contribution of tafasitamab to the efficacy of the combination.Patients and Methods:Data were retrospectively collected from patients with R/R DLBCL treated with lenalidomide monotherapy for comparison with tafasitamab + lenalidomide–treated patients (L-MIND). Key eligibility criteria were aligned with L-MIND. Estimated propensity score–based Nearest Neighbor 1:1 Matching methodology balanced the cohorts for nine prespecified prognostic baseline covariates. The primary endpoint was investigator-assessed best overall response rate (ORR). Secondary endpoints included complete response (CR) rate, progression-free survival (PFS), and overall survival (OS).Results:Data from 490 patients going through lenalidomide monotherapy were collected; 140 qualified for matching with the L-MIND cohort. The primary analysis included 76 patients from each cohort who received a lenalidomide starting dose of 25 mg/day. Cohort baseline covariates were comparable. A significantly better ORR of 67.1% (95% confidence interval, 55.4–77.5) was observed for the combination therapy versus 34.2% (23.7–46.0) for lenalidomide monotherapy [odds ratio, 3.89 (1.90–8.14); P < 0.0001]. Higher CR rates were achieved with combination therapy compared with lenalidomide monotherapy [39.5% (28.4–51.4) vs. 13.2% (6.5–22.9)]. Survival endpoints favored combination therapy. Lenalidomide monotherapy outcomes were similar to previously published data.Conclusions:RE-MIND enabled the estimation of the additional treatment effect achieved by combining tafasitamab with lenalidomide in patients with R/R DLBCL. |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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