Lunsumio Approved for Relapsed or Refractory Follicular Lymphoma

The US Food and Drug Administration (FDA) has granted accelerated approval to Lunsumio (mosunetuzumab-axgb) for the treatment of adults with relapsed or refractory follicular lymphoma (FL) after 2 or more lines of systemic therapy.

Mosunetuzumab-axgb is a T-cell engaging bispecific antibody that targets CD20 on the surface of B cells and CD3 on the surface of T cells.

The FDA approval was based on data from an open-label, phase 2 study (GO29781; ClinicalTrials.gov Identifier: NCT02500407), which was designed to evaluate the efficacy, safety and pharmacokinetics of mosunetuzumab-axgb in adults with relapsed/refractory FL who had received at least 2 prior therapies, including an anti-CD20 monoclonal antibody and an alkylating agent.

Mosunetuzumab-axgb induced durable responses in these patients. The objective response rate was 80% (n=72/90), and the complete response rate was 60%. The median duration of response was 22.8 months, with a majority of patients maintaining a response for at least 12 months (62%) or 18 months (57%). The median time to first response was 1.4 months (range, 1.1 to 8.9).

Mosunetuzumab-axgb carries a Boxed Warning that notes the risk of cytokine release syndrome (CRS), including serious or life-threatening reactions.

The most common adverse reactions (incidence of 20% or higher) seen with mosunetuzumab-axgb were CRS, fatigue, rash, pyrexia, and headache. The most common grade 3-4 laboratory abnormalities (incidence at least 10%) were decreased lymphocyte count, decreased phosphate, increased glucose, decreased neutrophil count, increased uric acid, decreased white blood cell count, decreased hemoglobin, and decreased platelets.

Lunsumio is supplied as a single-dose vial containing 1 mg/mL or 30 mg/30 mL preservative-free solution of mosunetuzumab-axgb. Treatment is administered only as an intravenous infusion. The product is expected to be available in the coming weeks.

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