Lunsumio

Relapsed or refractory follicular lymphoma (FL) after two or more prior lines of systemic therapy.

Step-up dosing schedule:
Cycle 1: Day 1: 1 mg IV, Day 8: 2 mg IV, Day 15: 60 mg IV
Cycle 2: Day 1: 60 mg IV
Cycle 3: Day 1: 30 mg IV
Cycles 4-8: Day 1: 30 mg IV (each cycle is 21 days)
Infusion time: Cycle 1 Day 1/Day 8: minimum 4 hours; subsequent infusions minimum 2 hours
Pre-medication: Corticosteroid + antihistamine + antipyretic before each dose in Cycle 1; Cycle 2+ based on judgment
Duration: Fixed 8 cycles or until progression/unacceptable toxicity

Injection: 1 mg/mL in single-dose vials (1 mg/1 mL and 30 mg/30 mL)

None listed.

• Cytokine Release Syndrome (CRS): Occurred in 39% (1.2% Grade 3). Median onset: 5 hours. Most events in Cycle 1. Pre-medicate. Manage with tocilizumab if needed.
• Neurologic Toxicity (ICANS): In 4%. Includes confusional state, tremor, dizziness.
• Infections: Serious infections in 14%. Including fatal infections, COVID-19 pneumonia, and HBV reactivation. Screen for HBV before starting.
• Tumor Flare: In 3%. Localized pain/swelling at tumor sites.
• Cytopenias: Neutropenia (24%), anemia (13%), thrombocytopenia (10%).

Cytokine release syndrome (39%), fatigue (25%), rash (20%), headache (18%), pyrexia (17%), diarrhea (15%), upper respiratory tract infection (14%), neutropenia (24%), hypophosphatemia (15%)

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

Consult the complete prescribing information for drug interactions, including effects on CYP enzymes, transporters, and concomitant medications that may require dose adjustments or monitoring.

Consult the full prescribing information for pregnancy-related considerations.

Refer to prescribing information for lactation guidance.

Pediatric safety and efficacy information is detailed in the full label.

Dose modifications for organ impairment are specified in the complete prescribing information.

Mosunetuzumab is a bispecific antibody that bridges CD20-expressing B-cell lymphoma cells and CD3-expressing T cells. It binds CD20 on tumor cells and CD3ε on T cells simultaneously, forming an immunological synapse that activates T cells to release cytotoxic granules (perforin and granzymes), resulting in lysis of CD20-positive tumor cells. This mechanism is independent of T-cell receptor specificity or MHC class I restriction.

Half-life: approximately 16 days at 30 mg. Non-linear PK at lower doses due to target-mediated drug disposition. Steady-state approached by Cycle 3. Clearance decreases with repeated dosing as CD20+ B cells are depleted.

Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.

• GO29781 — Mosunetuzumab in relapsed/refractory follicular lymphoma after ≥2 prior therapies. Phase I/II.
  🔬 NCT02500407 ↗ 📄 Primary Publication ↗

Lunsumio has FDA-approved indications across the following cancer types covered on PipelineEvidence: