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 randomised 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.”

Source: International Association for the Study of Lung Cancer