Roche gets EC approval for Lunsumio to treat follicular lymphoma14 June 2022
The EC approval is based on positive results from the Phase ½ GO29781 study, which assessed the safety, efficacy and pharmacokinetics of Lunsumio in people with B-cell non-Hodgkin lymphoma
Roche has received the European Commission (EC) conditional marketing authorisation for Lunsumio (mosunetuzumab) to treat a type of follicular lymphoma (FL).
The drug is indicated for treating relapsed or refractory (R/R) FL in adults, who have received at least two prior systemic therapies.
Lunsumio is a CD20xCD3 T-cell engaging bispecific antibody, readily available as an off-the-shelf therapy to the people, preventing them from waiting to start the treatment.
The drug’s dual targeting mechanism activates and redirects the patient’s existing T-cells to engage and eliminate target B-cells by releasing cytotoxic proteins.
Roche chief medical officer and global product development head Levi Garraway said: “We are delighted that Lunsumio is the first bispecific antibody approved in Europe for people with relapsed or refractory follicular lymphoma.
“Lunsumio’s high response rates, off-the-shelf availability, and initial outpatient administration could transform how advanced follicular lymphoma is treated.”
The EC approval is supported by positive results from the Phase ½ GO29781 study, which assessed the safety, efficacy and pharmacokinetics of Lunsumio in people with B-cell non-Hodgkin lymphoma.
In the Phase ½ trial, Lunsumio showed a high complete response rate of 60%, an objective response rate of 80% and favourable tolerability in people with heavily pre-treated FL.
The complete response rate was the primary endpoint, and duration of response, progression-free survival, safety, and tolerability were the secondary endpoints.
The common adverse events include cytokine release syndrome, alongside neutropenia, pyrexia, hypophosphatemia and headache.
Roche is developing Lunsumio in two ongoing Phase 3 trials, CELESTIMO, and SUNMO, in FL, and diffuse large B-cell lymphoma (DLBCL) respectively.
City of Hope haematologic oncologist and associate professor Elizabeth Budde said: “Having additional treatment options for people with follicular lymphoma, where multiple prior lines of therapy have failed, is critical to help them achieve better outcomes.
“It is exciting to have a new class of immunotherapy like Lunsumio, offering a readily available, chemotherapy-free and fixed-duration treatment, with great potential to provide durable remissions without the need to stay on treatment continuously.”