CD20 inhibitors(B-lymphocyte antigen CD20 inhibitors), CD3 stimulants(T cell surface glycoprotein CD3 stimulants), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects)

Therapeutic Areas

NeoplasmsImmune System DiseasesHemic and Lymphatic Diseases+ [1]

Active Indication

Diffuse large B-cell lymphoma recurrentDiffuse large B-cell lymphoma refractoryDiffuse Large B-Cell Lymphoma+ [23]

Inactive Indication-

Originator Organization

F. Hoffmann-La Roche Ltd.

Active Organization

Roche Holding AG

Roche China Holding Ltd.

Genentech, Inc.

+ [7]

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

Canada (24 Mar 2023),

Diffuse Large B-Cell LymphomaFollicular LymphomaHigh grade B-cell lymphoma+ [1]

RegulationAccelerated Approval (United States), Orphan Drug (European Union), Priority Review (China), Breakthrough Therapy (China), Conditional marketing approval (China), Orphan Drug (Australia), Conditional marketing approval (European Union), Conditional marketing approval (Canada), Priority Review (United States)

Structure/Sequence

Sequence Code 10044005

Source: *****

Sequence Code 10044025

Source: *****

Sequence Code 616723731

Source: *****

Sequence Code 616723732

Source: *****

Clinical Trials associated with Glofitamab

NCT06922604

/ Not yet recruitingPhase 1IIT

A Phase 1b Study of Glofitamab in CNS Lymphoma

This phase Ib trial tests the safety and side effects of glofitamab after pre-treatment with obinutuzumab and how well they work in treating patients with central nervous system (CNS) lymphoma. Glofitamab is a bispecific antibody that can bind to two different antigens (substances that cause the body to make a specific immune response) at the same time. Glofitamab binds to CD20 on lymphoma cells, and CD3 on T-cells (a type of white blood cell) and may interfere with the ability of cancer cells to grow and spread. Obinutuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Obinutuzumab can also be administered as a pre-treatment to make glofitamab safer and more tolerable. Giving glofitamab with obinutuzumab pre-treatment may be safe, tolerable, and/or effective in treating patients with CNS lymphoma.

Start Date23 Sep 2025

Sponsor / Collaborator

City of Hope National Medical Center

[+1]

NCT06670105

/ Not yet recruitingPhase 2

A Phase 2 Trial of Glofitamab for Minimal Residual Disease in Patients With Large B-cell Lymphoma

The goal of this clinical research study is to learn if glofitamab can help to prevent recurrence of LBCL in patients who have achieved CR after standard first-line therapy but have tested positive for MRD. The safety of glofitamab will also be studied.

Start Date06 Jun 2025

Sponsor / Collaborator

Genentech, Inc.

NCT06570447

/ RecruitingPhase 2IIT

An Open-label, Single-arm, Single-center, Phase II Clinical Trial of Glofitamab Combination With Chidamide in Patients With Recurrent and Refractory Diffuse Large B-Cell Lymphoma

An open-label, single-arm, single-center, phase II clinical trial to evaluate the feasibility, efficacy and safety of Glofitamab Combination with chidamide in patients with recurrent/refractory diffuse large B-cell lymphoma.

Start Date15 May 2025

Sponsor / Collaborator

Tianjin Medical University Cancer Institute and Hospital

100 Clinical Results associated with Glofitamab

100 Translational Medicine associated with Glofitamab

100 Patents (Medical) associated with Glofitamab

Literatures (Medical) associated with Glofitamab

01 Feb 2025·COMPUTERS IN BIOLOGY AND MEDICINE

Structural insight into CD20/CD3-bispecific antibodies by molecular modeling

Article

Author: Chu, Xiaojie ; Hou, Jing-Zhou ; Sun, Ze-Yu ; Feng, Zhiwei ; Xie, Xiang-Qun ; Hou, GanQian ; Liang, Tianjian ; Li, Wei ; Zhang, Yiyang

Non-Hodgkin's Lymphoma (NHL) remains a significant challenge in hematology, with chemotherapy and radiation therapy as conventional treatment options, albeit with limitations such as adverse effects. Immunotherapy, particularly bispecific antibodies (BsAbs) T cell engagers (TCEs), has emerged as a promising approach. Despite their potential, TCEs pose challenges, including adverse events like cytokine release syndrome. Understanding the structural details of TCEs and their interactions with target proteins is crucial for optimizing their therapeutic efficacy and toxicity. In this study, we further developed our protocol MCCS-Docker for protein-protein interactions and applied it to investigate the structural intricacies of CD3 interactions with therapeutic antibodies such as OKT3, UCHT1, Mosunetuzumab, Odronextumab, Glofitamab, and Epcoritamab using computational modeling techniques. Our analysis not only approved the effectiveness of our updated MCCS-Docker protocol but also revealed detailed binding interactions between the BsAbs and CD3, elucidating key residues of Tyrosine and Asparagine in the antibodies involved in the binding interface. Molecular dynamics simulations validated the stability of these interactions over time, confirming the reliability of the binding poses generated from docking studies. Overall, our study offered a novel method to predict critical residues in protein-protein interactions and enhanced the understanding of the structural determinants governing BsAb interactions with target proteins, offering valuable insights for designing and optimizing immunotherapeutic agents for NHL and related hematologic malignancies.

20 Jan 2025·JOURNAL OF CLINICAL ONCOLOGY

Glofitamab in Relapsed/Refractory Mantle Cell Lymphoma: Results From a Phase I/II Study

Article

Author: Trněný, Marek ; Bartlett, Nancy L. ; Carlo-Stella, Carmelo ; Humphrey, Kathryn ; Phillips, Tycel Jovelle ; Carlile, David J. ; Filézac de L'Etang, Audrey ; Morschhauser, Franck ; Wrobel, Tomasz ; Offner, Fritz ; Zaucha, Jan ; Bachy, Emmanuel ; Lundberg, Linda ; Qayum, Naseer ; Dickinson, Michael ; Crump, Michael ; Relf, James ; Byrne, Ben

PURPOSE:

Patients with relapsed/refractory (R/R) mantle cell lymphoma (MCL) have a poor prognosis. The phase I/II NP30179 study (ClinicalTrials.gov identifier: NCT03075696 ) evaluated glofitamab monotherapy in patients with R/R B-cell lymphomas, with obinutuzumab pretreatment (Gpt) to mitigate the risk of cytokine release syndrome (CRS) with glofitamab. We present data for patients with R/R MCL.

METHODS:

Eligible patients with R/R MCL (at least one previous therapy) received Gpt (1,000 or 2,000 mg) 7 days before the first glofitamab dose (single dose or split over 2 days if required). Glofitamab step-up dosing was administered once a day on days 8 (2.5 mg) and 15 (10 mg) of cycle 1, with a target dose of 16 or 30 mg once every 3 weeks from cycle 2 day 1 onward, for 12 cycles. Efficacy end points included investigator-assessed complete response (CR) rate, overall response rate (ORR), and duration of CR.

RESULTS:

Of 61 enrolled patients, 60 were evaluable for safety and efficacy. Patients had received a median of two previous therapies (range, 1-5). CR rate and ORR were 78.3% (95% CI, 65.8 to 87.9) and 85.0% (95% CI, 73.4 to 92.9), respectively. In patients who had received previous treatment with a Bruton tyrosine kinase inhibitor (n = 31), CR rate was 71.0% (95% CI, 52.0 to 85.8) and ORR was 74.2% (95% CI, 55.4 to 88.1). CRS after glofitamab administration occurred in 70.0% of patients, with a lower incidence in the 2,000 mg (63.6% [grade ≥2, 22.7%]) versus 1,000 mg (87.5%; grade ≥2, 62.5%) Gpt cohort. Four adverse events led to glofitamab withdrawal (all infections).

CONCLUSION:

Fixed-duration glofitamab induced high CR rates in heavily pretreated patients with R/R MCL; the safety profile was manageable with appropriate support.

01 Jan 2025·Nature Reviews Clinical Oncology

Benefit with glofitamab plus chemotherapy in transplant-ineligible R/R DLBCL

Article

Author: Romero, Diana

136

News (Medical) associated with Glofitamab

22 hours ago

·pipelinereview.com

European Commission approves Roche’s Columvi as the first bispecific antibody for diffuse large B-cell lymphoma after initial therapy

BASEL, Switzerland I April 14, 2025 I Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Commission has approved Columvi® (glofitamab) in combination with gemcitabine and oxaliplatin (GemOx) for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) not otherwise specified who are ineligible for autologous stem cell transplant (ASCT). With this approval, this Columvi combination is the first bispecific antibody regimen available for people with DLBCL in Europe whose cancer has returned or for those who did not respond to initial treatment. In July 2023, Columvi received a conditional marketing authorisation to treat people with R/R DLBCL after two or more lines of systemic therapy. In addition to today’s approval, a condition to convert the existing marketing authorisation to a regular approval has been fulfilled. “Columvi is the first treatment of its kind to improve survival outcomes for people with DLBCL whose cancer has returned after first-line therapy,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “With this approval, Columvi can now benefit patients even earlier in their treatment, adding to its existing value as an important treatment for DLBCL.” “People with R/R DLBCL not eligible for ASCT represent a challenging population, especially those with primary refractory disease or early relapse whose need for a readily accessible and effective therapy is insufficiently addressed globally,” said Franck Morschhauser, MD, PhD, Professor of Haematology, University Hospital Lille and STARGLO study investigator. “This new Columvi combination is immediately available if a patient’s cancer returns or doesn’t respond to first-line therapy, which is a welcome addition to manage DLBCL.” Approval is based on results from the pivotal phase III STARGLO study, where Columvi in combination with GemOx demonstrated a statistically significant and clinically meaningful overall survival (OS) improvement versus MabThera®/Rituxan® (rituximab) and GemOx (R-GemOx) in people with R/R DLBCL. 1,2 In the primary analysis (conducted after a median follow-up of 11.3 months), there was a 41% reduction in the risk of death in patients treated with Columvi plus GemOx versus R-GemOx (hazard ratio [HR]=0.59, 95% CI: 0.40-0.89, p=0.011). The Columvi combination also met its key secondary endpoints, with a 63% reduction in risk of disease worsening or death (progression-free survival, PFS) compared to R-GemOx (HR=0.37; 95% CI: 0.25–0.55, p<0.0001). 1,2 Follow-up analyses were conducted after all patients had completed therapy (median follow-up of 20.7 months), showing a 25.5 month median OS for people treated with the Columvi combination, nearly double what was seen for people treated with R-GemOx at 12.9 months (HR=0.62, 95% CI: 0.43-0.88). 1,2 Additionally, more than twice as many patients experienced a complete response (58.5% versus 25.3% respectively, with a difference of 33.2% [95% CI: 20.9-45.5]). 1,2 Safety of the combination was consistent with the known safety profiles of the individual medicines. 1,2 DLBCL is an aggressive (fast-growing) type of lymphoma and is one of the most prevalent types of blood cancer among adults. In Europe, an estimated 38,000 people are diagnosed with DLBCL each year. 3,4 Approximately four out of ten DLBCL patients will relapse after first-line treatment and the majority of patients who require subsequent lines of therapy have poor outcomes. 5,6 Whilst second-line treatment advances have been made, challenges with the accessibility of existing medicines and the aggressive nature of DLBCL underscores the urgent need for immediately available treatment options that can control the disease and improve survival. 7 Columvi in combination with GemOx offers an ‘’off-the-shelf’’ treatment regimen, readily available for infusion in any setting, meaning patients can avoid delays in starting their next treatment. Columvi is also designed to be given for a fixed period offering a target end date for people’s course of therapy and the possibility of a treatment-free period after completion. Columvi, along with Lunsumio® (mosunetuzumab), is part of Roche’s industry-leading CD20xCD3 bispecific antibody programme. Together with the clinical development of off-the-shelf allogeneic CAR T-therapies, Roche aims to provide tailored treatment options that suit the diverse needs, preferences, and experiences of people with blood cancers and healthcare systems. About the STARGLO study The STARGLO study [GO41944; NCT04408638 ] is a phase III, multicentre, open-label, randomised study evaluating the efficacy and safety of Columvi® (glofitamab) in combination with gemcitabine plus oxaliplatin (GemOx) versus MabThera®/Rituxan® (rituximab) in combination with GemOx in patients with relapsed or refractory diffuse large B-cell lymphoma who have received at least one prior line of therapy and who are not candidates for autologous stem cell transplant, or who have received two or more prior lines of therapy. Preclinical research indicated an increased antitumour effect when combining Columvi with GemOx over GemOx alone, so the STARGLO study was initiated to further explore the potential complementary effects of the treatment combination. Outcome measures include overall survival (primary endpoint), progression-free survival, complete response rate, objective response rate, duration of objective response (secondary endpoints), and safety and tolerability. About Columvi® (glofitamab) Columvi is a CD20xCD3 T-cell engaging bispecific antibody designed to target CD3 on the surface of T cells and CD20 on the surface of B cells. Columvi was designed with a novel 2:1 structural format. This T-cell engaging bispecific antibody is engineered to have one region that binds to CD3, a protein on T cells, a type of immune cell, and two regions that bind to CD20, a protein on B cells, which can be healthy or malignant. This dual-targeting brings the T cell in close proximity to the B cell, activating the release of cancer cell-killing proteins from the T cell. Columvi is part of Roche’s broad and industry-leading CD20xCD3 T-cell-engaging bispecific antibody clinical development programme that also includes Lunsumio® (mosunetuzumab), which aims to provide tailored treatment options that suit the diverse needs, preferences, and experiences of people with blood cancers and healthcare systems. Roche is investigating Columvi as a monotherapy and in combination with other medicines for the treatment of diffuse large B-cell lymphoma (DLBCL) and mantle cell lymphoma. As part of Roche’s efforts to elevate treatment standards in the earlier stages of DLBCL, where there is the best opportunity to improve long-term outcomes and prevent relapse, Columvi is also being investigated in combination with Polivy® (polatuzumab vedotin) and MabThera®/Rituxan® (rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP) in previously untreated DLBCL in the phase III SKYGLO study [GO44145; NCT06047080 ]. About diffuse large B-cell lymphoma (DLBCL) DLBCL is an aggressive (fast-growing) type of non-Hodgkin lymphoma (NHL) and the most common form, accounting for about one in three cases of NHL. 3 Approximately 160,000 people worldwide are diagnosed with DLBCL each year. 3,8 While it is generally responsive to treatment in the frontline, as many as 40% of people will relapse or have refractory disease, at which time salvage therapy options are limited and survival is short. 5,6 Improving treatments earlier in the course of the disease and providing much needed alternative options could help to improve long-term outcomes. About Roche in haematology Roche has been developing medicines for people with malignant and non-malignant blood diseases for more than 25 years; our experience and knowledge in this therapeutic area runs deep. Today, we are investing more than ever in our effort to bring innovative treatment options to patients across a wide range of haematologic diseases. Our approved medicines include MabThera®/Rituxan® (rituximab), Gazyva®/Gazyvaro® (obinutuzumab), Polivy® (polatuzumab vedotin), Venclexta®/Venclyxto® (venetoclax) in collaboration with AbbVie, Hemlibra® (emicizumab), PiaSky® (crovalimab), Lunsumio® (mosunetuzumab) and Columvi® (glofitamab). Our pipeline of investigational haematology medicines includes T-cell engaging bispecific antibody cevostamab, targeting both FcRH5 and CD3 and Tecentriq® (atezolizumab). Our scientific expertise, combined with the breadth of our portfolio and pipeline, also provides a unique opportunity to develop combination regimens that aim to improve the lives of patients even further. About Roche Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice. For over 125 years, sustainability has been an integral part of Roche’s business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com . All trademarks used or mentioned in this release are protected by law. References [1] Abramson J, et al. Glofitamab plus Gemcitabine and Oxaliplatin (Glofit-GemOx) for Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL): Results of a Global Randomized Phase III trial (STARGLO). Presented at: EHA Hybrid Congress; 2024 Jun 3-16. Abstract #LB3438. [2] Abramson J, et al. Glofitamab plus gemcitabine and oxaliplatin (GemOx) versus rituximab-GemOx for relapsed or refractory diffuse large B-cell lymphoma (STARGLO): a global phase 3, randomised, open-label trial. Lancet 2024; 404 (10466): 1940-1954. [3] UpToDate. Patient education: Diffuse large B cell lymphoma in adults (Beyond the Basics). [Internet; cited 2025 April]. Available from: https://www-uptodate-com.libproxy1.nus.edu.sg/contents/diffuse-large-b-cell-lymphoma-in-adults-beyond-the-basics . [4] World Health Organization. Numbers derived from GLOBOCAN 2022. Europe Factsheet [Internet; cited 2025 April]. Available from: https://gco-iarc-who-int.libproxy1.nus.edu.sg/media/globocan/factsheets/populations/908-europe-fact-sheet.pdf . [5] Maurer MJ, Ghesquières H, Jais JP, et al. Event-free survival at 24 months is a robust end point for disease-related outcome in diffuse large B-cell lymphoma treated with immunochemotherapy. J Clin Oncol. 2014;32(10):1066-1073. [6] Sehn LH, et al. Diffuse Large B-Cell Lymphoma. N Engl J Med. 2021;384(9):842-858. [7] Fabbri N, Mussetti A and Sureda A. Second-line treatment of diffuse large B-cell lymphoma: Evolution of options. Semin Hematol 2023; 60(5): 305–312. [8] World Health Organization. Numbers derived from GLOBOCAN 2022. Non-Hodgkin Lymphoma Factsheet [Internet; cited 2025 April]. Available from: https://gco-iarc-who-int.libproxy1.nus.edu.sg/media/globocan/factsheets/cancers/34-non-hodgkin-lymphoma-fact-sheet.pdf . SOURCE: Roche

Phase 3Clinical ResultDrug ApprovalImmunotherapyCell Therapy

14 Apr 2025

·www.pharmaceutical-technology.com

Roche’s Columvi combo gains EC approval for DLBCL

Roche continues to explore Columvi as both a single agent and with other medicines for the treatment of mantle cell lymphoma and DLBCL. Credit: © 2022 F. Hoffmann-La Roche Ltd – All rights reserved. Roche has secured approval from the European Commission (EC) for Columvi (glofitamab) plus gemcitabine and oxaliplatin (GemOx) combo to treat adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL). This authorisation permits the use of the combo for individuals not eligible for autologous stem cell transplant. The approval of the Columvi combo, the first bispecific antibody regimen for DLBCL in Europe, follows a conditional marketing authorisation granted in July 2023 for R/R DLBCL treatment. The decision also satisfies the requirement to transition the present marketing authorisation to a standard approval. The pivotal Phase III STARGLO trial outcomes underpin the EC approval, demonstrating that Columvi plus GemOx significantly improves overall survival compared to MabThera/Rituxan (rituximab) and GemOx (R-GemOx) in R/R DLBCL patients. Columvi plus GemOx provides an off-the-shelf treatment regimen, providing a readily available option for infusion, which can help avoid delays in starting treatment. Columvi and Lunsumio (mosunetuzumab) are a part of the company’s cluster of differentiation 20 (CD20)xCD3 bispecific antibody programme. Roche Global Product Development head and chief medical officer Levi Garraway stated: “Columvi is the first treatment of its kind to improve survival outcomes for people with DLBCL whose cancer has returned after first-line therapy. “With this approval, Columvi can now benefit patients even earlier in their treatment, adding to its existing value as an important treatment for DLBCL.” Roche’s strategy encompasses the clinical development of allogeneic CAR T-therapies, aiming to offer tailored treatment alternatives for the diverse needs of individuals with blood cancers. Columvi’s design involves a 2:1 structural format, targeting CD3 on T cells and CD20 on B cells. The company continues to explore Columvi as both a single agent and with other medicines for the treatment of mantle cell lymphoma and DLBCL. In the Phase III SKYGLO study, it is also being evaluated with Polivy (polatuzumab vedotin) and MabThera/Rituxan (rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP) for previously untreated DLBCL, to enhance long-term outcomes and relapse prevention. In March 2025, Oxford BioTherapeutics (OBT) entered a multi-year partnership with Roche for antibody-based therapeutics to treat cancer.

ImmunotherapyPhase 3Drug ApprovalBiosimilar

14 Apr 2025

·pmlive.com

Roche’s Columvi granted EC approval to treat diffuse large B-cell lymphoma

Roche’s Columvi (glofitamab) has been approved by the European Commission (EC) as part of a combination treatment for diffuse large B-cell lymphoma (DLBCL). The CD20xCD3 T-cell engaging bispecific antibody has been authorised alongside gemcitabine and oxaliplatin (GemOx) to treat adults with relapsed or refractory DLBCL not otherwise specified who are not candidates for an autologous stem cell transplant. Approximately 38,000 people in Europe are diagnosed annually with DLBCL, an aggressive form of non-Hodgkin lymphoma. Despite DLBCL being generally responsive to treatment in the frontline, as many as 40% of patients will relapse or have refractory disease, at which time salvage therapy options are limited and survival is short. Columvi is given for a fixed period, providing patients with a target end date for their course of treatment as well as the possibility of treatment-free periods. It is also designed to be off-the-shelf, meaning that treatment can begin soon after diagnosis. The drug was granted conditional marketing authorisation by the EC in 2023 to treat patients with relapsed or refractory DLBCL after two or more lines of systemic therapy. Alongside the new approval, a condition to convert the existing marketing authorisation to a regular approval has been fulfilled. The EC’s latest decision was supported by positive results from the phase 3 STARGLO trial, in which Columvi plus GemOx demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) compared to rituximab plus GemOx (R-GemOx). The Columvi combination was associated with a 41% reduction in the risk of death and a 63% reduction in risk of disease worsening or death compared to R-GemOx. Follow-up analyses also showed a 25.5 month median OS for patients treated with the Columvi regimen compared to 12.9 months for the R-GemOx group, and more than twice as many patients receiving Roche’s combination experienced a complete response. The company’s chief medical officer and head of global product development, Levi Garraway, said: “Columvi is the first treatment of its kind to improve survival outcomes for people with DLBCL whose cancer has returned after first-line therapy. “With this approval, Columvi can now benefit patients even earlier in their treatment, adding to its existing value as an important treatment for DLBCL.”

Clinical ResultDrug ApprovalCell TherapyPhase 3Immunotherapy

100 Deals associated with Glofitamab

External Link

KEGG	Wiki	ATC	Drug Bank
D11833	-	-	DB16371

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Diffuse large B-cell lymphoma recurrent	Canada	Hoffmann-La Roche Ltd.	25 Mar 2023
Diffuse large B-cell lymphoma refractory	Canada	Hoffmann-La Roche Ltd.	25 Mar 2023
Diffuse Large B-Cell Lymphoma	Canada	Hoffmann-La Roche Ltd.	24 Mar 2023
Follicular Lymphoma	Canada	Hoffmann-La Roche Ltd.	24 Mar 2023
High grade B-cell lymphoma	Canada	Hoffmann-La Roche Ltd.	24 Mar 2023
Mediastinal large B-cell lymphoma	Canada	Hoffmann-La Roche Ltd.	24 Mar 2023

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Mantle-Cell Lymphoma	Phase 3	South Korea	Roche China Holding Ltd.	09 Oct 2023
Mantle-Cell Lymphoma	Phase 3	South Korea	Genentech, Inc.	09 Oct 2023
Mantle-Cell Lymphoma	Phase 3	South Korea	F. Hoffmann-La Roche Ltd.	09 Oct 2023
CD20 positive Large B-cell lymphoma	Phase 3	United States	Roche Holding AG	18 Sep 2023
CD20 positive Large B-cell lymphoma	Phase 3	China	Roche Holding AG	18 Sep 2023
CD20 positive Large B-cell lymphoma	Phase 3	Japan	Roche Holding AG	18 Sep 2023
CD20 positive Large B-cell lymphoma	Phase 3	Argentina	Roche Holding AG	18 Sep 2023
CD20 positive Large B-cell lymphoma	Phase 3	Australia	Roche Holding AG	18 Sep 2023
CD20 positive Large B-cell lymphoma	Phase 3	Belgium	Roche Holding AG	18 Sep 2023
CD20 positive Large B-cell lymphoma	Phase 3	Brazil	Roche Holding AG	18 Sep 2023

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04970901 (LOTIS-7, PipelineReview) Manual	Phase 1	Diffuse Large B-Cell Lymphoma Second line \| Third line	29	ZYNLONTA + glofitamab (2L+ DLBCL)	aicwerhhlh(vxwpdgcwef) = wxlexvpfhe baydvzunag (uialojbcse ) View more	Positive	11 Dec 2024
NCT04970901 (LOTIS-7, PipelineReview) Manual	Phase 1	Diffuse Large B-Cell Lymphoma Second line \| Third line	29	ZYNLONTA (3L+ DLBCL)	aicwerhhlh(vxwpdgcwef) = babiabxaay baydvzunag (uialojbcse ) View more	Positive	11 Dec 2024
NCT03075696 (ASH2024) Manual	Phase 2	Large B-cell lymphoma Third line	155	Glofitamab	qxjfgwlznm(ebvnawpeyr) = two new Grade ≥3 AEs (neutropenia [Grade 3] and adenocarcinoma pancreas [Grade 4]) were reported. xoszdbtzcl (afplijvhda )	Positive	09 Dec 2024
NCT05364424 (GO43693, ASH2024) Manual	Phase 1	Diffuse Large B-Cell Lymphoma	41	Glofitamab inIfosfamideon CarboplatinEtoposide	yktggicfgp(iodvutrscr) = lthhcqxoqt qwlgaphspx (vjqhgpjbqs, 60.0 - 90.7) View more	Positive	09 Dec 2024
ASH2024	Not Applicable	Refractory High-Grade B-Cell Lymphoma	-	Glofitamab+Polatuzumab Vedotin	ynmbuidzmu(bhddbekyql) = The most common adverse event (AE) was CRS (43%), which was mostly Grade (Gr) 1-2 (Gr 1 27%, Gr 2 15% per ASTCT criteria); one pt had Gr 3 CRS and one had fatal Gr 5 CRS (occurred in the context of unresolved infection; pt declined further CRS management at Gr 3). CRS events were managed with tocilizumab (34%), fluids (23%), low flow oxygen (20%), or corticosteroids (14%) and 3 pts (5.4%) were admitted to intensive care. hbdwwwvxyx (fbujfznlra ) View more	-	09 Dec 2024
ASH2024	Not Applicable	Diffuse Large B-Cell Lymphoma	-	Glofit-GemOx	aghnyvgpqd(shsjclmyqu) = cgrhpdltvb bwpxivaoqx (xirstapxgj ) View more	-	09 Dec 2024
ASH2024	Not Applicable	Diffuse Large B-Cell Lymphoma	-	R-GemOx	aghnyvgpqd(shsjclmyqu) = clwfvzpggh bwpxivaoqx (xirstapxgj ) View more	-	09 Dec 2024
ASH2024	Not Applicable	Diffuse large B-cell lymphoma recurrent	-	Glofitamab Monotherapy	ebmdqovdgd(lrcjkzdynz) = tlmoftamco hftqlezkyh (iplfmgaano ) View more	-	09 Dec 2024
ASH2024	Not Applicable	Diffuse Large B-Cell Lymphoma	-	Glofitamab with Gemcitabine and Oxaliplatin	cwnocvbagi(rcvfbbypnm) = cgayyegviy fsinbqwjsm (lciebcefkf, NA) View more	-	09 Dec 2024
ASH2024	Not Applicable	Diffuse Large B-Cell Lymphoma	-	Rituximab with Gemcitabine and Oxaliplatin	cwnocvbagi(rcvfbbypnm) = azfpixxdbr fsinbqwjsm (lciebcefkf, NA) View more	-	09 Dec 2024
ASH2024	Not Applicable	-	-	Vehicle control	pmtexyutgj(zzepcyedyo) = mnuognstpi pmtakfaohg (umshiorlhy )	-	08 Dec 2024
ASH2024	Not Applicable	Mantle-Cell Lymphoma	-	Glofitamab	evgulzjuou(qdmjiwoaug) = zychkhdiit uaqjnqaeri (rduzhaxnnv ) View more	-	07 Dec 2024
NCT03075696 (NP30179, Pubmed \| J Clin Oncol) Manual	Phase 1/2	Mantle-Cell Lymphoma	60	Glofitamab monotherapy	nedvvtheor(ipmduahvhs) = bhzgoltbvu lpkuuhhaxp (jarkoibckz ) View more	Positive	04 Oct 2024
NCT03075696 (NP30179, Pubmed \| J Clin Oncol) Manual	Phase 1/2	Mantle-Cell Lymphoma	60	Glofitamab monotherapy (previous treatment with a Bruton tyrosine kinase inhibitor)	fuzoldbxnp(aaimddqqwj) = tyoofmxxvc zkcrybitph (mdujptysjt, 52.0 - 85.8) View more	Positive	04 Oct 2024

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Identify the latest clinical trials across global registries.

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Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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Regulation

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Bio Sequences Search & Analysis

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Chemical Structures Search & Analysis