AstraZeneca’s Surovatamig Delivers 100% PFS; Capivasertib Approved with 7.5-Month PFS Gain
AZN•EHA trial of surovatamig plus rituximab in untreated follicular lymphoma showed 100% ORR and 100% PFS at a 7.9-month median with 36–38% CRS and 38–41% grade ≥3 TEAEs but no discontinuations. FDA approved capivasertib plus abiraterone for PTEN-deficient metastatic prostate cancer with 19% risk reduction and 7.5-month PFS gain; Ultomiris earned Priority Review after 46.6% versus 5.6% proteinuria reduction.
1. SOUNDTRACK-F1 Phase III Safety and Efficacy
At the European Hematological Association meeting, surovatamig plus rituximab in dose cohorts DL1 (2.4mg) and DL2 (7.2mg) demonstrated 96–100% overall response rates and 100% progression-free survival at a 7.9-month median. All patients experienced treatment-emergent adverse events—neutropenia, fatigue and myalgia in 36–38%—with grade ≥3 events in 38.1–40.9% and cytokine release syndrome in 36–38%, including one grade 2 episode, but no discontinuations.
2. Competitive Position versus Lunsumio
AstraZeneca’s chemotherapy-free regimen will challenge Roche’s subcutaneous Lunsumio plus lenalidomide, which achieved 90% ORR but had a 14% discontinuation rate. Lunsumio’s outpatient dosing and existing approval in the relapse/refractory setting may support faster clinical uptake compared with the novel bispecific candidate.
3. Regulatory Advances: Capivasertib and Ultomiris
FDA approval of capivasertib with abiraterone and prednisone for PTEN-deficient metastatic prostate cancer followed Phase III data showing a 19% reduction in progression or death and a 7.5-month radiographic PFS improvement. Ultomiris secured Priority Review for immunoglobulin A nephropathy after demonstrating a 46.6% versus 5.6% reduction in proteinuria in Phase III.
