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Mosunetuzumab

Generic Name
Mosunetuzumab
Brand Names
Lunsumio
Drug Type
Biotech
Chemical Formula
-
CAS Number
1905409-39-3
Unique Ingredient Identifier
LDJ89SS0YG
Background

Mosunetuzumab is a humanized anti-CD20/CD3 bispecific antibody. It can recognize and bind two different targets simultaneously, CD20 on cancer B-cells and CD3 on T-cells, allowing it to redirect T-cell cytotoxic activity to cancer cells. The standard of care for patients with B-cell lymphoma includes an anti-CD20 monoclonal antibody, such as rituximab, in combination with chemotherapy. However, patients with certain types of B-cell lymphoma, such as follicular lymphoma (FL), chronic lymphocytic leukemia (CLL) or aggressive B-cell lymphoma, have a high probability of relapse or recurrence after treatment. Mosunetuzumab has the potential to circumvent resistance to rituximab in patients with follicular lymphoma, and unlike CAR-T therapies such as axicabtagene ciloleucel and tisagenlecleucel, it is an “off-the-shelf” alternative, readily available to patients. In June 2022, the European Medicines Agency approved mosunetuzumab for the treatment of adult patients with relapsed or refractory (R/R) FL who have received at least two prior systemic therapies. In January 2023, the use of mosunetuzumab was approved by the FDA under accelerated approval based on response rate.

Indication

Mosunetuzumab as monotherapy is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least two prior systemic therapies.

Associated Conditions
Relapsed or Refractory Follicular Lymphoma
Associated Therapies
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pharmabiz.com
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Chugai Pharma receives Japanese regulatory approval for Lunsumio for intravenous treatment of relapsed or refractory follicular lymphoma

Chugai Pharmaceutical Co., Ltd. received MHLW approval for Lunsumio, a CD20/CD3 bispecific antibody, treating relapsed or refractory follicular lymphoma. Lunsumio offers high response rates and durable remission, with treatment duration based on patient response. Approved in 61 countries, it's a new option for patients with limited treatment choices.
chugai-pharm.co.jp
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Chugai Obtains Regulatory Approval for “LUNSUMIO for Intravenous Infusion” for Relapsed or Refractory Follicular Lymphoma

Chugai Pharmaceutical Co., Ltd. received MHLW approval for LUNSUMIO®, a new treatment for relapsed or refractory follicular lymphoma, offering high response rates and potential durable remission. The treatment duration varies based on patient response, aiming to reduce treatment burden. Approval followed successful Japanese and overseas clinical trials.

ASH 2024: inMIND study results position Monjuvi as a promising therapy for R/R follicular lymphoma

The inMIND trial showed Monjuvi + Rituxan + Revlimid improved progression-free survival (PFS) to 22.4 months vs. 13.9 months for placebo in R/R follicular lymphoma. Key secondary endpoints also favored the experimental arm. Monjuvi aims to become a new standard-of-care option, with potential competition from other therapies.
gene.com
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Press Releases | Monday, Dec 9, 2024

New data at ASH 2024 show Genentech's Columvi and Lunsumio achieve durable remissions, reduce travel burden, and offer subcutaneous options, enhancing lymphoma treatment flexibility and patient experience.

Regeneron's Ordspono faces challenges, but positive results signal hope

Regeneron's Ordspono shows promise in treating r/r MZL with 77.1% ORR and CR rate, but faces challenges like low long-term adherence and regulatory delays. It received EU approval for r/r FL and DLBCL, but US market adoption is pending confirmatory trials. Competitors like AbbVie and Genmab's Epkinly pose threats with more convenient administration routes.
globenewswire.com
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New and updated data for Roche's fixed-duration Columvi

Roche presented new data on Columvi and Lunsumio at ASH 2024, showing durable remissions and reduced travel burden. Subcutaneous Lunsumio demonstrated non-inferiority to IV treatment, offering a shorter administration time. These results support Roche's efforts to innovate lymphoma treatments.

AstraZeneca set to take a BiTE out of follicular lymphoma market

AstraZeneca presented interim results of AZD0486, a CD19xCD3 BiTE, at ASH 2024, showing 96% ORR and 85% CR in r/r FL patients. AZD0486's CRS rate of 45% with all grade 1 events compares favorably to Epkinly and similarly to Lunsumio. A phase II trial is underway, with potential for first-in-class approval and $158 million in global sales by 2030.
pharmabiz.com
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US FDA accepts sBLA for Roche's Columvi combination for people with relapsed

Roche's sBLA for Columvi (glofitamab) in combination with gemcitabine and oxaliplatin (GemOx) for relapsed or refractory diffuse large B-cell lymphoma (DLBCL) has been accepted by the FDA, with a decision expected by 20 July 2025. The phase III STARGLO study showed Columvi plus GemOx significantly improved overall survival versus MabThera/Rituxan and GemOx, making it the first CD20xCD3 bispecific antibody to demonstrate a survival benefit in DLBCL in a randomized phase III trial. Safety was consistent with individual medicines' profiles.
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