Akeso (9926) ASCO 2024 Presentation summary

Study background and objectives

• Patients with EGFR-mutant NSCLC often develop resistance to TKIs, necessitating new therapies.

• Ivonescimab is a bispecific antibody targeting PD-1 and VEGF, showing promise in prior studies.

• The phase 3 HARMONI-A trial compared ivonescimab plus chemotherapy to chemotherapy alone in this population.

Study design and patient population

• Double-blind, randomized, multi-center phase 3 trial at 55 sites in China, enrolling 322 patients.

• Eligible patients had stage IIIB/IV non-squamous NSCLC with EGFR-sensitive mutations and ECOG PS 0-1.

• Stratification included prior 3rd-gen EGFR-TKI use and brain metastases.

Efficacy results

• Median PFS was 7.1 months for ivonescimab plus chemo vs 4.8 months for placebo plus chemo (HR 0.46, p<0.001).

• PFS benefit was consistent across all subgroups, including those with brain metastases and different EGFR mutations.

• ORR was 50.6% and DCR 93.1% for ivonescimab plus chemo, both higher than placebo plus chemo.

• Median OS at 52% data maturity: 17.1 months (ivonescimab) vs 14.5 months (placebo), HR 0.80.