Roche's Lunsumio-Based Regimen Shows Significant Improvement in Follicular Lymphoma Treatment

Roche has announced significant progress in its ongoing efforts to improve treatment outcomes for patients with follicular lymphoma (FL). The results of the phase III CELESTIMO study, evaluating the efficacy and safety of Lunsumio® (mosunetuzumab) in combination with lenalidomide, have shown a statistically significant and clinically meaningful reduction in the risk of disease progression in patients who have received at least one prior line of treatment.

The study, which met its primary endpoint at the interim analysis, demonstrated that the Lunsumio-based regimen offers a tolerable safety profile and a simple dosing schedule, making it an attractive option for outpatient administration. Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development, commented, "People living with relapsed or refractory follicular lymphoma need treatment options that provide meaningful clinical benefit and minimal disruptions to everyday care. The CELESTIMO results indicate that a two-drug outpatient Lunsumio regimen may offer these patients an effective new option earlier in their treatment journey."

Follicular lymphoma is the most common slow-growing form of non-Hodgkin lymphoma, accounting for about one in five cases worldwide. It typically responds well to treatment but often experiences periods of remission and relapse. Early progression can be associated with poor long-term prognosis. The disease is estimated to affect more than 110,000 people annually.

Lunsumio, a first-in-class CD20xCD3 T-cell engaging bispecific antibody, is already approved as a fixed-duration monotherapy for the treatment of adult patients with third-line or later relapsed or refractory follicular lymphoma (FL) in both intravenous and subcutaneous formulations. The CELESTIMO study is a confirmatory trial required to convert the accelerated approval/conditional marketing authorisation of Lunsumio monotherapy for third-line or later FL to full approval, as well as to secure an indication in second-line or later FL.

Garraway added, "The CELESTIMO results reinforce the potential of this Lunsumio-based regimen to improve clinical outcomes, while offering a tolerable safety profile, simple dosing schedule, and outpatient administration. Data from the study will be submitted to health authorities and presented at an upcoming medical meeting."

Roche's commitment to advancing treatment options for B-cell malignancies is evident in its robust, global development programme. Lunsumio is part of Roche’s industry-leading CD20xCD3 bispecific antibody programme, designed with the unique needs and preferences of patients in mind. The company is also exploring the clinical utility of Lunsumio earlier in the disease course and in novel combinations, including the phase III MorningLyte study ongoing in first-line FL.

The U.S. Food and Drug Administration (FDA) recently accepted the supplemental Biologics License Application (sBLA) for Lunsumio in combination with Polivy® (polatuzumab vedotin) for second-line or later (2L+) diffuse large B-cell lymphoma (DLBCL) based on the SUNMO study. The results from the CELESTIMO study support continued expansion of Lunsumio and lenalidomide into earlier FL treatment.

Roche has been developing medicines for people with malignant and non-malignant blood diseases for more than 25 years. Today, the company is investing more than ever in its effort to bring innovative treatment options to patients across a wide range of haematologic diseases.