2022-06-09| Trials & Approvals

Europe Okays Roche’s CAR-T Competitor for Blood Cancer

by Fujie Tham
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Roche won a conditional approval from the European Commission for Lunsumio (mosunetuzumab) to treat relapsed/refractory follicular lymphoma patients who have received at least two prior therapies. The news makes Lunsumio the first CD20xCD3 bispecific antibody approved in the world.

“Lunsumio’s high response rates, off-the-shelf availability, and initial outpatient administration could transform how advanced follicular lymphoma is treated,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development.

Roche received FDA Breakthrough Therapy Designation for Lunsumio back in mid-2021 and submitted the drug to the FDA later in December.

Related article: Novartis CAR-T Cell Therapy Receives FDA Approval for Third Indication to Treat Follicular Lymphoma


First Bispecific Antibody Therapy for Follicular Lymphoma


Follicular lymphoma (FL) is the most common slow-growing form of non-Hodgkin lymphoma (NHL), accounting for approximately 1 in 5 cases of NHL, the disease develops when the body produces abnormal B-cells. The disease is considered incurable and relapse is common, over 100,000 people are diagnosed with FL each year globally.

Roche’s Lunsumio is a first-in-class CD20xCD3 T-cell targeting bispecific antibody designed to target CD20 on the surface of B-cells and CD3 on the surface of T-cells. Bispecific antibody means that the therapeutic can simultaneously bind to two different antigen types or two different epitopes on the same antigen. Lunsumio activates and recruits a patient’s existing T-cells to engage and eliminate abnormal B-cells by releasing cytotoxic proteins into the B-cells.

The approval comes after positive results from the Phase 1/2 GO29781 study where Lunsumio demonstrated high complete response rates after 18.3 months median follow-up, where the medicine eliminated signs of tumor in 60% of the patients. While 80% of patients show reduced tumor signatures.  

“Lunsumio is an off-the-shelf therapy that is readily available, so people do not have to wait to start treatment.” Roche is touting the Lunsumio’s high response rates and off-the-shelf availability in comparison with CAR-T therapies, which are complex and could take over two weeks to prepare a patient’s cells and return for infusion into the patient. Last month, the European Commission also approved Novartis’ Kymriah for the same indication.

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