Late last week, big pharma company Roche announced FDA approval of its bi-specific antibody Lunsumio for the treatment of people with a relapsed or refractory form of non-Hodgkin lymphoma, follicular lymphoma (FL). The regulatory nod comes under an accelerated approval based on a Phase II pivotal study that showed an 80% durable response rate in patients who had received at least two prior therapies for treatment of the disease, with 60% of patients exhibiting complete remission. Continued approval for the drug for this indication will be contingent on a confirmatory trial to confirm the clinical benefit of the therapy.
According to Roche, Lunsumio (mosunetuzumab) is a CD20xCD3 T-cell engaging bispecific antibody that is a new class of fixed-duration immunotherapies. It is administered as an intravenous infusion for a fixed duration and can be infused in an outpatient setting. The company expects the drug to be available in the U.S. in the coming weeks.
“This approval is a significant milestone for people with relapsed or refractory follicular lymphoma, who have had limited treatment options until now,” said clinical trial investigator Elizabeth Budde, MD, PhD, Haematologic Oncologist and associate professor, City of Hope Division of Lymphoma, Department of Hematology & Hematopoietic Cell Transplantation. “As a first-in-class T-cell engaging bispecific antibody that can be initiated in an outpatient setting, Lunsumio’s high response rates and fixed-duration could change the way advanced follicular lymphoma is treated.”
For the approval, the FDA used the results of the multicenter, open-label, dose-escalation and expansion Phase II GO29781 study evaluating the safety, efficacy and pharmacokinetics of Lunsumio. Enrolled patients had relapsed or refractory B-cell non-Hodgkin lymphoma who had heavily pre-treated FL, including those who were at high risk of disease progression or whose disease was refractory to prior therapies. An objective response was seen in 80% of patients treated with Lunsumio, with 57% maintaining their for at least 18 months. Objective response rate is the combination of complete response (CR) rate, exhibited by a disappearance of all signs and symptoms of cancer, with partial response rate defined as a decrease in the amount of cancer in the body.
Median duration among those who responded was almost two years (22.8 months) and CR was achieved in 54 of 90 patients, a response rate of 60%. Among 218 patients with hematologic malignancies who received Lunsumio at the recommended dose, the most common adverse event (AE) was cytokine release syndrome (39%), which can be severe and life-threatening. The median duration of these events was three days and ranged from one to 29 days. Other common AEs included fatigue, rash, pyrexia and headache.
Other ongoing studies of the drug include its use as a subcutaneous formulation and in Phase III studies designed to broaden the understanding of its impact in earlier lines of treatment in people with non-Hodgkin lymphoma.
“Despite treatment advances, follicular lymphoma remains incurable and relapse is common, with outcomes worsening following each consecutive treatment,” said Levi Garraway, MD, PhD, Roche’s CMO and head of Global Product Development. “Lunsumio represents our first approved T-cell engaging bispecific antibody and builds on our legacy of more than 20 years of innovation in blood cancer.”
