FDA Green Lights 'One-Minute' Injection for R/R Follicular Lymphoma Treatment

The U.S. Food and Drug Administration (FDA) has granted accelerated approval to the CD20xCD3 bispecific antibody Lunsumio VELO (mosunetuzumab), as a subcutaneous formulation, for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy, based on results from the phase 1/2 GO29781 study, according to a news release from Roche.

In this study, 75% of patients had an objective response rate (saw their cancer shrink or respond to treatment), and 59% had a complete response (no detectable cancer after treatment). Among patients who responded, the benefit lasted a median of 22.4 months.

“Since follicular lymphoma often requires lifelong management, reducing the burden of care for these individuals is of paramount importance,” Dr. Levi Garraway, Roche’s chief medical officer and head of Global Product Development, said in the news release. “With this FDA approval, treatment can now be administered in just one minute, which significantly reduces the time patients spend in the clinic and helps to align care with their individual needs and preferences.”

Lunsumio VELO is designed to make treatment visits shorter by delivering therapy through an injection that takes about one minute, rather than an intravenous infusion that can last two to four hours. It can be given in an outpatient setting, similar to the intravenous (through the vein) form of Lunsumio. The subcutaneous treatment is provided for a set period of time, which in some cases may be as short as six months. This differs from other approaches that are continued long-term and only stopped if the cancer progresses or side effects become too hard to tolerate, according to the release.

“This approval is a significant step in broadening access to effective treatments for people living with follicular lymphoma,” Dr. Dr Ian Flinn, Tennessee Oncology and One Oncology, said in the news release. “With its manageable cytokine release syndrome profile and reduced administration time, Lunsumio VELO enables oncologists to deliver advanced care in community practice settings.”

The most common side effects which were reported in at least 20% of patients included reactions at the injection site, fatigue, skin rash, cytokine release syndrome, COVID-19 infection, muscle or joint pain, and diarrhea. Cytokine release syndrome occurred in 30% of patients, but most cases were mild to moderate. These events typically happened during the first treatment cycle and resolved within a median of two days. While most cases were manageable, cytokine release syndrome can be serious and, in rare cases, life-threatening.

Intravenous Lunsumio was the first bispecific antibody approved for patients with follicular lymphoma who had already received three or more prior lines of treatment. Updated, longer-term results from both the injection and intravenous groups in the GO29781 study were later shared at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition.

Breaking Down the Basics of Lunsumio VELO

Lunsumio VELO is a subcutaneous form of IV Lunsumio that is designed to help the immune system target cancerous B cells. It works by connecting two types of cells in the body: B cells, which carry a marker called CD20, and T cells, which have a marker called CD3. By bringing these cells together, the treatment activates a patient’s own T cells so they can recognize and destroy the cancerous B cells.

Lunsumio VELO is being studied both on its own and alongside other treatments for people with B-cell non-Hodgkin lymphomas, including follicular lymphoma and large B-cell lymphoma, as well as other related diseases.

Study Details of GO29781

The GO29781 study is an early- to mid-stage clinical trial that tested Lunsumio VELO in people with relapsed or refractory B-cell non-Hodgkin lymphoma. Researchers looked at the treatment when given both through a vein (IV) and as an injection under the skin (subcutaneously), focusing on how safe it was, how well it worked and how the drug moved through the body. The treatment’s benefit was measured by how many patients responded and how long those responses lasted.

Reference

1. “FDA approves Roche’s Lunsumio VELO™ for subcutaneous use in relapsed or refractory follicular lymphoma.” News Release. Roche.

For more news on cancer updates, research and education, don’t forget to subscribe to CURE®’s newsletters here.