MedPath

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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Roche to present more than 40 abstracts across nine blood disorders at the 66th ASH meeting

Roche to present over 40 abstracts on nine blood disorders at ASH 2024, highlighting long-term follow-up data for Polivy, Lunsumio, and Columvi, and new investigational combinations. Key findings include durable remissions and positive trends in overall survival for DLBCL, long-lasting remissions and immune recovery for FL and DLBCL, and potential benefits of subcutaneous Lunsumio. Patient-reported outcomes support Columvi's benefits in DLBCL. Roche continues to innovate in hematology with a broad portfolio and pipeline.

Genentech to present blood disorders data at ASH

Genentech to present over 40 abstracts on blood disorders at ASH 2023, highlighting long-term follow-up data for Polivy, Lunsumio, and Columvi, showing durable remissions and potential OS improvements in DLBCL. New subcutaneous Lunsumio data indicate deep, durable responses and low cytokine release syndrome. Patient-reported outcomes from STARGLO study support Columvi's benefits in DLBCL. Updated data on Polivy combinations with bispecific antibodies suggest potential in earlier treatment lines.
morningstar.com
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Genentech to Present New and Encouraging Long-term Follow-up Data Across ...

Genentech to present over 40 abstracts on long-term follow-up data for its hematology portfolio at ASH 2024, including five-year data from the POLARIX study showing Polivy's potential in first-line DLBCL, extended follow-up data for Lunsumio and Columvi demonstrating long-lasting remissions, and new patient-reported outcomes from the STARGLO study.
finance.yahoo.com
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Genentech to Present New and Encouraging Long-term Follow-up Data Across Broad

Genentech presents key studies on Polivy, Lunsumio, Columvi, Venclexta, Hemlibra, and PiaSky at medical conferences, highlighting efficacy and safety profiles of these medicines in treating various blood cancers and hemophilia A.
billingsgazette.com
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Clinical research milestone in Billings means hope for Montana residents

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Roche announces positive results from phase III study of Gazyva/Gazyvaro in people with ...

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Global Bispecific Antibodies Clinical Trials Market Size

Bispecific antibodies market highlights include >30 development platforms, >USD 8B market size in 2023, and >800 clinical trials. Key approved antibodies like Blincyto and Hemlibra have seen significant sales. The market is driven by innovations in immuno-oncology, with ongoing trials by major pharma companies and research institutions globally.
gene.com
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Press Releases | Wednesday, Sep 25, 2024

Genentech announced positive Phase III REGENCY study results for Gazyva, showing it plus standard therapy achieved a higher complete renal response rate in active lupus nephritis patients compared to standard therapy alone, with no new safety signals.
finance.yahoo.com
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finance.yahoo.com
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Biogen Inc. (BIIB) Down 0.2% Since Last Earnings Report: Can It Rebound?

Biogen Inc. reported Q2 2023 earnings of $4.02 per share, beating estimates, despite a 23% year-over-year decline. Sales fell 5% to $2.46 billion, impacted by lower MS drug sales. MS revenues dropped 15%, with Tecfidera sales down 36%. Spinraza sales rose 1% to $437 million. Biogen expects MS revenues to decline in 2023 due to competition. The company is focusing on cost-saving initiatives and restructuring, aiming for $1 billion in savings by 2025.
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