Perioperative ivonescimab with or without chemotherapy in resectable non-small cell lung cancer: a phase 2 trial

Year: 2026

Type: article

Abstract: Resectable non-small cell lung cancer (NSCLC) carries a high risk of postoperative recurrence, underscoring the need for effective perioperative therapies. This nonrandomized, noncomparative phase 2 trial evaluated neoadjuvant ivonescimab monotherapy (cohort 1) or in combination with chemotherapy (cohort 2), followed by surgery and adjuvant ivonescimab. In cohort 2, the major pathological response (MPR) rate was 70.1% (47/67; 95% confidence interval (CI) = 57.7-80.7); the lower bound of the 80% two-sided CI exceeded the historical control rate of 41% and the primary endpoint was met. The MPR rate in cohort 1 was 60.0% (6/10; 95% CI = 26.2-87.8). Among patients who achieved MPR, 83.3% (5/6) in cohort 1 and 97.9% (46/47) in cohort 2 had residual viable tumor (RVT) of ≤5%, respectively. Grade 3 or higher treatment-related adverse events (AEs) occurred in 36.4% (4/11) patients in cohort 1 and 30.4% (24/79) of those in cohort 2, with no grade 3 or higher hemorrhage or treatment-related death. Treatment-related surgery delay occurred in one (1.3%) patient. Surgery-related AEs related to ivonescimab occurred in 10.0% (1/10) and 10.4% (7/67) patients in the two cohorts, respectively, with no grade 3 or higher events reported. These data support perioperative ivonescimab with or without chemotherapy as a promising strategy for resectable NSCLC. ClinicalTrials.gov identifier: NCT05247684 .

Source: Nature Medicine

DOI: 10.1038/s41591-026-04745-4

Institutions: Tianjin Medical University Cancer Institute and Hospital, Tianjin Medical University, Fourth Hospital of Hebei Medical University

Language: English

Topic: Lung Cancer Diagnosis and Treatment

Subfield: Pulmonary and Respiratory Medicine

Field: Medicine

Domain: Health Sciences

SDG: Good health and well-being

Open Access status: hybrid

Estimated APC paid: $12,690

OpenAlex ID: W7225240609