The approval was based on positive results from the phase II GO29781 study of Lunsumio which showed high and durable response rates in people with heavily pre-treated FL
Roche has secured approval from the US Food and Drug Administration (FDA) for its Lunsumio (mosunetuzumab-axgb) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL).
The Switzerland-based firm has developed the drug for treatment after two or more lines of systemic therapy. The new indication is approved under accelerated approval based on the response rate.
Lunsumio is said to be a CD20xCD3 T-cell-engaging bispecific antibody designed to target CD20 on the surface of B-cells and CD3 on the surface of T-cells. To be available in the US in the coming weeks, the drug represents a new range of fixed-duration cancer immunotherapy.
The FDA approval is supported by positive results from the phase II GO29781 study of Lunsumio in people with heavily pre-treated FL.
Roche said that the trial showed high and durable response rates which include an objective response rate (ORR) in 80% of patients treated with Lunsumio, with a majority maintaining responses for at least 18 months. The median duration of response was almost two years.
Additionally, a complete response (CR) rate was achieved in 60% of patients. The median duration of CRS events was three days, the pharmaceutical firm said.
Roche chief medical officer and global product development head Levi Garraway said: “Despite treatment advances, follicular lymphoma remains incurable and relapse is common, with outcomes worsening following each consecutive treatment.
“Lunsumio represents our first approved T-cell engaging bispecific antibody and builds on our legacy of more than 20 years of innovation in blood cancer.”
The GO29781 study is said to be a phase II, multicentre, open-label, dose-escalation and expansion study. It assessed the safety, efficacy and pharmacokinetics of Lunsumio in adults with relapsed or refractory B-cell non-Hodgkin lymphoma.
As per the firm, Lunsumio is given as an intravenous infusion for a fixed-duration for time off therapy in an outpatient setting. It is intended for patients with blood cancer, physicians, and practice settings.