RE-MIND: Comparing Tafasitamab + Lenalidomide (L-MIND) with a real-world lenalidomide monotherapy cohort in relapsed or refractory diffuse large B-cell lymphoma
| Autor: | Sumeet Ambarkhane, Mark Winderlich, Claudia Castellino, Sascha Tillmanns, Nathan Fowler, Erika Meli, Anna Maria Barbui, Nuwan C. Kurukulasuriya, Gilles Salles, Grzegorz S. Nowakowski, Maurizio Frezzato, Günter Fingerle-Rowson, Thomas D. Rodgers, Bruce Feinberg, Debarshi Dey, Pier Luigi Zinzani, Stephan Parche, Dario Marino |
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| Přispěvatelé: | Zinzani P.L., Rodgers T., Marino D., Frezzato M., Barbui A.M., Castellino C., Meli E., Fowler N.H., Salles G., Feinberg B., Kurukulasuriya N.C., Tillmanns S., Parche S., Dey D., Fingerle-Rowson G., Ambarkhane S., Winderlich M., Nowakowski G.S. |
| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
Oncology
Cancer Research medicine.medical_specialty Combination therapy Antibodies Monoclonal Humanized Retrospective Studie Internal medicine Antineoplastic Combined Chemotherapy Protocols Clinical endpoint medicine Humans Refractory Diffuse Large B-Cell Lymphoma Lenalidomide Retrospective Studies Antineoplastic Combined Chemotherapy Protocol business.industry Retrospective cohort study Confidence interval Propensity score matching Cohort Lymphoma Large B-Cell Diffuse business medicine.drug Human |
| 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 |
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