Posted: Monday, September 16, 2024
Caicun Zhou, MD, PhD, of Shanghai Pulmonary Hospital, Tongji University School of Medicine, China, and colleagues conducted the HARMONi-2 study to compare PD-1 inhibitors—the investigational ivonescimab vs pembrolizumab—as a first-line therapy for PD-L1–positive, advanced non–small cell lung cancer (NSCLC). The primary analysis of this study, which supports invonescimab monotherapy as a new first-line treatment option in this patient population, was presented during the International Association for the Study of Lung Cancer (IASLC) 2024 World Conference on Lung Cancer (WCLC; Abstract PL02.04).
“Compared to pembrolizumab, ivonescimab demonstrated a statistically significant and clinically meaningful improvement in progression-free survival in PD–L1 positive NSCLC,” the investigators concluded.
This phase III study enrolled 398 patients with previously untreated, locally advanced or metastatic, PD-L1–positive NSCLC. Participants were randomly assigned on a 1:1 basis to receive 20 mg/kg of ivonescimab (n = 198) or 200 mg of pembrolizumab (n = 200) every 3 weeks. Randomization was stratified by clinical stage, PD-L1 expression, and histology.
Treatment with ivonescimab yielded a significantly longer progression-free survival compared with pembrolizumab (P < .0001). Of note, this benefit appeared to be consistent across subgroups, including those with liver (hazard ratio [HR] = 0.47) and brain (HR = 0.55) metastases.
Overall, treatment-related adverse events were reported more frequently with ivonescimab than with pembrolizumab (20.8% vs 16.1%). However, immune-related adverse events of grade 3 or higher were found to be more common with pembrolizumab vs ivonescimab (8.0% vs 7.1%). One interesting finding was that in patients who had squamous cell carcinoma histology, ivonescimab demonstrated a “very manageable safety profile,” the study authors noted. Treatment-related severe adverse events were observed in less than 20% of both treatment arms.
Disclosure: For full disclosures of the study authors, visit wclc2024.iaslc.org.
2024 World Conference on Lung Cancer