Data from a Phase 3 study revealed that ivonescimab demonstrates a statistically significant and clinically meaningful improvement in progression-free survival compared to pembrolizumab for patients with PD-L1-positive advanced non-small cell lung cancer. The results were presented today at the International Association for the Study of Lung Cancer (IASLC) 2024 World Conference on Lung Cancer.
The HARMONi-2 study randomized 398 patients from 55 centers in China to receive either ivonescimab (20 mg/kg) or pembrolizumab (200 mg) every three weeks. To be eligible for the trial, patients had to have untreated locally advanced or metastatic NSCLC, ECOG PS 0-1, PD-L1 positive (TPS ≥1%) but negative EGFR mutations or ALK rearrangements.
At the planned interim analysis, ivonescimab demonstrated a median PFS of 11.14 months, significantly longer than the 5.82 months observed with pembrolizumab. This represents a 49% reduction in the risk of progression or death (stratified hazard ratio [HR], 0.51; 95% CI, 0.38 to 0.69; p<0.0001).
According to Dr. Caicun Zhou, Shanghai Pulmonary Hospital in Shanghai, China, the benefit of ivonescimab was consistent across various patient subgroups, including those with squamous and non-squamous NSCLC, different levels of PD-L1 expression, and those with liver or brain metastases.
Dr. Zhou reported that safety profiles for both treatments were comparable, with no new safety signals identified for ivonescimab. Treatment-related serious adverse events (TRSAEs) occurred in 20.8% of patients receiving ivonescimab and 16.1% of those receiving pembrolizumab. Grade ≥3 immune-related adverse events were also similar between the two groups. In patients with squamous cell carcinoma, grade 3 or higher-treatment related adverse events were comparable between two groups.
"The findings from the HARMONi-2 study support the use of ivonescimab as a promising first-line treatment option for patients with PD-L1-positive advanced NSCLC, potentially offering a new and effective choice for managing this challenging disease," he said. "These results highlight ivonescimab's potential as a new standard of care."
About the IASLC:
The International Association for the Study of Lung Cancer (IASLC) is the only global organization dedicated solely to the study of lung cancer and other thoracic malignancies. Founded in 1974, the association's membership includes more than 10,000 lung cancer specialists across all disciplines in over 100 countries, forming a global network working together to conquer lung and thoracic cancers worldwide. The association also publishes the Journal of Thoracic Oncology, the primary educational and informational publication for topics relevant to the prevention, detection, diagnosis, and treatment of all thoracic malignancies. Visit www.iaslc.org
