Roche subcutaneous formulation of Lunsumio recommended by CHMP for EU nod for follicular lymphoma
Basel: Roche has announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of a subcutaneous (SC) formulation of Lunsumio (mosunetuzumab) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy. A final decision is expected from the European Commission in the near future.
"Lunsumio was the first-ever approved CD20xCD3 T-cell engaging bispecific antibody demonstrating high, durable response rates and a favourable safety profile in third-line or later follicular lymphoma," said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. "If approved, the subcutaneous formulation could help to expand the treatment options available, offering people a fixed-duration therapy with a faster treatment administration time."
The CHMP opinion is based on results from a primary analysis of the phase II GO29781 study. Data show subcutaneous Lunsumio had pharmacokinetic non-inferiority compared to intravenous (IV) administration, with no unexpected safety signals. Overall, the rate and severity of cytokine release syndrome was low (29.8%); events were low grade (Grade 1-2, 27.7%; Grade 3, 2.1%), occurred during cycle 1 and all fully resolved in a median of two days (range 1-15 days).
Lunsumio administered subcutaneously has the potential to reduce the treatment administration time with an approximately one minute injection, compared with 2-4 hours for IV infusion, while retaining the same dosing schedule. Lunsumio is designed to be given for a fixed duration of approximately 6-12 months, depending on a patient’s response to treatment, and can be initiated in the outpatient setting. This means people have a target end date for their course of treatment and the possibility of a treatment-free period.
Data from the phase II GO29781 study have been submitted to other health authorities around the world for approval consideration, including the US Food and Drug Administration.
Lunsumio, along with Columvi (glofitamab), is part of Roche’s CD20xCD3 bispecific antibody portfolio.
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