Mosunetuzumab

Mosunetuzumab-axgb is a T-cell engaging bispecific antibody that binds to the CD3 receptor expressed on the surface of T-cells and CD20 expressed on the surface of lymphoma cells and some healthy B-lineage cells. In vitro, mosunetuzumab-axgb activated T-cells, caused the release of proinflammatory cytokines, and induced lysis of B-cells.

• LUNSUMIO is a bispecific CD20-directed CD3 T-cell engager indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate.ICD-10: C85.90

• None. None.contraindicated

LUNSUMIO and LUNSUMIO VELO have different dosage and administration instructions. Administer LUNSUMIO only as an intravenous infusion. ( 2.1 ) Premedicate to reduce risk of CRS and infusion-related reactions. ( 2.3 , 5.1 ) Recommended dosage for LUNSUMIO for intravenous infusion ( 2.2 ): Day of Treatment Cycle length = 21 days Intravenous Dose of LUNSUMIO Rate of Infusion Cycle 1 Day 1 1 mg Administer over a minimum of 4 hours. Day 8 2 mg Day 15 60 mg Cycle 2 Day 1 60 mg Administer over 2 hours if infusions from Cycle 1 were well-tolerated. Cycles 3+ Day 1 30 mg See Full Prescribing Information for instructions on preparation and administration. ( 2.5 ) 2.1 Important Dosing Information LUNSUMIO and LUNSUMIO VELO have different dosage and administration instructions [see Dosage and Administration (2.2) and Warnings and Precautions (5.7) ]. LUNSUMIO is for intravenous use only. Check the product label to ensure that the correct formulation (LUNSUMIO or LUNSUMIO VELO) is being prescribed and administered. Do not substitute LUNSUMIO for or with LUNSUMIO VELO. Administer LUNSUMIO to well-hydrated patients. Premedicate before each dose in Cycle 1 and Cycle 2 [see Dosage and Administration (2.3) ] . Administer only as an intravenous infusion through a dedicated infusion line. Do not use an in-line filter to administer LUNSUMIO . Drip chamber filters can be used to administer LUNSUMIO.

Neurologic Toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome : Can cause serious and life-threatening neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS). Monitor patients for signs and symptoms of neurologic toxicity during treatment; withhold or permanently discontinue based on severity. ( 5.2 ) Infections : Can cause serious or fatal infections. Monitor patients for signs and symptoms of infection, including opportunistic infections, and treat as needed. ( 5.3 ) Hemophagocytic Lymphohistiocytosis: Can cause serious or fatal reactions. For suspected cases, interrupt LUNSUMIO and evaluate and treat promptly. ( 5.4 ) Cytopenias : Monitor complete blood cell counts during treatment. ( 5.5 ) Tumor Flare : Can cause serious tumor flare reactions. Monitor patients at risk for complications of tumor flare. ( 5.6 ) Risk of Medication Errors with Incorrect Product Use : Ensure that the correct formulation is being prescribed, dispensed, and administered. ( 5.7 ) Embryo-Fetal Toxicity : May cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus and to use effective contraception. ( 5.8 , 8.1 , 8.3 ) 5.1 Cytokine Release Syndrome LUNSUMIO can cause CRS, including serious or life-threatening reactions [see Adverse Reactions (6.1 )] . CRS occurred in 39% of patients who received LUNSUMIO at the recommended dosage in the clinical trial, with Grade 1 CRS occurring in 28%, Grade 2 in 15%, Grade 3 in 2%, and Grade 4 in 0.5% of patients.

The following adverse reactions are described elsewhere in the labeling: Cytokine Release Syndrome [see Warnings and Precautions (5.1) ] Neurologic Toxicity, including Immune Effector Cell-associated Neurotoxicity Syndrome [see Warnings and Precautions (5.2) ] Infections [see Warnings and Precautions (5.3) ] Hemophagocytic Lymphohistiocytosis [see Warnings and Precautions (5.4) ] Cytopenias [see Warnings and Precautions (5.5) ] Tumor Flare [see Warnings and Precautions (5.6) ] The most common adverse reactions (≥ 20%) in patients with follicular lymphoma are CRS, fatigue, rash, headache, pyrexia, musculoskeletal pain, cough, pruritus, and peripheral neuropathy. The most common Grade 3 to 4 laboratory abnormalities (≥ 10%) are decreased lymphocyte count, decreased phosphate, increased glucose, decreased neutrophil count, increased uric acid, decreased hemoglobin, and decreased platelets. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Genentech at 1-888-835-2555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The pooled safety population described in the WARNINGS AND PRECAUTIONS reflects exposure to LUNSUMIO as a single agent in GO29781 in 218 patients with hematologic malignancies in an open-label, multicenter, multi-cohort study.

Lactation: Advise not to breastfeed. ( 8.2 ) 8.1 Pregnancy Risk Summary Based on the mechanism of action, LUNSUMIO may cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . There are no available data on the use of LUNSUMIO in pregnant women to evaluate for a drug-associated risk. No animal reproductive or developmental toxicity studies have been conducted with mosunetuzumab-axgb. Mosunetuzumab-axgb causes T-cell activation and cytokine release; immune activation may compromise pregnancy maintenance. In addition, based on expression of CD20 on B-cells and the finding of B-cell depletion in non-pregnant animals, mosunetuzumab-axgb can cause B-cell lymphocytopenia in infants exposed to mosunetuzumab-axgb in-utero. Human immunoglobulin G (IgG) is known to cross the placenta; therefore, LUNSUMIO has the potential to be transmitted from the mother to the developing fetus. Advise women of the potential risk to the fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% – 4% and 15% – 20%, respectively. 8.2 Lactation Risk Summary There is no information regarding the presence of mosunetuzumab-axgb in human milk, the effect on the breastfed child, or milk production.

Metabolism

Mosunetuzumab-axgb PK exposure increased proportionally over a dose range from 0.2 mg to 60 mg (0.007 to 2 times the recommended treatment dosage). PK exposures for the recommended dosage of LUNSUMIO are summarized in Table 10 and Figure 1 .

• Dec 22, 2022BLABLA761263Genentech Inc

1. 1Cytokine Release Syndrome18022%
2. 2Disease Progression11414%
3. 3Neutropenia809.6%
4. 4Covid-19678.1%
5. 5Off Label Use637.6%
6. 6Pyrexia597.1%
7. 7Death475.6%
8. 8Pneumonia475.6%
9. 9Malignant Neoplasm Progression455.4%
10. 10Covid-19 Pneumonia404.8%
11. 11Disorientation313.7%
12. 12Neurological Symptom313.7%
13. 13Vasogenic Cerebral Oedema313.7%
14. 14Diffuse Large B-cell Lymphoma Recurrent283.4%
15. 15Rash283.4%

The 10 most recently updated of 55 ClinicalTrials.gov registrations naming Mosunetuzumab as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Mosunetuzumab or Glofitamab in Combination With CC-220 and/or CC-99282 in Participants With B-Cell Non-Hodgkin Lymphoma
  Recruiting · Phase 1 · Interventional · 121 enrolled · Hoffmann-La Roche
  NCT05169515updated 2026-06-12
• Comparing Rituximab and Mosunetuzumab Drug Treatments for People With Low Tumor Burden Follicular Lymphoma
  Recruiting · Phase 3 · Interventional · 600 enrolled · National Cancer Institute (NCI)
  NCT06337318updated 2026-06-11
• Testing Mosunetuzumab Alone, With Zanubrutinib, or With Polatuzumab Vedotin for Treating Marginal Zone Lymphoma That Came Back or Didn't Get Better With Treatment
  Not yet recruiting · Phase 2 · Interventional · 138 enrolled · SWOG Cancer Research Network
  NCT07638722updated 2026-06-10
• A Study to Evaluate the Safety and Anti-cancer Activity of Loncastuximab Tesirine in Combination With Other Anti-cancer Agents in Participants With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (LOTIS-7)
  Recruiting · Phase 1 · Interventional · 200 enrolled · ADC Therapeutics S.A.
  NCT04970901updated 2026-06-09
• Mosunetuzumab and Zeprumetostat in Treating Patients With Follicular Lymphoma
  Recruiting · Phase 2 · Interventional · 80 enrolled · Institute of Hematology & Blood Diseases Hospital, China
  NCT07555470updated 2026-06-09
• Study of Mosunetuzumab Plus Lenalidomide Compared to Anti-CD20 Anti-body + Chemotherapy in Follicular Lymphoma FLIPI2-5
  Recruiting · Phase 3 · Interventional · 790 enrolled · The Lymphoma Academic Research Organisation
  NCT06284122updated 2026-06-05
• Pirtobrutinib and Mosunetuzumab for the Treatment of Relapsed/Refractory Grades 1-3A Follicular Lymphoma, PROMOTE-FL Trial
  Recruiting · Phase 2 · Interventional · 22 enrolled · University of Washington
  NCT06948786updated 2026-06-04
• A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Mosunetuzumab and a Combined Regimen of Mosunetuzumab and Venetoclax in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia
  Recruiting · Phase 1 · Interventional · 137 enrolled · Hoffmann-La Roche
  NCT05091424updated 2026-06-03
• A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Mosunetuzumab Monotherapy in Participants With Select B-Cell Malignancies
  Active not recruiting · Phase 2 · Interventional · 320 enrolled · Genentech, Inc.
  NCT05207670updated 2026-06-03
• A Study to Investigate Safety and Effectiveness of BGB-16673 in Combination With Other Agents in Participants With Relapsed or Refractory B-Cell Malignancies
  Recruiting · Phase 1 · Phase 2 · Interventional · 80 enrolled · BeOne Medicines
  NCT06634589updated 2026-06-03

Frequently asked questions

How does Mosunetuzumab work?

Mosunetuzumab-axgb is a T-cell engaging bispecific antibody that binds to the CD3 receptor expressed on the surface of T-cells and CD20 expressed on the surface of lymphoma cells and some healthy B-lineage cells. In vitro, mosunetuzumab-axgb activated T-cells, caused the release of proinflammatory cytokines, and induced lysis of B-cells.

What is Mosunetuzumab used for?

According to FDA labeling, Mosunetuzumab carries indications including: LUNSUMIO is a bispecific CD20-directed CD3 T-cell engager indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Mosunetuzumab?

Mosunetuzumab is classified as Other monoclonal antibodies and antibody drug conjugates, CD20-directed Antibody Interactions, CD3-directed Antibody Interactions, Increased Cytokine Production.

What are the brand names for Mosunetuzumab?

Mosunetuzumab is marketed under brand names including Lunsumio.

What are the contraindications for Mosunetuzumab?

Mosunetuzumab labeling lists contraindications including: None. None.. Always consult the full prescribing information and a clinician.