Roche’s Lunsumio (mosunetuzumab) has been given a Priority Review by the US Food and Drug Administration (FDA) following its acceptance of the company’s Biologics License Application.
Lunsumio is a potential first-in-class CD20xCD3 T-cell engaging bispecific antibody and it has been developed for the treatment of adults with relapsed or refractory (R/R) follicular lymphoma (FL) who have received at least two prior systemic therapies.
Follicular lymphoma is the most common, slow-growth type of non-Hodgkin lymphoma (NHL) – a form of blood cancer – which often returns after a first therapy. Follicular lymphoma usually becomes more difficult to treat each time a patient relapses. In the US, estimates show around 13,000 new cases of FL will be diagnosed in 2022.
The FDA is expected to decide on the approval of the novel cancer immunotherapy by 29 December 2022.
If the treatment is approved, Lunsumio could be the first CD20xCD3 T-cell engaging bispecific antibody approved by the FDA for the treatment of any type of non-Hodgkin lymphoma.
“New therapeutic options are needed for follicular lymphoma, which often relapses after initial therapy and becomes increasingly difficult to treat each time it returns. Clinical trial results have demonstrated durable responses with Lunsumio in advanced follicular lymphoma, representing a step toward shifting the treatment paradigm,” said Levi Garraway, Roche’s chief medical officer and head of global product development.
He added: “Since Lunsumio does not require the collection or genetic modification of patient cells, it could become an effective, fixed-duration outpatient option without the barriers of travelling to a major academic centre.”
The BLA is based on positive results from the pivotal phase 1/2 GO29781 study of Lunsumio, which showed high complete response (CR) rates, with the majority of patients continuing to respond for at least 18 months, and manageable tolerability in people with heavily pretreated follicular lymphoma.
After a median follow-up of 18.3 months, the CR rate was 60% and the objective response rate was 80%, while the median duration of response among those who responded was 22.8 months.
The European Commission issued a conditional marketing authorisation for Lunsumio in June 2022 for patients with R/R follicular lymphoma who have received at least two prior systemic therapies.