Roche has received conditional marketing authorisation from the European Commission (EC) for Lunsumio (mosunetuzumab) to treat adult patients with relapsed or refractory (R/R) follicular lymphoma (FL).
The antibody is indicated to treat R/R FL patients who have received at least two prior systemic therapies.
Lunsumio is a CD20xCD3 T-cell engaging bispecific antibody that targets CD20 on the surface of B-cells and CD3 on the T-cells surface.
The company stated that the antibody is a new immunotherapy type which is a chemotherapy-free, fixed-duration, off-the-shelf treatment option that helps in improving the outcomes for patients with R/R to multiple previous treatments.
Roche Global Product Development head and chief medical officer Levi Garraway said: “We are delighted that Lunsumio is the first bispecific antibody approved in Europe for people with relapsed or refractory follicular lymphoma.
“Lunsumio’s high response rates, off-the-shelf availability, and initial outpatient administration could transform how advanced follicular lymphoma is treated.”
The regulatory approval is based on data obtained from the open-label, multicentre, dose-escalation and expansion Phase I/II GO29781 study.
The trial was designed to assess the efficacy, pharmacokinetics, and safety of Lunsumio in patients with R/R B-cell non-Hodgkin lymphoma.
According to the results of the study, Lunsumio showed high complete response rates, and favourable tolerability in heavily pre-treated FL patients.
The complete response rate, the objective response rate and the median duration of response in responders was 60%, 80% and 22.8 months, respectively, after a median follow-up of 18.3 months.
The most common adverse events observed in the study were cytokine release syndrome, pyrexia, hypophosphatemia, headache, and neutropenia.