Roche Lunsumio subcutaneous secures European Commission approval for refractory follicular lymphoma
Basel: Roche has announced that the European Commission has granted conditional marketing authorisation of Lunsumio (mosunetuzumab) subcutaneous (SC) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy.
Approval is based on results from the phase I/II GO29781 study, which showed that Lunsumio SC had pharmacokinetic non-inferiority compared with intravenous (IV) administration, with no unexpected safety signals.
“Building on the benefits of its fixed-duration dosing schedule, Lunsumio can now be administered with a one-minute subcutaneous injection, providing people with relapsed or refractory follicular lymphoma an additional treatment option to help meet their individual clinical requirements and lifestyle preferences,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “Developing new formulations of our medicines is part of our commitment to offering greater flexibility and a better treatment experience for patients.”
Lunsumio SC is a fixed-duration treatment that can be initiated in the outpatient setting and has the potential to substantially reduce treatment administration time with an approximately one-minute injection, compared with a 2-4 hour IV infusion.
Lunsumio has shown a favourable benefit-risk profile and high rates of deep and durable remissions with both IV and SC administration routes in third-line or later (3L+) FL. Lunsumio IV was the first bispecific antibody approved for 3L+ FL and has shown sustained responses, with 57% of patients who achieved a CR still in remission at five years. Long-term data from the SC and IV arms of the GO29781 study will be presented at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition.
These data have been submitted to other healthcare authorities around the world, including the US Food and Drug Administration.
Phase III studies involving Lunsumio SC are ongoing, including the MorningLyte trial investigating Lunsumio SC in combination with lenalidomide in previously untreated FL. Lunsumio, along with Columvi (glofitamab), is part of Roche’s industry-leading CD20xCD3 bispecific antibody portfolio.
