Akeso (9926) ESMO 2024 Presentation summary

Study rationale and objectives

• FOLFOXIRI plus anti-VEGF therapy is standard first-line for unresectable mCRC with MSS or pMMR status.

• PD-1/PD-L1 inhibitors show limited efficacy in MSS/pMMR mCRC but are recommended for MSI-high/dMMR cases.

• Ivonescimab targets PD-1 and VEGF, aiming for synergistic anti-tumor effects; ligufalimab targets CD47 to enhance activity.

• The study evaluates ivonescimab with or without ligufalimab plus FOLFOXIRI as first-line therapy.

Study design and patient characteristics

• Phase 2 trial (NCT05382442) randomized 40 patients to two arms: ivonescimab + FOLFOXIRI or ivonescimab + ligufalimab + FOLFOXIRI.

• Median follow-up was 9.0–9.6 months; median age was 58 years; 50% had ECOG PS 1.

• Most patients had MSS/pMMR tumors and synchronous metastasis; liver involvement was common.

• Patients with MSI-high or dMMR tumors were excluded.

Efficacy results

• ORR was 81.8% for ivonescimab + FOLFOXIRI and 88.2% for ivonescimab + ligufalimab + FOLFOXIRI.

• DCR reached 100% in both groups.

• Estimated 9-month PFS rates were 81.4% and 86.2% for the two groups, respectively; median PFS not reached.