First-in-Class Bispecific Antibody Mosunetuzumab-axgb Receives FDA Approval for Follicular Lymphoma
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For adults with follicular lymphoma relapsing or resistant after two or more systemic treatments, mosunetuzumab-axgb (Lunsumio) received accelerated FDA (US Food and Drug Administration) approval on 22 December 2022.
Follicular lymphoma, which arises from B cells, is a usually slow-growing, low-grade non-Hodgkin lymphoma. It is called follicular because abnormal B cells often grow in clusters called follicles within lymph nodes. It is the most common lymphoma type and generally occurs more frequently in middle-aged and older men. Treatment options include chemotherapy, radiotherapy and medicines such as immunotherapies.
What Is Mosunetuzumab and How Does It Work?
Mosunetuzumab binds CD20 on cancerous B-cell surfaces and CD3 on cytotoxic T cells, leading to cross-linking of the T-cell receptor and activation of an immunological T-cell response. In preclinical lymphoma models, it induced T-cell proliferation and B-cell death. Mosunetuzumab is an off-the-shelf product and does not require manufacturing time.
A First-in-Class Bispecific Antibody Immunotherapy
Mosunetuzumab-axgb is a bispecific antibody targeting CD20/CD3 T cells. It is first in its class and is a form of cancer immunotherapy. Continued approval for this use may depend on verification and description of clinical benefit in a confirmatory trial.
Lunsumio received accelerated approval based on response rates reported in the phase II GO29781 study. GO29781 is a multicentre, open-label, dose-escalation and dose-expansion study evaluating the safety, efficacy and pharmacokinetics of mosunetuzumab-axgb in people with relapsed or resistant B-cell non-Hodgkin lymphoma. Outcomes were independently assessed complete response rate (best response), the primary endpoint, and objective response rate, response duration and progression-free survival, the secondary endpoints.
Details of the GO29781 Study Leading to FDA Approval
The results showed high, sustained response rates.
- A targeted response occurred in 80% of patients treated with mosunetuzumab-axgb, and most of these patients (57%) maintained responses for at least 18 months.
- Median response duration among responders was 22.8 months.
- A complete response occurred in 60% of treated patients.
Among 218 lymphoma patients receiving mosunetuzumab-axgb at the recommended dose, the most common adverse effect was cytokine release syndrome, with an average duration of 3 days. Other common adverse effects (≥20%) were fatigue, itching, fever and headache.
Mosunetuzumab-axgb is given by intravenous infusion in a hospital setting. Hospital admission may be required to manage certain adverse effects.
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