Roche's Lunsumio VELO Approved by FDA for Subcutaneous Use in Follicular Lymphoma

FDA Approval

The FDA has approved Lunsumio VELO, a CD20xCD3 bispecific antibody, for subcutaneous use in treating adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. This approval is based on the phase I/II GO29781 study results.

Study Results

The GO29781 study demonstrated a 75% objective response rate and a 59% complete response rate in patients treated with Lunsumio VELO. The median duration of response was 22.4 months. Common adverse reactions included injection site reactions, fatigue, rash, cytokine release syndrome (CRS), COVID-19 infection, musculoskeletal pain, and diarrhea. The CRS rate was 30%, with most events being low grade and resolving after a median of two days.

Administration and Treatment

Lunsumio VELO significantly reduces treatment administration time to approximately one minute compared to the 2-4 hour intravenous infusion. It is a fixed-duration treatment, potentially as short as six months, and can be administered in outpatient settings.

Future Developments

Roche is advancing its bispecific antibody program in lymphoma with ongoing phase III studies. These include the SUNMO study, investigating Lunsumio VELO in combination with Polivy in second-line or later large B-cell lymphoma, and the MorningLyte study, exploring its use with lenalidomide in previously untreated follicular lymphoma.