Effects of obinutuzumab injection: A Synthesis of Findings from 9 Studies

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Original Abstract of the Article

Main Research Findings

Obinutuzumab, a type II anti-CD20 monoclonal antibody, has shown enhanced antibody-dependent cell cytotoxicity (ADCC) compared to rituximab and improved clinical activity in treating certain CD20+ malignancies. 9 A phase 1b study evaluated the safety and efficacy of lenalidomide combined with obinutuzumab (GALEN) in patients with relapsed or refractory (R/R) follicular lymphoma (FL) after rituximab-containing therapy. 8 The combination of obinutuzumab and lenalidomide has been found to be well-tolerated and effective in R/R FL patients. 6 A triplet regimen of obinutuzumab, atezolizumab, and lenalidomide (G-atezo-len) demonstrated effectiveness and tolerability in patients with R/R FL. 2 Polatuzumab vedotin, an antibody-drug conjugate targeting the CD79b component of the B-cell receptor, has demonstrated activity as a single agent and in combination with rituximab in relapsed or refractory diffuse large B-cell lymphoma (DLBCL). 7 The combination of polatuzumab vedotin with obinutuzumab demonstrated safety and efficacy in patients with relapsed or refractory non-Hodgkin lymphomas. Glofitamab, a novel, bivalent CD20-targeting T-cell-engaging bispecific antibody, has been shown to induce durable complete remissions in relapsed or refractory B-cell lymphoma. 3 Venetoclax (Ven), an orally administered, potent BCL-2 inhibitor, has demonstrated efficacy in chronic lymphocytic leukemia (CLL) in combination with rituximab (R) or obinutuzumab (G). 5 Glofitamab has shown efficacy in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). 1

Benefits and Risks

Benefits Summary

Obinutuzumab has shown enhanced antibody-dependent cell cytotoxicity (ADCC) compared to rituximab and improved clinical activity in treating certain CD20+ malignancies. 9 The combination of obinutuzumab and lenalidomide has been found to be well-tolerated and effective in R/R FL patients. 8 Polatuzumab vedotin has demonstrated activity as a single agent and in combination with rituximab in relapsed or refractory diffuse large B-cell lymphoma (DLBCL). 7 Glofitamab, a novel, bivalent CD20-targeting T-cell-engaging bispecific antibody, has been shown to induce durable complete remissions in relapsed or refractory B-cell lymphoma. 3 Glofitamab has shown efficacy in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). 1

Risks Summary

The combination of obinutuzumab and lenalidomide was associated with grade 3-5 adverse events in 84% of patients, serious adverse events in 47%, and adverse events leading to discontinuation of any study drug in 29%. 2 The most common adverse events observed in patients receiving obinutuzumab and lenalidomide were constipation (52.6%), neutropenia (47.4%), and asthenia (36.8%). 8 The most frequent grade 3-4 toxicity observed in patients receiving Venetoclax in combination with bendamustine and rituximab or bendamustine and obinutuzumab was neutropenia. 5

Comparison of Studies

Commonalities of Studies

Multiple studies have demonstrated that obinutuzumab exhibits enhanced antibody-dependent cell cytotoxicity (ADCC) compared to rituximab and has improved clinical activity in treating certain CD20+ malignancies. 9 These studies suggest that obinutuzumab-based combination therapies may offer effectiveness and tolerability for patients with relapsed or refractory B-cell lymphomas. 2 8 6 7 5 3 1

Differences in Studies

These studies vary in the specific drugs used in the obinutuzumab-based combination therapies, the targeted diseases, and the study designs. For example, the combination of obinutuzumab and lenalidomide was associated with grade 3-5 adverse events in 84% of patients, serious adverse events in 47%, and adverse events leading to discontinuation of any study drug in 29% in a study of patients with relapsed or refractory follicular lymphoma. 2 In contrast, the most common adverse events observed in patients receiving obinutuzumab and lenalidomide were constipation (52.6%), neutropenia (47.4%), and asthenia (36.8%) in another study. 8 6 7 5 3 1

Consistency and Contradictions in Results

Multiple studies have demonstrated that obinutuzumab exhibits enhanced antibody-dependent cell cytotoxicity (ADCC) compared to rituximab and has improved clinical activity in treating certain CD20+ malignancies. 9 2 8 6 7 5 3 1 These studies suggest that obinutuzumab-based combination therapies may offer effectiveness and tolerability for patients with relapsed or refractory B-cell lymphomas. 2 8 6 7 5 3 1 However, the direct comparison of these results is challenging due to variations in the specific drugs used in the obinutuzumab-based combination therapies, the targeted diseases, and the study designs. 2 8 6 7 5 3 1

Considerations for Real-World Application

These studies suggest that obinutuzumab may offer enhanced efficacy compared to rituximab in treating certain CD20+ malignancies. 9 However, these studies only suggest that obinutuzumab-based combination therapies may offer effectiveness and tolerability for patients with relapsed or refractory B-cell lymphomas, and these therapies may not be effective for all patients. 2 8 6 7 5 3 1 It is crucial to remember that these therapies have the potential for side effects. 2 8 6 7 5 3 1 Therefore, it is crucial to consult with a healthcare professional before starting any obinutuzumab-based combination therapy to understand the benefits and risks associated with the treatment. 2 8 6 7 5 3 1

Limitations of Current Research

Research on the efficacy and safety of obinutuzumab-based combination therapies is still in its early stages. 2 8 6 7 5 3 1 Future research should involve larger-scale studies with more patients to further investigate the long-term efficacy and safety of these therapies. 2 8 6 7 5 3 1

Future Research Directions

Further research is needed to determine the optimal dosage regimens for obinutuzumab-based combination therapies and to identify which patients would benefit most from these treatments. 2 8 6 7 5 3 1 Research is also needed to compare the effectiveness of these therapies against other treatment options. 2 8 6 7 5 3 1

Conclusion

Obinutuzumab-based combination therapies have the potential to offer effectiveness and tolerability for patients with relapsed or refractory B-cell lymphomas. 2 8 6 7 5 3 1 However, it is crucial to remember that these therapies have the potential for side effects. 2 8 6 7 5 3 1 Therefore, it is crucial to consult with a healthcare professional before starting any obinutuzumab-based combination therapy to understand the benefits and risks associated with the treatment. 2 8 6 7 5 3 1

Literature analysis of 9 papers
Positive Content
9
Neutral Content
0
Negative Content
0
Article Type
0
0
0
0
9
1.

Glofitamab for Relapsed or Refractory Diffuse Large B-Cell Lymphoma.

Author: DickinsonMichael J, Carlo-StellaCarmelo, MorschhauserFranck, BachyEmmanuel, CorradiniPaolo, IacoboniGloria, KhanCyrus, WróbelTomasz, OffnerFritz, TrněnýMarek, WuShang-Ju, CartronGuillaume, HertzbergMark, SuredaAnna, Perez-CallejoDavid, LundbergLinda, RelfJames, DixonMark, ClarkEmma, HumphreyKathryn, HutchingsMartin

DLBCL remission
Cytokine release syndrome
Neurologic events

Glofitamab, a bispecific antibody, showed a 39% complete response rate in patients with relapsed or refractory diffuse large B-cell lymphoma who had received at least two prior lines of therapy. The majority of complete responses were ongoing at 12 months. The most common adverse event was cytokine release syndrome, affecting 63% of patients.

Clinical Trial, Phase IIA Phase II trial is a trial that further evaluates the efficacy and safety of a new drug or treatment, whose safety has been confirmed to some extent in a Phase I trial, in a small number of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

2.

Obinutuzumab-atezolizumab-lenalidomide for the treatment of patients with relapsed/refractory follicular lymphoma: final analysis of a Phase Ib/II trial.

Author: MorschhauserFranck, GhoshNilanjan, LossosIzidore S, PalombaM Lia, MehtaAmitkumar, CasasnovasOlivier, StevensDon, KatakamSudhakar, KnappAndrea, NielsenTina, McCordRon, SallesGilles

FL treatment
Hyperphosphatemia
Hypertriglyceridemia
Lymphopenia
Neutropenia
Thrombocytopenia

The triplet regimen obinutuzumab-atezolizumab-lenalidomide showed promising efficacy and tolerability in patients with relapsed/refractory follicular lymphoma, with a complete response rate of 71.9% at the end of induction.

Clinical Trial, Phase IThe first stage of clinical trials in humans. Evaluates the safety, tolerability, and pharmacokinetics of a new drug/treatment.
Clinical Trial, Phase IIA Phase II trial is a trial that further evaluates the efficacy and safety of a new drug or treatment, whose safety has been confirmed to some extent in a Phase I trial, in a small number of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

3.

Glofitamab, a Novel, Bivalent CD20-Targeting T-Cell-Engaging Bispecific Antibody, Induces Durable Complete Remissions in Relapsed or Refractory B-Cell Lymphoma: A Phase I Trial.

Author: HutchingsMartin, MorschhauserFranck, IacoboniGloria, Carlo-StellaCarmelo, OffnerFritz C, SuredaAnna, SallesGilles, Martínez-LopezJoaquín, CrumpMichael, ThomasDenise N, MorcosPeter N, FerliniCristiano, BröskeAnn-Marie E, BelousovAnton, BacacMarina, DimierNatalie, CarlileDavid J, LundbergLinda, Perez-CallejoDavid, UmañaPablo, MooreTom, WeisserMartin, DickinsonMichael J

B-NHL treatment
Toxicity

This phase I study evaluated glofitamab, a T-cell-engaging bispecific antibody, in relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL) patients.

Clinical Trial, Phase IThe first stage of clinical trials in humans. Evaluates the safety, tolerability, and pharmacokinetics of a new drug/treatment.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

4.

Anti-CD20 Disrupts Meningeal B-Cell Aggregates in a Model of Secondary Progressive Multiple Sclerosis.

Author: RoodselaarJay, ZhouYifan, LeppertDavid, HauserAnja E, UrichEduard, AnthonyDaniel C

Suppress relapse activity

This review discusses the use of anti-CD20 therapies for the treatment of multiple sclerosis (MS). The authors argue that type II anti-CD20 antibodies may be more effective than type I antibodies in the brain.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

5.

Venetoclax plus bendamustine-rituximab or bendamustine-obinutuzumab in chronic lymphocytic leukemia: final results of a phase 1b study (GO28440).

Author: StilgenbauerStephan, MorschhauserFranck, WendtnerClemens-Martin, CartronGuillaume, HallekMichael, EichhorstBarbara, KozloffMark F, GieverThomas, LozanskiGerard, JiangYanwen, HuangHuang, PignataroDaniela Soriano, ScharyWilliam, HumphreyKathryn, MobasherMehrdad, SallesGilles

CLL treatment
High response rate
Increased toxicity
Infection
Neutropenia

Adding bendamustine to Venetoclax-containing regimens for chronic lymphocytic leukaemia increased toxicity without apparent efficacy benefit.

Clinical Trial, Phase IThe first stage of clinical trials in humans. Evaluates the safety, tolerability, and pharmacokinetics of a new drug/treatment.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

6.

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

Author: MorschhauserFranck, Le GouillSteven, FeugierPierre, BaillySarah, Nicolas-VirelizierEmmanuelle, BijouFontanet, SallesGilles A, TillyHervé, FruchartChristophe, Van EygenKoen, SnauwaertSylvia, BonnetChristophe, HaiounCorinne, ThieblemontCatherine, BouabdallahReda, WuKa Lung, CanioniDanielle, MeigninVéronique, CartronGuillaume, HouotRoch

Follicular lymphoma treatment

This study investigated the activity and safety of lenalidomide plus obinutuzumab in previously treated patients with relapsed or refractory follicular lymphoma.

Clinical Trial, Phase IIA Phase II trial is a trial that further evaluates the efficacy and safety of a new drug or treatment, whose safety has been confirmed to some extent in a Phase I trial, in a small number of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.

Language : English

7.

Polatuzumab vedotin in combination with immunochemotherapy in patients with previously untreated diffuse large B-cell lymphoma: an open-label, non-randomised, phase 1b-2 study.

Author: TillyHervé, MorschhauserFranck, BartlettNancy L, MehtaAmitkumar, SallesGilles, HaiounCorinne, MunozJavier, ChenAndy I, KolibabaKathryn, LuDan, YanMark, PenuelElicia, HirataJamie, LeeCalvin, SharmanJeff P

Lymphoma treatment

This study evaluated the safety and preliminary activity of polatuzumab vedotin, an antibody-drug conjugate targeting the CD79b component of the B-cell receptor, in combination with rituximab or obinutuzumab and cyclophosphamide, doxorubicin, and prednisone (CHP) in patients with previously untreated diffuse large B-cell lymphoma.

Clinical Trial, Phase IThe first stage of clinical trials in humans. Evaluates the safety, tolerability, and pharmacokinetics of a new drug/treatment.
Clinical Trial, Phase IIA Phase II trial is a trial that further evaluates the efficacy and safety of a new drug or treatment, whose safety has been confirmed to some extent in a Phase I trial, in a small number of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

8.

An open-label phase 1b study of obinutuzumab plus lenalidomide in relapsed/refractory follicular B-cell lymphoma.

Author: MorschhauserFranck, SallesGilles, Le GouillSteven, TillyHerve, ThieblemontCatherine, BouabdallahKrimo, FabianiBettina, MénardCédric, TarteKarin, CartronGuillaume, HouotRoch

Effective for R/R FL
Well tolerated
Neutropenia

Lenalidomide combined with obinutuzumab is a well-tolerated and effective treatment for relapsed or refractory follicular lymphoma (FL) after rituximab-containing therapy. The recommended dose of lenalidomide is 20mg due to a risk of grade 3/4 neutropenia from cycle 2.

Clinical Trial, Phase IThe first stage of clinical trials in humans. Evaluates the safety, tolerability, and pharmacokinetics of a new drug/treatment.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

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