At the 2026 European Hematological Association (EHA) conference, held in Stockholm on 11–14 June, AstraZeneca shared preliminary safety data from its Phase III trial SOUNDTRACK-F1 (NCT06549595). This explores its pipeline agent surovatamig, a novel monoclonal CD19xCD3 bispecific T-cell engager (BiTCE), in patients with untreated advanced follicular lymphoma (FL).
FL is the second most common non-Hodgkin lymphoma, with approximately 100,000 new cases annually. Due to its relatively high rate of long-term survival, patients were historically monitored rather than treated, as chemotherapy-induced toxicity is seen to outweigh the benefits of treatment. However, advanced FL carries a significant risk of transformation into aggressive lymphoma. CD20-targeting monoclonal antibodies—principally Roche’s Rituxan (rituximab) and Gazyva (obinutuzumab)—in combination with chemotherapy have since become the standard of care after demonstrating their ability to significantly improve outcomes. However, over 25% of patients still experience progression after three years, and chemotherapy-related risks persist, especially for elderly patients. SOUNDTRACK-F1 aims to improve on this, establishing a chemotherapy-free regimen for untreated patients with scope to become the new standard of care.
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At EHA, safety data from the two dose-finding cohorts, named DL1 (2.4mg surovatamig plus 375mg/m2 rituximab, N=22) and DL2 (7.2mg surovatamig plus 375mg/m2 rituximab, N=21), were presented. All patients experienced treatment-emergent adverse events (TEAEs), mainly neutropenia (36–38%), fatigue (36–38%), and myalgia (36–38%), and TEAEs grade ≥3 were observed in 38.1–40.9% patients. Cytokine release syndrome (CRS), common for TCEs, was observed in 36–38% of patients, with one patient in the DL2 cohort experiencing CRS grade 2. Overall, these were clinically manageable, and there were no TEAEs leading to discontinuation. Preliminary efficacy data was also promising: overall response rates (ORRs) were 96%/100%, and in cohort DL2, with a median time on treatment of 7.9 months, progression-free survival was held at 100%. The DL2 dose will be used in the next arm of the study that will compare surovatamig plus rituximab directly against the standard of care, rituximab plus chemotherapy, in large-scale cohorts. AstraZeneca is not the only major player seeking to provide a chemotherapy-free treatment option in first line therapy. Roche is trialing a subcutaneous formulation of its CD20xCD3 BiTCE, Lunsumio (mosunetuzumab), in combination with the oral immunomodulatory drug lenalidomide in a Phase III trial named Morninglyte (NCT06284122). An earlier Phase I/II study in the same patient group found that Lunsumio with lenalidomide could achieve similarly high efficacy scores, with an ORR of 90%, though with a slightly worse safety profile—14% patients experienced TEAEs leading to discontinuation. Currently, Roche’s Lunsumio has two key advantages: this regimen would open up the possibility for outpatient care (surovatamig + rituximab requires a sizable clinical presence), and Lunsumio is already approved in the relapse/refractory setting, which may support clinical uptake over the unfamiliar surovatamig. AstraZeneca will need to demonstrate that surovatamig’s impressive lead on safety and efficacy is durable on long-term follow-up for it to have a chance of surpassing Roche in the front-line setting.
AstraZeneca acquired surovatamig as part of the company’s $1.2bn acquisition of TeneoTwo in 2022, and is keen to find an eligible position for its investment, exploring surovatamig in relapsed/refractory FL (SOUNDTRACK-B), diffuse large B-cell lymphoma (SOUNDTRACK-D2), and leukaemia (SOUNDTRACK-C1). If AstraZeneca is successful, current projections forecast 2032 annual global sales of surovatamig at $261m. Whether this takes directly from Lunsumio’s market share, projected to be $826m in global sales in 2032, will depend heavily on the outcome of these trials. Given that both started in 2024 within two months of each other, the outcome of this contest will be as exciting to follow in the next few years as it is significant to patients.
