Lunsumio VELO reduces administration time from 2-4 hours to approximately one minute
Genentech, part of the Roche Group, announced that the U.S. Food and Drug Administration has approved Lunsumio VELO, a subcutaneous formulation of the CD20xCD3 bispecific antibody mosunetuzumab-axgb, for adult patients with relapsed or refractory follicular lymphoma who have received at least two prior systemic therapies. The approval is based on findings from the Phase I/II GO29781 study and is granted under accelerated approval, with full approval contingent on results from a confirmatory trial.
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Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development at Genentech, emphasized that follicular lymphoma often requires long-term care, making it essential to reduce treatment burden. He highlighted that Lunsumio VELO can now be administered in approximately one minute, significantly reducing time spent in clinics while aligning care with patient preferences.
Lunsumio VELO offers a faster alternative to the intravenous version, which takes 2 to 4 hours per infusion, while maintaining the ability to be delivered in an outpatient setting. Both forms of Lunsumio are fixed-duration treatments, which may last as little as six months, unlike treat-to-progression therapies that continue until disease progression or intolerance.
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Dr. Ian Flinn of Tennessee Oncology and One Oncology noted that this approval expands access to effective treatment for people living with follicular lymphoma. He explained that the manageable cytokine release syndrome profile and reduced administration time make Lunsumio VELO suitable for community practice settings.
The FDA decision was supported by the primary analysis of the GO29781 study, which showed an objective response rate of 75 percent and a complete response rate of 59 percent in patients treated with Lunsumio VELO. The median duration of response was 22.4 months. The most common adverse effects reported in at least 20 percent of patients included injection site reactions, fatigue, rash, cytokine release syndrome, COVID-19 infection, musculoskeletal pain, and diarrhea. Most cytokine release syndrome events were low grade, occurring primarily in the first cycle, and resolved within a median of two days. Severe events were rare but possible.
Lunsumio intravenous was the first bispecific antibody approved for third-line or later follicular lymphoma. Long-term data from both the intravenous and subcutaneous arms of the GO29781 study were presented at the 67th American Society of Hematology Annual Meeting and Exposition. These findings have been submitted to other global health authorities, and the European Commission recently granted conditional marketing authorization for Lunsumio SC in adults with relapsed or refractory follicular lymphoma after at least two prior systemic treatments.
Genentech continues to advance its bispecific antibody program in lymphoma with ongoing Phase III trials evaluating Lunsumio and Lunsumio VELO in earlier lines of treatment. This includes the SUNMO study assessing Lunsumio VELO with Polivy in second-line or later large B-cell lymphoma, and the MorningLyte study evaluating Lunsumio VELO with lenalidomide in previously untreated follicular lymphoma.
Genentech remains committed to helping patients access prescribed medications and plans to offer patient assistance programs through Genentech Access Solutions for those who qualify.
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