Obinutuzumab combined with lenalidomide for relapsed or refractory follicular B-cell lymphoma (GALEN): a multicentre, single-arm, phase 2 study

Morschhauser, Franck; Gouill, Steven Le; Feugier, Pierre; Bailly, Sarah; Nicolas‐Virelizier, Emmanuelle; Bijou, Fontanet; Salles, Gilles; Tilly, Hervé; Fruchart, Christophe; Eygen, Koen Van; Snauwaert, Sylvia; Bonnet, Christophe; Haı̈oun, Corinne; Thiéblemont, Catherine; Bouabdallah, Réda; Wu, Ka Lung; Canioni, Danielle; Meignin, Véronique; Cartron, Guillaume; Houot, Roch

doi:10.1016/s2352-3026(19)30089-4

Cited by 69 publications

(47 citation statements)

References 31 publications

(40 reference statements)

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“…In the primary analysis at end-of-induction, the CR rate was 72%, with toxicity consistent with the known profiles of the individual drugs. The authors assert that the efficacy seems higher than that achieved with obinutuzumab plus lenalidomide in the GALEN study [ 130 ], but results in a single-arm study should be interpreted with caution considering the caveats entailed when adding an experimental agent to a known effective combination. In the upfront setting, an interim analysis of a phase 1b/2 study of safety and efficacy of induction with obinutuzumab-bendamustine plus atezolizumab followed by maintenance obinutuzumab-atezolizumab in previously untreated patients with FL (20% with a high risk FLIPI score) showed an end-of-induction ORR of 85% and CR rate of 75%, with one treatment-related death [ 131 ].…”

Section: Indolent B Cell Lymphomasmentioning

confidence: 99%

Current Clinical Applications and Future Perspectives of Immune Checkpoint Inhibitors in Non-Hodgkin Lymphoma

Apostolidis

Sayyed

Darweesh

et al. 2020

Journal of Immunology Research

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Cancer cells escape immune recognition by exploiting the programmed cell-death protein 1 (PD-1)/programmed cell-death 1 ligand 1 (PD-L1) immune checkpoint axis. Immune checkpoint inhibitors that target PD-1/PD-L1 unleash the properties of effector T cells that are licensed to kill cancer cells. Immune checkpoint blockade has dramatically changed the treatment landscape of many cancers. Following the cancer paradigm, preliminary results of clinical trials in lymphoma have demonstrated that immune checkpoint inhibitors induce remarkable responses in specific subtypes, most notably classical Hodgkin lymphoma and primary mediastinal B-cell lymphoma, while in other subtypes, the results vary considerably, from promising to disappointing. Lymphomas that respond to immune checkpoint inhibitors tend to exhibit tumor cells that reside in a T-cell-rich immune microenvironment and display constitutive transcriptional upregulation of genes that facilitate innate immune resistance, such as structural variations of the PD-L1 locus, collectively referred to as T-cell-inflamed lymphomas, while those lacking such characteristics are referred to as noninflamed lymphomas. This distinction is not necessarily a sine qua non of response to immune checkpoint inhibitors, but rather a framework to move the field forward with a more rational approach. In this article, we provide insights on our current understanding of the biological mechanisms of immune checkpoint evasion in specific subtypes of B-cell and T-cell non-Hodgkin lymphomas and summarize the clinical experience of using inhibitors that target immune checkpoints in these subtypes. We also discuss the phenomenon of hyperprogression in T-cell lymphomas, related to the use of such inhibitors when T cells themselves are the target cells, and consider future approaches to refine clinical trials with immune checkpoint inhibitors in non-Hodgkin lymphomas.

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Section: Indolent B Cell Lymphomasmentioning

confidence: 99%

Current Clinical Applications and Future Perspectives of Immune Checkpoint Inhibitors in Non-Hodgkin Lymphoma

Apostolidis

Sayyed

Darweesh

et al. 2020

Journal of Immunology Research

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“…Given that the recommended obinutuzumab dose and schedule ensures target saturation, increased efficacy observed with obinutuzumab is considered to be primarily due to mode of action and not the higher absolute dose given. following on from the promising findings with rituximab-lenalidomide in RELEVANCE [148] and AUGMENT [149], high response rates and encouraging PFS results are now being shown in studies of obinutuzumab-lenalidomide in patients with R/R iNHL [150,151,152].…”

Section: Resultsmentioning

confidence: 99%

“…Studies of obinutuzumab-lenalidomide are also now being conducted. The Phase 2 GALEN trial evaluated lenalidomide-obinutuzumab induction followed by 1 year of lenalidomide-obinutuzumab maintenance and 1 year of further obinutuzumab maintenance in 89 patients with R/R FL [150]. The OR rate at EOI was 79% (95% CI 69-87), with 38% CR (95% CI 28-50).…”

Section: Research Directionsmentioning

confidence: 99%

Anti-CD20 treatment for B-cell malignancies: current status and future directions

Klein

Jamois

Nielsen

2020

Expert Opinion on Biological Therapy

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“…16,17 Emerging data from phase 1/2 clinical trials also show promising results with the combination of lenalidomide plus obinutuzumab. [18][19][20] Building on these data, the phase 1b/2 GO29834 clinical trial combined pola with obinutuzumab and lenalidomide (pola-G-len) in patients with relapsed/refractory FL (Table 1). Interim results were presented at the American Society of Hematology 2019 annual meeting (data cut-off August 2019).…”

Section: In Combination With Chemotherapy or Targeted Agents Relapsed/refractory Settingmentioning

confidence: 99%

<p>Profile of Polatuzumab Vedotin in the Treatment of Patients with Relapsed/Refractory Non-Hodgkin Lymphoma: A Brief Report on the Emerging Clinical Data</p>

Sawalha

Maddocks

2020

OTT

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Polatuzumab vedotin is an anti-CD79b antibody conjugated to monomethyl auristatin E that has shown significant clinical activity in follicular and diffuse large B-cell lymphoma (DLBCL) and is currently FDA-approved in combination with bendamustine and rituximab for patients with relapsed/refractory DLBCL. This review article summarizes data from clinical trials of polatuzumab and discusses its current role and future directions in the treatment of patients with B-cell non-Hodgkin lymphoma. Methods: We conducted a literature search in PubMed and Google Scholar from inception to January 2020, using the following terms: polatuzumab and CD79. We also reviewed the package insert and available abstracts and posters presented at national and international meetings.

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Obinutuzumab combined with lenalidomide for relapsed or refractory follicular B-cell lymphoma (GALEN): a multicentre, single-arm, phase 2 study

Abstract: Running head: Obinutuzumab plus lenalidomide for follicular lymphoma Word limit: 3500 (now 3482)

Cited by 69 publications

References 31 publications

Current Clinical Applications and Future Perspectives of Immune Checkpoint Inhibitors in Non-Hodgkin Lymphoma

Current Clinical Applications and Future Perspectives of Immune Checkpoint Inhibitors in Non-Hodgkin Lymphoma

Anti-CD20 treatment for B-cell malignancies: current status and future directions

<p>Profile of Polatuzumab Vedotin in the Treatment of Patients with Relapsed/Refractory Non-Hodgkin Lymphoma: A Brief Report on the Emerging Clinical Data</p>

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