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DRUG:

Columvi (glofitamab-gxbm)

i
Other names: RG6026, RO7082859, CD20 TCB, RG 6026, RO-7082859, RO 7082859, anti-CD20 CD3 TCB, RG-6026
Company:
Biogen, Roche
Drug class:
CD20 inhibitor, CD3 agonist
Related drugs:
3d
NCI-2024-00054: Glofitamab with Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma (clinicaltrials.gov)
P2, N=30, Suspended, C. Babis Andreadis | N=50 --> 30 | Recruiting --> Suspended
Enrollment change • Trial suspension
|
clonoSEQ
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Gazyva (obinutuzumab) • Jaypirca (pirtobrutinib) • Columvi (glofitamab-gxbm)
4d
Enrollment open • Combination therapy
|
gemcitabine • Gazyva (obinutuzumab) • oxaliplatin • Actemra IV (tocilizumab) • Columvi (glofitamab-gxbm)
9d
Lineage Switch from Therapy-Related B Cell Acute Lymphoblastic Leukemia to Pure Erythroid Leukemia Following CD20-Directed Immunotherapy: A Mechanism for Immune Escape? (AMP 2024)
Six weeks later, while receiving the CD20-directed immunotherapies glofitamab and obinutuzumab, another bone marrow biopsy revealed eradication of the B-ALL and new involvement by pure erythroid leukemia (PEL). This patient's B-ALL lacked an IGH::BCL2 fusion resulting from t(14; 18), suggesting it did not arise through transformation of his prior FL/DLBCL. Instead, the B-ALL was likely caused by his extensive exposure to genotoxic chemotherapy drugs – including alkylating agents – for his preceding lymphomas. The shared cytogenetic and molecular features between this patient's B-ALL and PEL imply they are clonally related.
IO biomarker
|
TP53 (Tumor protein P53) • BCL2 (B-cell CLL/lymphoma 2) • CD20 (Membrane Spanning 4-Domains A1) • KMT2A (Lysine Methyltransferase 2A)
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TP53 mutation • KMT2A rearrangement • MLL rearrangement • BCL2 fusion
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TruSight Myeloid Sequencing Panel
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Gazyva (obinutuzumab) • Columvi (glofitamab-gxbm)
10d
ASCT DLBCL: Glofitamab Bridging ASCT for Patients With Relapsed or Refractory DLBCL (clinicaltrials.gov)
P2, N=40, Recruiting, The First Affiliated Hospital of Soochow University
New P2 trial
|
cytarabine • Columvi (glofitamab-gxbm)
14d
R-Pola-Glo: Rituximab in Combination with Glofitamab and Polatuzumab Vedotin in Patients with Previously Untreated Aggressive B-cell Lymphoma Ineligible for R-CHOP (clinicaltrials.gov)
P2, N=125, Recruiting, Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest | Active, not recruiting --> Recruiting | N=80 --> 125 | Trial primary completion date: Sep 2027 --> Apr 2025
Enrollment open • Enrollment change • Trial primary completion date • Combination therapy
|
Rituxan (rituximab) • Gazyva (obinutuzumab) • Polivy (polatuzumab vedotin-piiq) • Columvi (glofitamab-gxbm)
16d
Glofitamab Induces High Response Rates and Durable Remissions in Patients (Pts) with Heavily Pretreated Relapsed/Refractory (R/R) Mantle Cell Lymphoma (MCL), Including Those with a Poor Prognosis: Subgroup Results from a Phase I/II Study (ASH 2024)
All pts received obinutuzumab pretreatment (1000mg or 2000mg) on Cycle (C) 1 Day (D) 1. Glofitamab induces high response rates in pts with heavily pretreated R/R MCL, including those who have clinical and/or histological features associated with poor prognosis. Clinical and molecular remissions are achieved early in the course of treatment, with durable responses lasting beyond the length of the treatment.
Clinical • P1/2 data
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TP53 (Tumor protein P53)
|
TP53 expression
|
clonoSEQ
|
Gazyva (obinutuzumab) • Columvi (glofitamab-gxbm)
21d
New P2 trial
|
Columvi (glofitamab-gxbm)
23d
G-Pola-ZLP in Diffuse Large B-Cell Lymphoma (clinicaltrials.gov)
P2, N=80, Not yet recruiting, Navy General Hospital, Beijing
New P2 trial
|
lenalidomide • Brukinsa (zanubrutinib) • prednisone • Polivy (polatuzumab vedotin-piiq) • Columvi (glofitamab-gxbm)
29d
New P2 trial
|
bortezomib • Gazyva (obinutuzumab) • Yinuokai (orelabrutinib) • Columvi (glofitamab-gxbm)
1m
New P2 trial
|
lenalidomide • Columvi (glofitamab-gxbm)
1m
GLOASIS: A Phase II Study Evaluating Glofitamab in Combination With Venetoclax Plus Zanubrutinib or Venetoclax Alone in Subjects With Untreated or Relapsed/Refractory High-risk Mantle-cell Lymphoma (clinicaltrials.gov)
P2, N=100, Not yet recruiting, The Lymphoma Academic Research Organisation | Trial completion date: Dec 2031 --> Mar 2032 | Initiation date: Sep 2024 --> Dec 2024 | Trial primary completion date: Feb 2028 --> May 2028
Trial completion date • Trial initiation date • Trial primary completion date • Combination therapy
|
Venclexta (venetoclax) • Gazyva (obinutuzumab) • Brukinsa (zanubrutinib) • Columvi (glofitamab-gxbm)
1m
The landscape of T-cell engagers for the treatment of follicular lymphoma. (PubMed, Oncoimmunology)
CD3 × CD20 BsAbs have shown the most promise in clinical development for B-NHL patients, with structural variations affecting their target affinity and potency. This review summarizes the current clinical trials of BsAbs for relapsed/refractory FL, highlighting the approval of some agents, their role in first-line treatment or combination therapies, their toxicity profiles, and the future of this therapeutic approach compared to other immune cell therapies.
Review • Journal
|
CD20 (Membrane Spanning 4-Domains A1)
|
Epkinly (epcoritamab-bysp) • Lunsumio (mosunetuzumab-axgb) • Columvi (glofitamab-gxbm) • Ordspono (odronextamab)
2ms
Recent advances in the treatment of DLBCL (PubMed, Rinsho Ketsueki)
Treatment with polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin, and prednisone has become the standard of care for newly diagnosed CD20-positive DLBCL with an International Prognostic Index score of 2 to 5, based on its reported efficacy for this indication. In addition, the development of immunotherapy such as anti-CD19-chimeric antigen receptor (CAR)-T therapy and bispecific antibodies such as epcoritamab, mosunetuzumab, and glofitamab has led to a paradigm shift in treatment of relapsed/refractory DLBCL. This review summarizes the evolution of treatment development for DLBCL, as well as the results of the current clinical standard of care and new therapies that are expected to become the standard of care.
Review • Journal
|
CD20 (Membrane Spanning 4-Domains A1)
|
CD20 positive
|
Rituxan (rituximab) • doxorubicin hydrochloride • cyclophosphamide • prednisone • Epkinly (epcoritamab-bysp) • Polivy (polatuzumab vedotin-piiq) • Lunsumio (mosunetuzumab-axgb) • Columvi (glofitamab-gxbm)
2ms
New P1 trial • Combination therapy
|
gemcitabine • Gazyva (obinutuzumab) • oxaliplatin • Actemra IV (tocilizumab) • Columvi (glofitamab-gxbm)
2ms
CO43805: A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Mosunetuzumab or Glofitamab in Combination With CC-220 and CC-99282 in Participants With B-Cell Non-Hodgkin Lymphoma (clinicaltrials.gov)
P1, N=121, Recruiting, Hoffmann-La Roche | Trial completion date: Mar 2029 --> Jul 2028 | Trial primary completion date: Mar 2027 --> Jul 2026
Trial completion date • Trial primary completion date • Combination therapy
|
CD20 (Membrane Spanning 4-Domains A1)
|
CD20 expression
|
Gazyva (obinutuzumab) • Actemra IV (tocilizumab) • Lunsumio (mosunetuzumab-axgb) • iberdomide (CC-220) • Columvi (glofitamab-gxbm) • golcadomide (CC-99282)
2ms
Trial completion date • Trial primary completion date • Combination therapy
|
CD20 (Membrane Spanning 4-Domains A1)
|
CD20 expression
|
Gazyva (obinutuzumab) • Actemra IV (tocilizumab) • Lunsumio (mosunetuzumab-axgb) • iberdomide (CC-220) • Columvi (glofitamab-gxbm) • golcadomide (CC-99282)
2ms
GO43693: A Study Evaluating the Efficacy, Safety, and Pharmacokinetics of Glofitamab in Combination With Rituximab Plus Ifosfamide, Carboplatin Etoposide Phosphate in Participants With Relapsed/Refractory Transplant or CAR-T Therapy Eligible Diffuse B-Cell Lymphoma (clinicaltrials.gov)
P1, N=40, Active, not recruiting, Hoffmann-La Roche | Recruiting --> Active, not recruiting | Trial completion date: Dec 2024 --> Dec 2026 | Trial primary completion date: Dec 2024 --> Dec 2026
Enrollment closed • Trial completion date • Trial primary completion date • Combination therapy
|
TNFA (Tumor Necrosis Factor-Alpha)
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carboplatin • Rituxan (rituximab) • Gazyva (obinutuzumab) • ifosfamide • etoposide IV • Actemra IV (tocilizumab) • Columvi (glofitamab-gxbm)
3ms
Glofitamab Combination With Chidamide in Patients With Recurrent/Refractory DLBCL (clinicaltrials.gov)
P2, N=22, Not yet recruiting, Tianjin Medical University Cancer Institute and Hospital
New P2 trial
|
Epidaza (chidamide) • Columvi (glofitamab-gxbm)
3ms
New P2 trial • Combination therapy • CAR T-Cell Therapy
|
Gazyva (obinutuzumab) • Columvi (glofitamab-gxbm)
3ms
Phase classification • Trial completion date • Trial primary completion date • Combination therapy
|
CD20 (Membrane Spanning 4-Domains A1) • CD19 (CD19 Molecule)
|
Gazyva (obinutuzumab) • Actemra IV (tocilizumab) • Columvi (glofitamab-gxbm) • englumafusp alfa (RG6076)
3ms
New P2 trial • Combination therapy
|
Venclexta (venetoclax) • Gazyva (obinutuzumab) • Brukinsa (zanubrutinib) • Columvi (glofitamab-gxbm)
3ms
Trial completion date • Trial primary completion date • Combination therapy
|
Gazyva (obinutuzumab) • Columvi (glofitamab-gxbm) • maplirpacept (TTI-622)
3ms
New P2 trial • CAR T-Cell Therapy
|
Columvi (glofitamab-gxbm)
4ms
New P2 trial • Combination therapy
|
MEN1703 • Columvi (glofitamab-gxbm)
4ms
The Evolving Role of Bispecific Antibodies in Diffuse Large B-Cell Lymphoma. (PubMed, J Pers Med)
Rituximab was the first one approved...Polatuzumab, a CD79b-targeting ADC, is approved as first-line treatment in high-risk patients in combination with chemo-immunotherapy...To date, two BsAbs (glofitamab and epcoritamab) are approved as monotherapy in third-line treatment in DLBCL. Combination strategies with chemotherapy, immunotherapy, and ADCs are currently under investigation with encouraging results in first-line or subsequent lines of treatment. In the following review, we focus on the structure of BsAbs, the mechanism of action, clinical efficacy, and the mechanisms of resistance to BsAbs.
Review • Journal
|
CD79B (CD79b Molecule)
|
Rituxan (rituximab) • Epkinly (epcoritamab-bysp) • Polivy (polatuzumab vedotin-piiq) • Columvi (glofitamab-gxbm) • Ordspono (odronextamab)
4ms
R-Pola-Glo: Rituximab in Combination With Glofitamab and Polatuzumab Vedotin in Patients With Previously Untreated Aggressive B-cell Lymphoma Ineligible for R-CHOP (clinicaltrials.gov)
P2, N=80, Active, not recruiting, Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest | Recruiting --> Active, not recruiting
Enrollment closed • Combination therapy
|
Rituxan (rituximab) • Gazyva (obinutuzumab) • Polivy (polatuzumab vedotin-piiq) • Columvi (glofitamab-gxbm)
4ms
BP43131: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of RO7443904 in Combination With Glofitamab in Participants With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (clinicaltrials.gov)
P1, N=53, Terminated, Hoffmann-La Roche | N=200 --> 53 | Trial completion date: Apr 2025 --> Jul 2024 | Recruiting --> Terminated | Trial primary completion date: Apr 2025 --> Jul 2024; The study was terminated due to sponsor portfolio re-alignment.
Enrollment change • Trial completion date • Trial termination • Trial primary completion date • Combination therapy
|
CD20 (Membrane Spanning 4-Domains A1) • CD19 (CD19 Molecule)
|
Gazyva (obinutuzumab) • Actemra IV (tocilizumab) • Columvi (glofitamab-gxbm) • RG6333
4ms
PORTAL: A Trial of Polatuzumab Vedotin, Obinutuzumab and Glofitamab as a Peri-CAR-T Cell Treatment Strategy in Large B-cell Lymphoma (clinicaltrials.gov)
P2, N=99, Recruiting, University College, London | Not yet recruiting --> Recruiting | Initiation date: Apr 2024 --> Jul 2024 | Trial primary completion date: Jan 2027 --> Jul 2027
Enrollment open • Trial initiation date • Trial primary completion date • CAR T-Cell Therapy
|
MYC (V-myc avian myelocytomatosis viral oncogene homolog) • BCL2 (B-cell CLL/lymphoma 2) • CD20 (Membrane Spanning 4-Domains A1) • BCL6 (B-cell CLL/lymphoma 6)
|
Gazyva (obinutuzumab) • Polivy (polatuzumab vedotin-piiq) • Columvi (glofitamab-gxbm)
4ms
New trial • Combination therapy • Real-world evidence • Real-world
|
Columvi (glofitamab-gxbm)
5ms
Trial initiation date
|
CD20 (Membrane Spanning 4-Domains A1)
|
Gazyva (obinutuzumab) • Calquence (acalabrutinib) • Columvi (glofitamab-gxbm)
5ms
Glofitamab in Chinese Patients With R/R DLBCL (clinicaltrials.gov)
P=N/A, N=20, Recruiting, Peking Union Medical College Hospital
New trial
|
Columvi (glofitamab-gxbm)
5ms
NCI-2024-00054: Glofitamab With Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma (clinicaltrials.gov)
P2; Not yet recruiting --> Recruiting | Trial completion date: Mar 2028 --> Jul 2028 | Trial primary completion date: Mar 2028 --> Jul 2028
Trial completion date • Trial primary completion date • Enrollment open
|
clonoSEQ
|
Gazyva (obinutuzumab) • Jaypirca (pirtobrutinib) • Columvi (glofitamab-gxbm)
6ms
Enrollment closed • Combination therapy • Circulating tumor DNA
|
MYC (V-myc avian myelocytomatosis viral oncogene homolog) • BCL2 (B-cell CLL/lymphoma 2) • CD20 (Membrane Spanning 4-Domains A1) • BCL6 (B-cell CLL/lymphoma 6)
|
Rituxan (rituximab) • doxorubicin hydrochloride • cyclophosphamide • vincristine • prednisone • Actemra IV (tocilizumab) • Columvi (glofitamab-gxbm)
6ms
Trial completion date • Trial primary completion date • Combination therapy
|
Gazyva (obinutuzumab) • Columvi (glofitamab-gxbm) • maplirpacept (TTI-622)
6ms
Relapse after glofitamab, a novel unmet medical need with high rates of CD20 loss. (PubMed, Br J Haematol)
Br J Haematol 2024 (Online ahead of print). http://doi.org/10.1111/bjh.19455.
Journal
|
CD20 (Membrane Spanning 4-Domains A1)
|
Columvi (glofitamab-gxbm)
7ms
Relapse after glofitamab has a poor prognosis and rates of CD20 loss are high. (PubMed, Br J Haematol)
In a field where CD20 × CD3 bispecific antibodies are entering routine clinical use, our experience highlights a potential means of resistance. It illustrates both the need to further characterise mechanisms of CD20 loss, and to pursue clinical trials of novel non-CD20-directed treatments in this cohort.
Journal
|
CD20 (Membrane Spanning 4-Domains A1)
|
Columvi (glofitamab-gxbm)
7ms
Enrollment open
|
Gazyva (obinutuzumab) • Yescarta (axicabtagene ciloleucel) • Tecartus (brexucabtagene autoleucel) • Columvi (glofitamab-gxbm)
7ms
Disrupting B and T cell Collaboration in Autoimmune Disease: T cell engagers versus CAR T cell therapy? (PubMed, Clin Exp Immunol)
Historically, B and T cell (B-T cell) co-interaction was targeted through different pathways such as alemtuzumab, abatacept, and dapirolizumab with variable impact on B cell depletion (BCD), whereas the majority of patients with AID including rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis and organ transplantation benefit from targeted BCD with anti-CD20 monoclonal antibodies such as rituximab, ocrelizumab or ofatumumab...In the treatment of cancer, chimeric antigen receptor (CAR) T cell therapy and T cell engagers (TCE) that recruit T cells to induce B cell cytotoxicity have delivered promising results for anti-CD19 CAR T cell therapies, the CD19 TCE blinatumomab and CD20 TCE such as mosunetuzumab, glofitamab or epcoritamab. Limited evidence suggests that anti-CD19 CAR T cell therapy may be effective in managing refractory AID whereas we await evaluation of TCE for use in non-oncological indications. Therefore, here, we discuss the potential mechanistic advantages of novel therapies that rely on T cells as effector cells to disrupt B-T cell collaboration toward overcoming rituximab-resistant AID.
Journal • CAR T-Cell Therapy
|
CD19 (CD19 Molecule) • CD27 (CD27 Molecule)
|
CD19 expression
|
Rituxan (rituximab) • Blincyto (blinatumomab) • Epkinly (epcoritamab-bysp) • Lunsumio (mosunetuzumab-axgb) • Columvi (glofitamab-gxbm) • Ocrevus (ocrelizumab)
7ms
Enrollment open • Combination therapy
|
Rituxan (rituximab) • doxorubicin hydrochloride • Gazyva (obinutuzumab) • cyclophosphamide • vincristine • prednisone • Columvi (glofitamab-gxbm)
7ms
Acalabrutinib, Obinutuzumab, and Glofitamab for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma (clinicaltrials.gov)
P2, N=40, Recruiting, City of Hope Medical Center | Not yet recruiting --> Recruiting
Enrollment open
|
CD20 (Membrane Spanning 4-Domains A1)
|
CD20 positive
|
Gazyva (obinutuzumab) • Calquence (acalabrutinib) • Columvi (glofitamab-gxbm)
8ms
New P1/2 trial
|
Imbruvica (ibrutinib) • Gazyva (obinutuzumab) • Columvi (glofitamab-gxbm)