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SYRUS phase I/II trial: Safety and efficacy of surovatamig (AZD0486) in patients with R/R B-ALL
Surovatamig (AZD0486) is a novel CD19xCD3 bispecific T-cell engager with low-affinity CD3 binding to reduce cytokine release from T-cell activation while preserving T-cell cytotoxicity in malignant B-cells. A first-in-human phase I trial (NCT04594642) has demonstrated clinical activity and tolerability of surovatamig in relapsed/refractory (R/R) B-cell lymphomas.1 During the European Hematology Association (EHA) 2025 Congress, Ibrahim Aldoss presented preliminary results from the phase I/II SYRUS trial (NCT06137118) evaluating the safety and efficacy of surovatamig in patients with R/R B-cell acute lymphoblastic leukemia (B-ALL).2 Eligible patients include adolescents and adults diagnosed with CD19+ R/R B-ALL who have received either ≥2 prior therapies or ≥1 prior therapy if no other standard of care option is available. In the dose-escalation phase, to minimize adverse events, patients received triple step-up dosing (SUD) of surovatamig to reach target doses of 2.5 mg (dose level [DL] 1), 7.2 mg (DL2) and 15 mg (DL3). The primary endpoint was safety and tolerability.
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Key learnings |
The most common Grade 3 non-hematologic TEAEs (N=31) included infection (19%), febrile neutropenia (19%), and increased ALT/AST (6%). Grade 4 hematologic TEAEs included neutropenia (23%), lymphopenia (13%), and thrombocytopenia (16%). |
Two patients experienced DLT with prolonged cytopenia but were able to reach the TD without reoccurrence of cytopenia. AEs leading to treatment discontinuation were reported in 13% of patients and were deemed not treatment related. |
Grade 3 CRS was reported in 1 patient and occurred during SUD2 (n = 18); there was also only 1 case of Grade 3 ICANS, reported for DL3 (after TD 7.2 mg, n=12). |
At DL1, DL2, and DL3, the ORRs were 46%, 58%, and 83%, respectively; while ORRs in patients with EMD were 67% and 100% at DL1 and DL2, respectively. A 6-month DOR was achieved by 86.5% of patients. |
Surovatamig (AZD0486) was well-tolerated and demonstrated encouraging response rates in patients with R/R B-ALL. The study continues to enroll patients into the dose optimization and expansion phase. |
AE, adverse event; ALT, alanine aminotransferase; AST, aspartate aminotransferase; B-ALL, B-cell acute lymphoblastic leukemia; CRS, cytokine release syndrome; DL, dose level; DLT, dose-limiting toxicity; DOR, duration of response; EMD, extramedullary disease; ICANS, immune effector cell-associated neurotoxicity syndrome; ORR, overall response rate; R/R, relapsed/refractory; SUD, step-up dosing; TEAE, treatment-emergent adverse event.
References
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