Tazemetostat + Mosunetuzumab for Follicular Lymphoma
Palo Alto (17 mi)Overseen bySamuel Yamshon, M.D.
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Weill Medical College of Cornell University
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?The goal of this study is to learn about the safety and effectiveness of the combination of tazemetostat pills in combination with mosunetuzumab injections for people with follicular lymphoma who haven't received treatment before. The investigators hypothesize that tazemetostat with mosunetuzumab has the potential to increase the efficacy of the product without compromising the safety.
Tazemetostat is a drug that inhibits EZH2, an enzyme known to drive the development of B-cell lymphomas, and inhibiting it appears to have many effects that slow down lymphoma growth and enhance the immune system's ability to fight it. Tazemetostat is FDA-approved in previously treated follicular lymphoma and currently undergoing study in other lymphomas.
Mosunetuzumab is a bispecific antibody therapy that is a therapeutic strategy that uses the immune system to fight lymphoma, called immunotherapy. Bispecific antibodies have two ends: one attaches to T cells in the immune system and the other attaches to lymphoma cells, helping guide our immune system to attack the cancer. Mosunetuzumab has been studied in follicular lymphoma that has previously been treated, with positive results. Mosunetuzumab is approved by the FDA to be given intravenously (directly into a vein) but is not yet approved by the FDA is not yet approved as an injection under the skin, which is how it is given in this study. They have not yet been studied in combination.
Is the drug Mosunetuzumab, Tazemetostat a promising treatment for follicular lymphoma?Yes, Mosunetuzumab and Tazemetostat are promising treatments for follicular lymphoma. Mosunetuzumab has shown high effectiveness, with 80% of patients responding to it and 60% achieving complete response. Tazemetostat is effective, especially for patients with specific genetic mutations, and has been approved for use when other options are not available.611121314
What safety data is available for the treatment of Tazemetostat and Mosunetuzumab in Follicular Lymphoma?The provided research does not contain any safety data for the treatment of Tazemetostat and Mosunetuzumab in Follicular Lymphoma. The studies listed focus on the safety and efficacy of Certolizumab Pegol and Tocilizumab in conditions like rheumatoid arthritis and psoriasis, which are unrelated to the treatment in question.245910
What data supports the idea that Tazemetostat + Mosunetuzumab for Follicular Lymphoma is an effective drug?The available research does not provide any data on the effectiveness of Tazemetostat + Mosunetuzumab for Follicular Lymphoma. The studies mentioned focus on other drugs and conditions, such as rheumatoid arthritis and thrombocytopenia, but do not include information on this specific drug combination for Follicular Lymphoma.13478
Do I have to stop taking my current medications for this trial?The trial protocol does not specify if you need to stop taking your current medications. However, if you have any conditions listed in the exclusion criteria, you may not be eligible to participate.
Eligibility Criteria
This trial is for adults with untreated follicular lymphoma (Grades 1-3a) who can follow the study plan and are willing to use effective birth control. People with a history of certain blood cancers, severe infections like Hepatitis B/C or HIV, significant heart or lung disease, recent major surgery, CNS diseases, pregnancy, organ transplants, allergic reactions to monoclonal antibodies or active autoimmune diseases cannot join.Treatment Details
The trial tests tazemetostat pills combined with mosunetuzumab injections in patients who haven't had prior treatments for follicular lymphoma. Tazemetostat targets an enzyme linked to lymphoma growth while mosunetuzumab directs the immune system against cancer cells. Their combination effectiveness and safety are under evaluation.
1Treatment groups
Experimental Treatment
Group I: Subcutaneous Mosunetuzumab and Oral TazemetostatExperimental Treatment2 Interventions
50 patients will be enrolled and treated with standard dosing of subcutaneous mosunetuzumab, and with oral tazemetostat by mouth twice daily at standard dosing (800 mg twice daily) beginning at the same time as mosunetuzumab initiation.
Mosunetuzumab is already approved in European Union, United States for the following indications:
🇪🇺 Approved in European Union as Lunsumio for:
- Relapsed or refractory follicular lymphoma after two or more lines of systemic therapy
🇺🇸 Approved in United States as Lunsumio for:
- Relapsed or refractory follicular lymphoma after two or more lines of systemic therapy
Find a clinic near you
Research locations nearbySelect from list below to view details:
Weill Cornell Medicine/NewYork-Presbyterian HospitalNew York, NY
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Who is running the clinical trial?
Weill Medical College of Cornell UniversityLead Sponsor
Genentech, Inc.Industry Sponsor
Epizyme, Inc.Industry Sponsor
References
Safety and efficacy of ocrelizumab in patients with rheumatoid arthritis and an inadequate response to at least one tumor necrosis factor inhibitor: results of a forty-eight–week randomized, double-blind, placebo-controlled, parallel-group phase III trial. [2019]To evaluate the safety and efficacy of ocrelizumab plus methotrexate (MTX) or leflunomide (LEF) in patients with active rheumatoid arthritis (RA) and an inadequate response to tumor necrosis factor α inhibitors.
Clinical and radiographic outcomes at 2 years and the effect of tocilizumab discontinuation following sustained remission in the second and third year of the ACT-RAY study. [2022]To assess the efficacy and safety of tocilizumab (TCZ) plus methotrexate/placebo (MTX/PBO) over 2 years and the course of disease activity in patients who discontinued TCZ due to sustained remission.
Effects of Fostamatinib on the Pharmacokinetics of Oral Contraceptive, Warfarin, and the Statins Rosuvastatin and Simvastatin: Results From Phase I Clinical Studies. [2021]Fostamatinib is a spleen tyrosine kinase inhibitor that has been investigated as therapy for rheumatoid arthritis and immune thrombocytopenic purpura. The present studies assessed the potential for pharmacokinetic interaction between fostamatinib and the commonly prescribed medications oral contraceptive (OC), warfarin, and statins (rosuvastatin, simvastatin) in healthy subjects.
Efficacy and safety of methotrexate plus certolizumab pegol or placebo in active rheumatoid arthritis : Meta-analysis of randomized controlled trials. [2019]This study aimed to assess the relative efficacy and safety of certolizumab pegol (CZP) 200 and 400 mg + methotrexate (MTX) compared to placebo + MTX in patients with active rheumatoid arthritis (RA).
Long-Term Maintenance of Certolizumab Pegol Safety and Efficacy, in Combination with Methotrexate and as Monotherapy, in Rheumatoid Arthritis Patients. [2022]The safety and efficacy of certolizumab pegol (CZP) 400 mg every 4 weeks (Q4W) monotherapy (FAST4WARD/NCT00548834) and in combination with methotrexate (MTX) (014/NCT00544154) in active rheumatoid arthritis (RA) has been published previously. This report outlines final long-term outcomes from the open-label extension (OLE) study (015/NCT00160693), which enrolled patients from these randomized controlled trials (RCTs).
Positive Results for Tazemetostat in Follicular Lymphoma. [2019]A recently reported clinical trial indicates that the EZH2 inhibitor tazemetostat is effective against relapsed or refractory follicular lymphoma. Three of 28 patients with EZH2 mutations had complete responses, and 17 had partial responses.
Pharmaceutical Approval Update. [2020]Fostamatinib (Tavalisse) for thrombocytopenia in adults with chronic immune thrombocytopenia; coagulation factor Xa (recombinant), inactivated-zhzo (Andexxa) for the reversal of anticoagulation; epoetin alfa-epbx (Retacrit), a biosimilar for the treatment of anemia.
Efficacy and safety of add-on tacrolimus versus leflunomide in rheumatoid arthritis patients with inadequate response to methotrexate. [2020]To investigate the efficacy and safety of tacrolimus (TAC) versus leflunomide (LEF) when combined with methotrexate (MTX) in rheumatoid arthritis (RA) patients.
Certolizumab pegol for the treatment of psoriatic arthritis and plaque psoriasis. [2021]Introduction: Certolizumab pegol (CZP) is an Fc-free PEGylated TNF-α inhibitor approved for the treatment of psoriatic arthritis (PsA) and plaque psoriasis in many countries. It demonstrated favorable results in PsA in terms of improvement in peripheral arthritis, dactylitis, and enthesitis in a phase III trial (RAPID-PSA) and in real-life experiences. Recently, three phase III randomized clinical trials (CIMPASI-1, CIMPASI-2, CIMPACT) showed significant and sustained improvements in signs and symptoms of moderate-to-severe plaque psoriasis as well as in quality of life parameters as compared to placebo and etanercept.Areas covered: We reviewed the structure and the mechanism of action of CZP, and critically analyzed data from clinical trials and real-life, concerning its efficacy and safety in all aspects of the psoriatic disease. We designed a comprehensive literature search on this topic, by a review of published articles in indexed international journals up until 31 July 2019.Expertopinion: CZP demonstrated positive results in several domains of psoriatic disease, also in patients previously exposed to other TNF-α inhibitors and in patients receiving re-treatment after treatment interruption. The peculiar chemical structure, along with its well-established efficacy and safety, support CZP as the drug of choice in specific subgroups of patients with psoriatic disease, in particular patients with comorbidities and pregnant or breastfeeding female patients.
Certolizumab Pegol for the Treatment of Moderate to Severe Plaque Psoriasis: 16-Week Results from a Phase 2/3 Japanese Study. [2022]Certolizumab pegol (CZP), the Fc-free, PEGylated anti-tumor necrosis factor, is approved for the treatment of moderate to severe plaque psoriasis (PSO) in Western countries and in Japan, among other indications.
The role of tazemetostat in relapsed/refractory follicular lymphoma. [2021]Large strides have been made in the treatment of follicular lymphoma (FL) over the last few years. Although the majority of patients respond to upfront therapy, many experience disease progression with a progressive shortening of subsequent treatment free intervals. New treatment options are therefore crucial for such patients. Tazemetostat is a first-in-class, selective, oral inhibitor of enhancer of zester homolog 2 (EZH2), a histone methyltransferase that is mutated in about a quarter of FL cases. Tazemetostat was recently approved for the treatment of patients with relapsed FL after 2 or more prior lines of therapy in the presence of an EZH2 mutation and for those without any other available therapeutic option, independently of EZH2 mutation status. In this review, we will summarize the background and key data that led to the development of tazemetostat, and, ultimately, to its approval for this indication.
Safety and efficacy of mosunetuzumab, a bispecific antibody, in patients with relapsed or refractory follicular lymphoma: a single-arm, multicentre, phase 2 study. [2022]Mosunetuzumab is a CD20 × CD3 T-cell-engaging bispecific monoclonal antibody that redirects T cells to eliminate malignant B cells. In a phase 1 study, mosunetuzumab was well tolerated and active in patients with relapsed or refractory B-cell lymphoma. We, therefore, aimed to evaluate the safety and anti-tumour activity of fixed-duration mosunetuzumab in patients with relapsed or refractory follicular lymphoma who had received two or more previous therapies.
Mosunetuzumab: First Approval. [2022]Mosunetuzumab (Lunsumio®), an anti-CD20/CD3 T-cell engaging bispecific antibody, is being developed by Roche for the treatment of relapsed or refractory follicular lymphoma. Mosunetuzumab was recently conditionally approved in the EU for the treatment of relapsed or refractory follicular lymphoma in adults who have received at least two prior systemic therapies. This article summarizes the milestones in the development of mosunetuzumab leading to this first approval for relapsed or refractory follicular lymphoma.
Mosunetuzumab and lymphoma: latest updates from 2022 ASH annual meeting. [2023]Bispecific antibodies are emerging as a promising new immunotherapy modality and are actively being evaluated in clinical trials for patients with lymphoma. As the first BsAb to receive regulatory approval for lymphoma, mosunetuzumab, an antiCD20/anti-CD3 BsAb, is an exciting new option for patients with relapsed or refractory (R/R) follicular lymphoma. The approval was based on results from an international, multicenter, phase 2 trial in patients with relapsed or refractory (R/R) follicular lymphoma following at least 2 prior lines of systemic therapy. Mosunetuzumab demonstrated remarkable efficacy with an overall response rate of 80% and complete response rate of 60%. Here we provided an overview of the latest clinical data on mosunetuzumab in lymphoma presented at the 2022 ASH Annual Meeting.