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Obinutuzumab plus Lenalidomide (GALEN) for the treatment of relapse/refractory aggressive lymphoma: a phase II LYSA study

Abstract : Lenalidomide is a potent immunomodulatory agent that has demonstrated clinical activity in the treatment of both diffuse large B cell lymphomas (DLBCL) and mantle cell lymphomas (MCL). In relapsed/refractory (R/R) DLBCL, two large prospective studies evaluating lenalidomide monotherapy demonstrated an overall response rate (ORR) of 28% (N = 108) and 27.5% (N = 51), respectively [1, 2]. In patients with R/R MCL patients, lenalidomide induced an ORR of 40% (N = 170) [3, 4]. In 2013, the FDA approved lenalidomide for the treatment of R/R MCL. Obinutuzumab is a unique type II glycoengineered monoclonal anti-CD20 antibody (Ab) with increased ADCC and increased direct cell death induction compared to rituximab. In monotherapy, obinutuzumab demonstrated efficacy in patients with MCL and DLBCL [5]. The ORR after treatment with obinutuzumab monotherapy was 28% and 27% in R/R DLBCL and MCL, respectively [5]. Furthermore, the combination of lenalidomide and rituximab (R 2 regimen) demonstrated promising efficacy in patients with follicular lymphoma (FL) [6, 7], MCL [8, 9], and DLBCL [10-13]. We hypothesized that the combination of obinutuzumab (GA) with lenalidomide (LEN) might be even more efficient while retaining a good safety profile. In a phase I B study, we previously identified 20 mg/day as the recommended dose (RD) of lenalidomide in * Franck Morschhauser
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Submitted on : Monday, November 26, 2018 - 9:55:21 AM
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  • HAL Id : inserm-01934613, version 1



Roch Houot, • Guillaume Cartron, • Fontanet Bijou, • Sophie de Guibert, Gilles A. Salles, et al.. Obinutuzumab plus Lenalidomide (GALEN) for the treatment of relapse/refractory aggressive lymphoma: a phase II LYSA study. Leukemia, Nature Publishing Group: Open Access Hybrid Model Option B, 2018. ⟨inserm-01934613⟩



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