Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.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).
Lunsumio is indicated to treat adult patients with relapsed or refractory follicular lymphoma. Credit: Nephron / commons.wikimedia.org.
Subscribe to our email newsletter
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.
