The European Commission has granted conditional marketing authorization to subcutaneous (SC) mosunetuzumab (Lunsumio) for the treatment of adult patients with relapsed/refractory follicular lymphoma following at least 2 lines of systemic therapy.1
SC Mosunetuzumab Approved by the Europe Commission in R/R Follicular Lymphoma
- The European Commission has granted conditional marketing authorization to SC mosunetuzumab in adult patients with relapsed/refractory follicular lymphoma after at least 2 lines of systemic therapy.
- The approval was supported by data from the primary analysis of the phase 1/2 GO29781 trial, which showed that patients who received SC mosunetuzumab experienced similar efficacy outcomes compared with the IV formulation.
- Long-term data from GO29781 will be presented at the 2025 ASH Annual Meeting and Exposition.
The approval was supported by data from the phase 1/2 GO29781 trial (NCT02500407), which compared SC mosunetuzumab with intravenous (IV) administration of the agent in patients with relapsed/refractory follicular lymphoma.2 Findings from the primary analysis of GO29781 demonstrated that SC mosunetuzumab displayed pharmacokinetic noninferiority compared with the IV formulation.1 The overall response rate (ORR) among patients who received the fixed-duration, SC formulation was 74.5% (95% CI, 64.4%-82.9%); the complete response (CR) rate was 58.5% (95% CI, 46.9%-68.6%). The median duration of CR was 20.8 months (95% CI, 18.8-not evaluable [NE]).
“Building on the benefits of its fixed-duration dosing schedule, [mosunetuzumab] can now be administered with a one-minute subcutaneous injection, providing people with relapsed or refractory follicular lymphoma an additional treatment option to help meet their individual clinical requirements and lifestyle preferences,” Levi Garraway, MD, PhD, chief medical officer and head of global product development at Roche, stated in a news release. “Developing new formulations of our medicines is part of our commitment to offering greater flexibility and a better treatment experience for patients.”
What were the key design characteristics of the GO29781 study?
GO29781 was an open-label, multicenter study that enrolled patients with histologically confirmed grade 1 to 3a follicular lymphoma.2 Patients were required to have relapsed/refractory disease following treatment with at least 2 systemic therapies, including a prior anti-CD20 agent and an alkylator therapy. An ECOG performance status of 0 or 1 was also necessary for enrollment.
Patients received IV or SC mosunetuzumab. In the IV arm (n = 90), patients received the agent on days 1, 8, and 16 of cycle 1 at respective doses of 1 mg, 2 mg, and 60 mg; on day 1 of cycle 2 at 60 mg; on day 1 of cycle 3 through 8 at 30 mg. In the SC arm (n = 94), mosunetuzumab was administered at 5 mg, 45 mg, and 45 mg on days 1, 8, and 15 of cycle 1, respectively, as well as at 45 mg on day 1 of cycles 2 through 8. In both arms, patients with a partial response or stable disease after cycle 8 continued treatment for up to cycle 17, using the same dosing schedule given in cycle 8.
