BASEL, Switzerland, June 18, 2026
Roche announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for Lunsumio VELO™ (subcutaneous mosunetuzumab) in combination with Polivy® (polatuzumab vedotin) for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL), following at least one prior systemic therapy. The FDA has assigned a target action date of February 9, 2027. The regulatory filing is supported by positive results from the Phase III SUNMO clinical trial, which demonstrated that the investigational chemotherapy-free combination significantly improved outcomes compared with the current standard regimen of rituximab, gemcitabine, and oxaliplatin (R-GemOx). If approved, the regimen could expand treatment access by providing an outpatient-ready therapy that can be administered in community oncology settings where the majority of U.S. lymphoma patients receive care.
Phase III SUNMO Trial Demonstrates Significant Clinical Benefit
The FDA submission is based on findings from the global Phase III SUNMO study, where Lunsumio VELO plus Polivy reduced the risk of disease progression or death by 59% compared with R-GemOx, achieving a hazard ratio of 0.41. The investigational combination also delivered a median progression-free survival (PFS) of 11.5 months, nearly three times longer than the 3.8 months observed with the comparator regimen. Importantly, the combination maintained a manageable safety profile consistent with the known characteristics of both medicines. Cytokine release syndrome (CRS) occurred in approximately one-quarter of treated patients, while Grade 2 or Grade 3 CRS events remained below 5%, supporting the feasibility of outpatient administration. Updated long-term results presented at both the American Society of Clinical Oncology (ASCO) Annual Meeting and the European Hematology Association (EHA) Congress continued to demonstrate durable progression-free survival benefits without introducing new safety concerns.
Potential Outpatient Treatment Could Address Major Unmet Need
Relapsed or refractory large B-cell lymphoma remains one of the most aggressive forms of non-Hodgkin lymphoma, with nearly 40% of patients experiencing relapse or treatment resistance after first-line therapy. Treatment delays caused by referral requirements, hospitalization, or limited access to specialized transplant centers can negatively impact patient outcomes. Roche believes the subcutaneous Lunsumio VELO plus Polivy regimen could help overcome these barriers by offering a chemotherapy-free, outpatient-based treatment option suitable for administration in local community oncology clinics. Lunsumio, a CD20xCD3 bispecific antibody, redirects a patient’s own T cells to eliminate malignant B cells, while Polivy, a CD79b-directed antibody-drug conjugate (ADC), selectively delivers chemotherapy directly into lymphoma cells. Together, the complementary mechanisms are designed to improve efficacy while simplifying treatment delivery for patients who may not have access to specialized academic centers.
Advertisement
Roche Continues Expanding Its Hematology Pipeline
The FDA filing further strengthens Roche’s leadership in hematology and oncology innovation, building on its extensive portfolio of approved therapies including Lunsumio, Polivy, Columvi, Gazyva, Hemlibra, and Venclexta. The company continues to expand clinical development of Lunsumio across multiple lymphoma settings through pivotal studies such as CELESTIMO and MorningLyte, evaluating the therapy in earlier treatment lines and novel combinations. The latest regulatory milestone also highlights Roche’s strategy of developing bispecific antibodies and antibody-drug conjugates that provide highly targeted treatment while improving patient convenience and access. If approved, the Lunsumio VELO plus Polivy combination could establish a new chemotherapy-free standard of care for eligible patients with relapsed or refractory large B-cell lymphoma, further advancing Roche’s mission to deliver innovative cancer therapies that improve long-term clinical outcomes and quality of life.
Source: Roche press release
