Drug updated on 9/4/2024
Dosage Form | Injection (intravenous; 1 mg/mL, 30 mg/30 mL [1 mg/mL] single-dose vials) |
Drug Class | CD20-directed CD3 T-cell engagers |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- For the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
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Summary
- Lunsumio (mosunetuzumab-axgb) is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
- This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
- Overall Response Rate (ORR) and Complete Response (CR): Mosunetuzumab demonstrated an ORR of 80% and a CR rate of 60% in the clinical trial cohort, compared to an ORR of 75% and a CR rate of 33% in the real-world data (RWD) cohort.
- Progression-Free Survival (PFS) and Overall Survival (OS): Mosunetuzumab had a hazard ratio for PFS of 0.82 (95% CI, 0.53-1.27) and for OS of 0.43 (95% CI, 0.19-0.94) when compared to a RWD cohort, with MAIC results favoring mosunetuzumab over tazemetostat in EHZ2wild-type patients and PI3K inhibitors for CR, ORR, discontinuations due to adverse events, and PFS.
- Comparisons with Other Therapies: Mosunetuzumab showed superior outcomes compared to tazemetostat in EHZ2wild-type patients for all effectiveness measures and better outcomes than PI3K inhibitors for CR, ORR, discontinuations due to adverse events, and PFS, with mixed results observed against anti-CD20 antibody-based regimens and CART therapies.
- There is no detailed safety information available in the reviewed studies.
- Mosunetuzumab had fewer discontinuations due to adverse events compared to PI3K inhibitors, as noted in the MAIC results.
- The reviewed studies focus on patients with relapsed/refractory follicular lymphoma (RR FL) who have undergone two or more prior lines of therapy, with specific findings indicating that mosunetuzumab shows superior effectiveness in EHZ2wild-type patients compared to tazemetostat.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Lunsumio (mosunetuzumab-axgb) Prescribing Information. | 2022 | Genetech Inc., South San Francisco, CA |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
Indirect Treatment Comparisons of Mosunetuzumab With Third- and Later-Line Treatments for Relapsed/Refractory Follicular Lymphoma. | 2024 | Clinical Lymphoma, Myeloma & Leukemia |
Comparative effectiveness between mosunetuzumab monotherapy clinical trial and real-world data in relapsed/refractory follicular lymphoma in third or subsequent lines of systemic therapy. | 2023 | Leukemia & Lymphoma |
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Bispecific antibodies as monotherapy or in combinations for hematological malignancies: Latest updates from the EHA 2023 annual meeting. | 2023 | Expert opinion on biological therapy |
NCCN Guidelines® Insights: B-Cell Lymphomas, Version 6.2023 | 2023 | National Comprehensive Cancer Network |