European Commission Approves Roche’s Lunsumio Subcutaneous For Adults With Relapsed Or Refractory Follicular Lymphoma After Two Or More Prior Therapies

Roche has announced that the European Commission has granted conditional marketing authorisation for Lunsumio (mosunetuzumab) administered subcutaneously for the treatment of adult patients with relapsed or refractory follicular lymphoma who have received two or more prior lines of systemic therapy. This approval is based on results from the Phase I/II GO29781 study, which demonstrated that the subcutaneous formulation of Lunsumio achieves pharmacokinetic non-inferiority compared with intravenous administration and does not present any unexpected safety concerns.

According to Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development, the fixed-duration dosing schedule of Lunsumio allows it to be administered as a one-minute subcutaneous injection, offering patients an additional treatment option that can align with their individual clinical needs and lifestyle preferences. The development of new formulations is part of Roche’s commitment to providing patients with greater flexibility and an improved treatment experience.

The subcutaneous version of Lunsumio is a fixed-duration therapy that can be initiated in an outpatient setting. Compared with intravenous administration, which typically takes two to four hours, the subcutaneous injection significantly reduces the time required for treatment, making it more convenient for patients and healthcare providers.

Lunsumio has shown a favourable benefit-risk profile and high rates of deep and durable remissions in patients receiving third-line or later therapy for follicular lymphoma. The intravenous form of Lunsumio was the first bispecific antibody approved for this patient population and demonstrated sustained responses, with 57 percent of patients achieving complete remission still in remission after five years. Long-term data from both the subcutaneous and intravenous arms of the GO29781 study will be presented at the 67th American Society of Hematology Annual Meeting and Exposition.

Roche has submitted these data to other healthcare authorities globally, including the US Food and Drug Administration. Ongoing Phase III studies are evaluating Lunsumio subcutaneous in combination with other therapies, such as the MorningLyte trial, which investigates its use with lenalidomide in previously untreated patients with follicular lymphoma.

Lunsumio, together with Columvi (glofitamab), is part of Roche’s industry-leading portfolio of CD20xCD3 bispecific antibodies. The company continues to explore new formulations and combinations of these medicines across different disease areas and lines of treatment, reflecting its commitment to improving the patient experience and providing more options to meet the needs of patients and healthcare systems.