Roche gets USFDA priority review for Lunsumio to treat relapsed or refractory follicular 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, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product Development. "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 I/II GO29781 study of Lunsumio, which showed high complete response (CR) rates, with the majority of responders (57% [95% CI: 49-70]) maintaining responses for at least 18 months, and manageable tolerability in people with heavily pretreated FL. After a median follow-up of 18.3 months, the CR rate was 60% (n=54/90) and the objective response rate was 80% (n=72/90). The median duration of response among those who responded was 22.8 months (95% CI: 9.7-not estimable). Treatment was administered without mandatory hospitalisation. Results were presented for the first time in December 2021 at the 63rd American Society of Hematology (ASH) Annual Meeting & Exposition.

Priority Review designation is granted to medicines that the FDA considers to have the potential to provide significant improvements in the safety and effectiveness of the treatment, prevention or diagnosis of a serious disease. The FDA granted Breakthrough Therapy designation (BTD) to Lunsumio for the treatment of adults with R/R FL who have received at least two prior systemic therapies in June 2020 and Orphan Drug Designation in December 2018. BTD is designed to accelerate the development and review of medicines intended to treat serious or life-threatening conditions with preliminary evidence that indicates they may demonstrate substantial improvement over existing therapies. The European Commission granted conditional marketing authorisation for Lunsumio for the treatment of people with R/R FL who have received at least two prior systemic therapies in June 2022.

A robust development programme for Lunsumio is ongoing including two phase III studies: CELESTIMO investigating Lunsumio plus lenalidomide in second line plus (2L+) FL, and SUNMO, investigating Lunsumio plus Polivy (polatuzumab vedotin) in 2L+ diffuse large B-cell lymphoma (DLBCL).