Lunsumio Combinations Deliver High Response Rates in Follicular and Large B-Cell Lymphomas

New clinical data presented at the 67th ASH Annual Meeting indicated that Lunsumio could be a strong candidate for earlier use in lymphoma care. Lunsumio plus lenalidomide achieved an 87% complete response rate in relapsed or refractory follicular lymphoma, while subcutaneous Lunsumio plus Polivy improved response rates and PFS in large B-cell lymphoma. Long-term follow-up also demonstrated durable remissions in follicular lymphoma.

Genentech has released new clinical data indicating that Lunsumio® (mosunetuzumab-axgb) may have an expanded role in earlier treatment settings for both follicular lymphoma and large B-cell lymphoma. The findings, presented at the 67th American Society of Hematology Annual Meeting, support the potential of outpatient, chemotherapy-free regimens that aim to provide deep and durable responses while reducing treatment complexity.

Lunsumio plus lenalidomide shows encouraging activity in FL

The single-arm extension of the Phase III CELESTIMO study delivered the first look at Lunsumio combined with lenalidomide in relapsed or refractory follicular lymphoma. Among 54 patients treated in the second line and beyond, the complete response rate reached 87.0 percent, confidence interval 75.1 to 94.6.

Cytokine release syndrome occurred in 27.8% of patients, mostly Grade 1. All events resolved. Neutropenia was reported in 40.7% and infections in 57.4%. The combination’s high activity suggests potential value earlier in the disease course. The primary analysis of the full CELESTIMO trial is expected in 2026.

Subcutaneous Lunsumio plus Polivy

Updated results from the Phase Ib/II GO40516 study reinforce the potential of a chemotherapy-free, outpatient regimen for relapsed or refractory large B-cell lymphoma. Treatment with subcutaneous Lunsumio plus Polivy produced an overall response rate of 77.5%, compared with 50% for rituximab plus Polivy. Median progression-free survival reached 25.4 months versus 6.4 months in the comparator arm. Safety findings were consistent with known profiles, including neutropenia, infections, febrile neutropenia and peripheral neuropathy.

Patient-reported outcomes from the Phase III SUNMO study, which evaluates the same combination, suggest improvements in several aspects of health-related quality of life. Patients reported better physical functioning as well as more favorable fatigue, symptom control and neuropathy scores than those receiving rituximab with gemcitabine and oxaliplatin.

“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,” said Levi Garraway, M.D., CMO and Head of Global Product Development. “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.”

Long-term data confirm durable responses in FL

Five-year follow-up results from the pivotal Phase II GO29781 study offer the longest available dataset for a CD20xCD3 bispecific in relapsed or refractory follicular lymphoma. Treatment with intravenous Lunsumio produced a five-year overall survival rate of 78.5%, confidence interval 69.6 to 87.4, and a 54-month duration of complete response rate of 52%. Three-year follow-up with the subcutaneous formulation showed an overall response rate of 74.5%, a complete response rate of 62.8% and a 30-month duration of complete response rate of 53.0 percent. No new safety signals were identified.

Expanding options through bispecific antibody innovation

Lunsumio monotherapy is approved in more than 60 countries for patients with follicular lymphoma who have received at least two prior systemic therapies. The European Commission recently approved the subcutaneous formulation, and a U.S. regulatory decision is expected soon. The program sits alongside Genentech’s broader bispecific portfolio, including Columvi®, with clinical efforts focused on new combinations and dosing strategies that aim to match the needs of varied patient populations and care settings.