Roche’s Lunsumio Lands FDA Approval for Pretreated Follicular Lymphoma

After gaining European approval in June, Roche’s bispecific antibody, Lunsumio, snagged another win with accelerated approval from the FDA to treat relapsed or refractory follicular lymphoma. With its new status, the drug has the opportunity to compete with its CAR-T competitors like Yescarta and Kymriah.

Promising Clinical Data Supporting the FDA’s Decision

The FDA based its approval on data from the Phase 2 GO29781 study, which enrolled 90 participants with relapsed or refractory follicular lymphoma. The disease is the most common slow-growing form of non-Hodgkin lymphoma. Follicular lymphoma can respond to treatment but often returns, prompting another form of treatment. As a patient undergoes more and more treatments, attaining remission typically becomes more difficult. 

Because Roche applied for accelerated approval, the GO29781 study used surrogate endpoints like overall response rate to measure Lunsumio’s success in treating follicular lymphoma. About 80% of Lunsumio patients throughout the trial experienced an objective response. Roche characterized an objective response as a combination of complete and partial response rates. Among those who responded to Lunsumio, the median response duration lasted 22.8 months. 

Roche designed Lunsumio as a CD20xCD3 T-cell engaging bispecific antibody that targets CD20 on B-cell surfaces and CD3 on T-cell surfaces. This process allows existing T-cells to engage and eliminate target B-cells by releasing cytotoxic proteins. 

Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development, said, “Lunsumio represents our first approved T-cell engaging bispecific antibody and builds on our legacy of more than 20 years of innovation in blood cancer.”

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Sizing Up the CAR-T Competition

Some other new and promising developments in follicular lymphoma treatments include autologous CAR-T cell therapies like Kite’s Yescarta and Novartis’ Kymriah. Lunsumio is now in direct competition with these revolutionary therapies. 

Lunsumio has some benefits that CAR-T cell therapies can not compete within their current state. For example, some patients can receive Lunsumio in an outpatient setting if they meet certain criteria. This could cut down costs on healthcare and make it more convenient for patients. The intravenous infusion is also administered for a fixed duration, allowing time off therapy.

Despite CAR-T cell therapies’ impressive track record so far, they are expensive and time-consuming. Kymriah can cost $475,000 per treatment regimen, and Yescarta around $373,000. Patients also have to undergo tests and have samples taken for scientists to manufacture the personalized therapy. 

Roche has yet to confirm how much Lunsumio will cost, but the off-the-shelf antibody will likely be less than autologous CAR-T cell therapies. The company has high hopes for the drug in the U.S. market. Biogen will also reap some of those rewards after laying down $30 million in February for low single-digit royalties from sales in America. 

The most recent accelerated approval for Roche’s Lunsumio is an exciting development that will add another treatment option for patients with relapsed or refractory follicular lymphoma. The company said it would roll the drug out to the market in the coming weeks, and 2023 will see whether or not it holds a flame to its CAR-T cell competitors. 

Author

Reed Slater