FDA approves Roche ’s Lunsumio, a first-in-class bispecific antibody, to treat people with relapsed or refractory follicular lymphoma

The objective response rate is the combination of complete response (CR) rate (a disappearance of all signs and symptoms of cancer) and partial response rate (a decrease in the amount of cancer in the body). The median duration of response among those who responded was almost two years (22.8 months [95% CI: 10-not reached]). A CR was achieved in 60% of patients (54/90 [95% CI: 49-70]). Among 218 patients with haematologic malignancies who received Lunsumio at the recommended dose, the most common adverse event (AE) was cytokine release syndrome (CRS; 39%), which can be severe and life-threatening. The median duration of CRS events was three days (range: 1-29). Other common AEs ( ≥20%) included fatigue, rash, pyrexia and headache.Lunsumio is administered as an intravenous infusion for a fixed-duration, which allows for time off therapy, and can be infused in an outpatient setting. Hospitalisation may be needed to manage select AEs, should be considered for subsequent infusions following a Grade 2 CRS event, and is recommended for subsequent infusions following a Grade 3 CRS event.Lunsumio was developed based on the Roche Group ' s broad expertise in creating bispecific antibodies. Lunsumio is designed to address the diverse needs of people with blood cancer, physicians, and practice settings, and is part of the company ’s robust bispecific antibody clinical programme in lymphoma. Lunsumio is being further investigated as a subcutaneous formulation (i.e., administered under...
Source: Roche Investor Update - Category: Pharmaceuticals Source Type: news