#ESMO26 Ivonescimab (AK112): Can a PD-1/VEGF bispecific work as 1L monotherapy in IMDC favorable-risk mRCC?

Ph Ib/II, single-arm study
🔹 n=26 enrolled
🔹 Ivonescimab 30 mg/kg Q3W

🚨Encouraging activity with monotherapy🚨
🔹 ORR: 65%
🔹 DCR: 96%
🔹 Tumor shrinkage: 87%
🔹 irORR: 69.6%

At median FU 13.3 mo:
🔹 12-mo PFS: 85.5%
🔹 24-mo PFS: 55.4%
🔹 No deaths to date

Safety:
🔹 Grade 3–4 TRAEs: 26.9%
🔹 Most common TRAEs: proteinuria 42.3%, rhinitis 38.5%, pruritus 34.6%
🔹 No treatment-related deaths

🔑 Early single-arm data suggest meaningful activity of PD-1/VEGF bispecific monotherapy in favorable-risk ccRCC, a population where the optimal balance between efficacy and treatment intensity remains an important question.

@urotoday