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Data from a Phase 3 study has 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 the 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.".
