FDA Approves Lunsumio to Treat Relapsed/Refractory Follicular Lymphoma

Patients with relapsed/refractory follicular lymphoma — a group that traditionally has limited treatment options — now have a new bispecific antibody available.

The Food and Drug Administration (FDA) approved Lunsumio (mosunetuzumab-axgb) to treat adults with relapsed or refractory follicular lymphoma after receiving two or more lines of systemic therapy.

In particular, Lunsumio is a CD20xCD3 T-cell engaging bispecific antibody and a new class of fixed-duration cancer immunotherapy, according to a press release from Genentech, the manufacturer of the drug.

“This approval is a significant milestone for people with relapsed or refractory follicular lymphoma, who have had limited treatment options until now,” said Dr. Elizabeth Budde, a hematologic oncologist and associate professor in the division of lymphoma at City of Hope, in the release. “As a first-in-class T-cell engaging bispecific antibody that can be initiated in an outpatient setting, Lunsumio’s high response rates and fixed duration could change the way advanced follicular lymphoma is treated.”

This FDA approval was based on findings from the phase 2 GO29781 study, of which Budde was a clinical trial investigator. Researchers assessed Lunsumio in patients with follicular lymphoma who were heavily pretreated. This included patients who had a high risk for disease progression and those with refractory disease (does not respond to treatment).

Patients in the study had an objective response rate (the percentage of patients with a partial or complete response to treatment) of 80%, with most patients maintaining response to the treatment for at least 18 months, according to the release. Patients also had a median duration of response (the length of time a tumor continues to respond to treatment without cancer growth or spread) of 22.8 months. Complete responses (disappearance of all signs of cancer in the body) to the treatment were observed in 60% of patients.

The most common side effect related to Lunsumio was cytokine release syndrome, which lasted for a median of three days. Of note, cytokine release syndrome is a condition that may occur after treatment with some immunotherapies when cytokines are rapidly released into the blood, resulting in fever, nausea, rash, headache, low blood pressure, rapid heartbeat and trouble breathing.

Other side effects included rash, fatigue, fever and headache, according to the release.

“This additional treatment option is good news for people whose blood cancer has not responded to multiple lines of treatment because it can become more difficult to treat each time it returns,” said Dr. Lee Greenberger, chief scientific officer of the Leukemia & Lymphoma Society, in the release. “This bispecific antibody is an off-the-shelf, accessible treatment option that has the potential to help those with relapsed or refractory follicular lymphoma achieve remission.”

Lunsumio is administered intravenously for a fixed duration, allowing patients to have time off therapy, according to the release. In addition, the administration of Lunsumio can be done in an outpatient setting.

The company noted in the release that Lunsumio will be available for use in the U.S. in the coming weeks.

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