Akeso (9926) WCLC 2024 Presentation summary

Study background and objectives

• Recent phase III trials support neoadjuvant PD-(L)1 inhibitors plus chemotherapy for resectable NSCLC, with ivonescimab as a novel anti-PD-1/VEGF bispecific antibody showing promise in advanced NSCLC.

• This phase II study evaluates perioperative ivonescimab alone or with chemotherapy in resectable NSCLC (NCT05247684).

Study design and patient characteristics

• 60 patients with resectable stage II-IIIB (N2) NSCLC enrolled; 11 received ivonescimab monotherapy, 49 received ivonescimab plus chemotherapy.

• Neoadjuvant treatment followed by surgery and adjuvant therapy; primary endpoints were major pathological response (MPR) and safety.

• Most patients were male (85%), median age 64, predominantly squamous histology (75%), and ECOG PS 0 (98.3%).

Efficacy outcomes

• Ivonescimab + chemotherapy achieved MPR of 71.8% and pCR of 43.6%; monotherapy MPR was 60.0% and pCR 30.0%.

• In cohort 2, MPR and pCR rates were higher in squamous histology and PD-L1 ≥1% subgroups.

• Objective response rate (ORR) was 95.9% for combination and 90.9% for monotherapy; downstaging occurred in 63.6% (monotherapy) and 36.7% (combination).

• As of Aug 30, 2024, updated pCR and MPR rates in cohort 2 were 52.7% and 72.7%, respectively; for squamous NSCLC, pCR and MPR reached 63.6% and 84.1%.