The Food and Drug Administration (FDA) has granted accelerated approval to Lunsumio® (mosunetuzumab-axgb) for the treatment of adults with relapsed or refractory (R/R) follicular lymphoma (FL) after 2 or more lines of systemic therapy.
Mosunetuzumab-axgb is a first-in-class CD20xCD3 T-cell engaging bispecific antibody that targets CD20 on the surface of B cells and CD3 on the surface of T cells. The approval was based on data from an open-label, multicenter, multi-cohort phase 2 study (GO29781; ClinicalTrials.gov Identifier: NCT02500407), which evaluated the efficacy, safety and pharmacokinetics of mosunetuzumab-axgb in adults with R/R FL who had received at least 2 prior therapies, including an anti-CD20 monoclonal antibody and an alkylating agent.
Results showed mosunetuzumab-axgb induced high and durable response rates, with an objective response rate of 80% (n=72/90 [95%CI, 70-88]), of which 60% achieved complete response and 20% achieved partial response. The median duration of response (DOR) was 22.8 months (95% CI, 10-not reached), with a majority of patients maintaining response for at least 12 (62% [95% CI, 50-74]) and 18 months (57% [95% CI, 44-70]). The median time to first response was 1.4 months (range, 1.1 to 8.9).
As for safety, mosunetuzumab-axgb carries a Boxed Warning associated with a risk of cytokine release syndrome (CRS), including serious or life-threatening reactions. The most common adverse reactions (incidence at least 20%) for mosunetuzumab-axgb were CRS, fatigue, rash, pyrexia, and headache. The most common Grade 3 or 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.
“This approval is a significant milestone for people with relapsed or refractory follicular lymphoma, who have had limited treatment options until now,” said Elizabeth Budde, MD, PhD, Haematologic Oncologist and Associate Professor, City of Hope Division of Lymphoma, Department of Hematology & Hematopoietic Cell Transplantation, and Lunsumio clinical trial investigator. “As a first-in-class T-cell engaging bispecific antibody that can be initiated in an outpatient setting, Lunsumio’s high response rates and fixed-duration could change the way advanced follicular lymphoma is treated.”
Lunsumio is supplied as a single-dose vial containing 1mg/mL or 30mg/30mL 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