Phase 2 trial of perioperative ivonescimab with or without chemotherapy in resectable non-small cell lung cancer

Resectable non-small cell lung cancer (NSCLC) carries a high risk of postoperative recurrence. A phase 2 trial at Tianjin Medical University Cancer Institute & Hospital and the Fourth Hospital of Hebei Medical University (China) evaluated neoadjuvant ivonescimab monotherapy (cohort 1; n=10) or in combination with chemotherapy (cohort 2; n=67), followed by surgery and adjuvant ivonescimab. In cohort 2, the major pathological response (MPR) rate was 70.1% (95% 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% (95% CI 26.2-87.8). Among patients who achieved MPR, 83.3% in cohort 1 and 97.9% in cohort 2 had residual viable tumor of ≤ 5%. Grade 3 or 4 treatment-related adverse events occurred in 36.4% of patients in cohort 1 and 30.4% of those in cohort 2, with no grade 3 or higher hemorrhage or treatment-related death. Treatment-related surgery delay occurred in one patient. Surgery-related adverse events related to ivonescimab occurred in 10% and 10.4% in the two cohorts, respectively. The authors conclude that these data support perioperative ivonescimab with or without chemotherapy as a promising strategy for resectable NSCLC.