Roche presented new and updated data at the 66th American Society of Hematology (ASH) Annual Meeting & Exposition showcasing the benefits of its fixed-duration bispecific antibodies, Columvi (glofitamab) and Lunsumio (mosunetuzumab), in treating aggressive and indolent lymphomas. The data highlight durable remissions, reduced treatment burden, and the potential of subcutaneous administration to improve patient experience.
Durable Remissions with Fixed-Duration Therapies
Three-year follow-up data from the pivotal phase II NP30179 study of Columvi in relapsed or refractory (R/R) large B-cell lymphoma (LBCL) showed that 40.0% of patients achieved a complete response (CR), with a median duration of CR of 29.8 months (95% CI: 22.0–NE). The majority of patients in complete remission at the end of therapy remained in remission two years after therapy completion. The safety profile was consistent with previous analyses.
Long-term data at four years from the pivotal phase II GO29781 study of Lunsumio in patients with R/R follicular lymphoma (FL) demonstrated long-lasting remissions, with nearly two-thirds (64.0% [95% CI: 50.1-78.0]) of patients with a CR alive and without disease progression at 45 months. The overall response rate (ORR) and CR rates in the overall population were 77.8% and 60.0%, respectively. Consistent results were observed in patients with a history of disease progression within 24 months of frontline treatment (POD24). No new safety signals were observed.
Both studies indicated restoration of B-cell levels, starting from 12-18 months following Columvi treatment and after a median of 19 months following Lunsumio treatment, suggesting immune system recovery and supporting the use of a fixed-duration treatment approach.
Subcutaneous Lunsumio Shows Promise
Data from a primary analysis of the phase II GO29781 study of subcutaneous Lunsumio in patients with third-line or later FL showed pharmacokinetic non-inferiority compared to intravenous (IV) administration. The fixed-duration subcutaneous Lunsumio achieved high rates of deep and durable remissions, with 76.6% of patients experiencing an ORR and a 61.7% CR rate, as evaluated by the independent review committee. The median progression-free survival was 23.7 months (95% CI: 14.6-NE), while the median overall survival was not reached. The most common all-grade adverse events (AEs) were injection-site reactions (60.6%; all Grade 1-2), fatigue (35.1%), and cytokine release syndrome (CRS; 29.8%). The rate and severity of CRS events were low (Grade 1-2, 27.6%; Grade 3, 2.1%); all occurred during cycle 1 and were resolved.
Columvi and Polivy Combination Shows Efficacy
Updated data from the phase I/Ib investigational NP39488 study showed high and durable response rates in people with R/R LBCL treated with Columvi in combination with Polivy, including those with high-grade disease and prior treatment with CAR T-cell therapy. Of the 128 efficacy-evaluable patients, the best ORR was 80.6%, with a CR rate of 62.0%, and the median duration of CR was 31.8 months (95% CI: 21.9-NE). Among patients previously treated with CAR T-cell therapy (n=28), the ORR was 75.0%, with a CR rate of 50.0%. The safety profile was manageable and consistent with the known profiles of the individual drugs. The most common AE was CRS (44.4%), which was mostly Grade 1-2.
Impact on Treatment Burden
A US real-world data study and economic model highlighted the impact of treatment-related travel burden on patients with R/R non-Hodgkin lymphoma. The study found that fixed-duration therapies, such as Columvi and Lunsumio, reduce treatment-related travel burden due to less frequent dosing, emphasizing the importance of patient-centered treatment options.
"The data being presented at ASH offer further evidence that Columvi and Lunsumio can provide lasting remissions for people with advanced lymphoma," said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. "The results underscore our ambition to transform the treatment of B-cell malignancies with a range of innovative therapeutic options."
