Roche reported positive Phase III trial results Thursday for Lunsumio (mosunetuzumab) in patients with follicular lymphoma, a common form of blood cancer, and said it plans to seek expanded regulatory approval based on the data.
The Celestimo study found that Lunsumio combined with the drug lenalidomide significantly reduced the risk of disease progression compared with a comparator therapy of rituximab plus lenalidomide in patients who had already received at least one prior treatment, the pharmaceutical giant said.
The trial's primary endpoint — an improvement in progression-free survival — was reached at an interim analysis. Data on overall survival were not yet mature at the time of the review.
Lunsumio is already approved in approximately 60 countries for patients with follicular lymphoma who have had at least two prior treatments fail. With the new trial results, Roche aims to convert the existing approval into a full marketing authorization and also pursue a regulatory indication for earlier use beginning at the second line of treatment.
Roche said it will submit the data to health authorities and present the findings at an upcoming medical conference.
