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.
- FDA approves Roche’s Lunsumio, a first-in-class bispecific antibody, to treat people with relapsed or refractory follicular lymphoma. News release. Roche. December 23, 2022. Accessed December 27, 2022. https://www.globenewswire.com/news-release/2022/12/23/2579214/0/en/FDA-approves-Roche-s-Lunsumio-a-first-in-class-bispecific-antibody-to-treat-people-with-relapsed-or-refractory-follicular-lymphoma.html.
- Lunsumio. Package insert. Roche; 2022. Accessed December 27, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761263s000lbl.pdf.
This article originally appeared on MPR