Roche presented new and updated findings from its pioneering CD20xCD3 T-cell-engaging bispecific antibody program at the 66th American Society of Hematology (ASH) Annual Meeting, held from December 7-10, 2024. With over 20 abstracts accepted, the data emphasize the potential of fixed-duration therapies, Columvi® (glofitamab) and Lunsumio® (mosunetuzumab), in addressing both aggressive and indolent lymphomas. These insights underline Roche’s commitment to advancing lymphoma treatment by improving patient outcomes and experiences.
Promising Long-Term Results for Fixed-Duration Therapies
Follow-up results from the pivotal phase II NP30179 trial for Columvi in relapsed or refractory large B-cell lymphoma (R/R LBCL) demonstrated a complete response (CR) in 40.0% of patients, with a median duration of CR of 29.8 months. Most patients who achieved remission remained disease-free two years after therapy completion, and the safety profile was consistent with prior analyses.
Similarly, the phase II GO29781 study for Lunsumio in relapsed or refractory follicular lymphoma (R/R FL) showed enduring efficacy. After four years of follow-up, 64.0% of patients with CR were progression-free at 45 months. The overall response rate (ORR) and CR rates in the entire cohort were 77.8% and 60.0%, respectively. Notably, even patients with progression within 24 months of frontline treatment (POD24)—a challenging subgroup—responded well. Safety signals remained consistent with prior observations.
Both therapies showed recovery of B-cell levels 12-19 months after treatment, highlighting immune system restoration. This supports the fixed-duration treatment approach, enabling patients to regain immune functionality post-therapy.
Subcutaneous Lunsumio: A Patient-Centric Innovation
Roche presented findings on a subcutaneous formulation of Lunsumio for R/R FL, which demonstrated pharmacokinetic non-inferiority to intravenous (IV) administration. In the phase II GO29781 study, subcutaneous Lunsumio achieved a 76.6% ORR and a 61.7% CR rate. The median progression-free survival was 23.7 months, while the median overall survival was not reached.
The subcutaneous route also offered benefits such as shorter administration times and fewer side effects, primarily mild injection-site reactions and low-grade cytokine release syndrome (CRS). These findings support ongoing submissions to health authorities, offering patients a more convenient alternative without compromising efficacy.
Enhancing Efficacy with Combination Therapies
Data from a randomized phase II cohort of the GO40516 study demonstrated the efficacy of subcutaneous Lunsumio in combination with Polivy® (polatuzumab vedotin) for R/R LBCL. This combination achieved an ORR of 77.5% compared to 50.0% with MabThera®/Rituxan® (rituximab) and Polivy. CR rates were also higher in the Lunsumio arm at 57.5% versus 35.0%.
The safety profile was favorable, with injection-site reactions and neutropenia being the most common side effects. CRS events were rare, mild, and resolved during the first cycle. These findings pave the way for further research in the ongoing phase III SUNMO study, which is exploring this combination as a second-line treatment option for diffuse large B-cell lymphoma (DLBCL).
Expanding Treatment Options in Earlier-Stage LBCL
Updated results from the phase I/Ib NP39488 study assessed Columvi combined with Polivy in patients with R/R LBCL, including those previously treated with CAR T-cell therapy. Among 128 evaluable patients, the ORR was 80.6%, with a CR rate of 62.0%. For patients previously treated with CAR T-cell therapy, the ORR and CR rates were 75.0% and 50.0%, respectively.
The median duration of CR was 31.8 months, and the safety profile was consistent with known drug characteristics. CRS was the most common adverse event but was generally low-grade and manageable. These findings support further investigation in the phase III SKYGLO study, which is evaluating this combination as part of a frontline regimen for DLBCL.
Reducing Patient Burden with Fixed-Duration Therapies
A real-world study highlighted the significant impact of fixed-duration therapies like Columvi and Lunsumio on reducing travel and logistical burdens for patients with R/R non-Hodgkin lymphoma. By requiring fewer treatment appointments, these therapies ease travel-related costs and time commitments, addressing a critical aspect of the patient experience beyond clinical outcomes.
Commitment to Transforming Lymphoma Care
Dr. Levi Garraway, Roche’s Chief Medical Officer, emphasized, “The data presented at ASH reinforce our ambition to redefine treatment for B-cell malignancies with innovative therapies that improve outcomes and quality of life for patients.”
These findings, combined with the promising results from subcutaneous administration and combination studies, position Roche at the forefront of advancing lymphoma care. Through continued innovation, the company aims to set new standards in managing both aggressive and indolent lymphomas, enhancing treatment options for patients worldwide.
