Genentech Highlights Lunsumio’s Expanding Potential Across Multiple Lymphoma Treatment Lines at ASH 2025
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today presented compelling new clinical data at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition, held from December 6–9, 2025 in Orlando, Florida. The data highlighted the potential of Lunsumio® (mosunetuzumab-axgb), a CD20xCD3 bispecific antibody, across earlier lines of treatment for people living with various types of lymphoma.
These findings build on the clinical foundation established by Lunsumio in later-stage follicular lymphoma (FL) and suggest the medicine’s potential to significantly broaden therapeutic options in both indolent and aggressive lymphoma subtypes.
Expanding Lunsumio’s Role in Earlier Lines of Follicular Lymphoma
Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development at Genentech, emphasized the broader implications of these findings. “These data underscore the potential of Lunsumio to support more people living with lymphoma, building on the clinical benefit observed in later-stage follicular lymphoma,” Dr. Garraway said. “Moreover, the combinatorial potential of Lunsumio is evident in the two-drug regimens presented, which may enable outpatient treatment while preserving deep and durable efficacy.”
Preliminary findings from the single-arm extension of the pivotal Phase III CELESTIMO study evaluated the combination of Lunsumio with lenalidomide in patients with relapsed or refractory (R/R) follicular lymphoma (FL), focusing on those in second-line or later (2L+) therapy. The study included 54 participants, demonstrating promising efficacy for this two-drug regimen.
- Complete Response (CR) Rate: 87.0% (95% confidence interval [CI]: 75.1–94.6)
- Cytokine Release Syndrome (CRS): 27.8% of patients experienced CRS, with the majority being low grade (Grade 1: 22.2%; Grade 2: 3.7%; Grade 3: 1.9%), and all events were resolved.
- Neutropenia: Observed in 40.7% of patients
- Infections: Reported in 57.4% of patients
These data suggest that the combination of Lunsumio and lenalidomide could offer meaningful clinical benefits earlier in the disease course. The primary analysis of the pivotal Phase III CELESTIMO study is expected in 2026, which will further clarify the potential of this regimen for broader patient populations.
Lunsumio Plus Polivy® Shows Promise in Aggressive Large B-Cell Lymphoma
In addition to follicular lymphoma, Genentech presented long-term follow-up data from the Phase Ib/II GO40516 study evaluating subcutaneous (SC) Lunsumio in combination with Polivy® (polatuzumab vedotin-piiq) for patients with relapsed or refractory large B-cell lymphoma (LBCL). The results suggest a clinically meaningful improvement compared to standard therapy with Rituxan® (rituximab) plus Polivy.
- Overall Response Rate (ORR): 77.5% (95% CI: 61.6–89.2) vs. 50.0% (95% CI: 33.8–66.2)
- Median Progression-Free Survival (PFS): 25.4 months (95% CI: 9.2–not evaluable) vs. 6.4 months (95% CI: 4.7–18.6)
Adverse events were consistent with previous studies, with no new safety signals identified:
- Neutropenia or decreased neutrophil count: 40%
- Febrile neutropenia: 2.5%
- Infections: 45%
- Peripheral neuropathy: 10%
Patient-reported outcomes from the Phase III SUNMO study, investigating the same combination, revealed benefits across multiple aspects of health-related quality of life measures, including physical functioning, fatigue, lymphoma symptoms, and peripheral neuropathy. This combination therapy has the potential to extend remission and improve outcomes for patients living with aggressive LBCL while minimizing the need for conventional chemotherapy, making outpatient administration a feasible option.
Sustained Responses with Lunsumio in Third-Line and Later Follicular Lymphoma
Genentech also shared five-year follow-up data from the pivotal Phase II GO29781 study, which represents the longest reported follow-up for a CD20xCD3 bispecific in R/R FL. Key findings include:
- Overall Survival Rate: 78.5% at five years (95% CI: 69.6–87.4)
- Duration of Complete Response (DOCR): 54 months in 52.0% of patients (95% CI: 36.1–67.9)
Additionally, three-year follow-up data for investigational SC Lunsumio showed durable responses in patients with R/R FL:
- ORR: 74.5%
- CR Rate: 62.8%
- 30-Month DOCR: 53.0% (95% CI: 38.7–67.4)
No new safety signals were observed, demonstrating consistent long-term tolerability for both intravenous (IV) and SC formulations.
Regulatory Approvals and Global Expansion
Lunsumio monotherapy is currently approved in over 60 countries for patients with FL who have received at least two prior systemic therapies. The SC formulation of Lunsumio was recently approved by the European Commission for FL after two or more lines of systemic therapy. A regulatory decision from the U.S. Food and Drug Administration is anticipated soon, further expanding access for patients worldwide.
About Lunsumio® (mosunetuzumab-axgb)
Lunsumio is a first-in-class CD20xCD3 T-cell-engaging bispecific antibody designed to target CD20 on the surface of B cells and CD3 on the surface of T cells. This dual-targeting activates and redirects a patient’s existing T cells to engage and eliminate target B cells by releasing cytotoxic proteins into the B cells. A robust clinical development program for Lunsumio is ongoing, investigating the molecule as a monotherapy and in combination with other medicines, for the treatment of people with B-cell non-Hodgkin lymphomas, including follicular lymphoma, diffuse large B-cell lymphoma, and other indications.
