Ivonescimab Outperforms Pembrolizumab in Phase 3 Study for First-Line Treatment of PD-L1-Positive Advanced NSCLC In HARMONi-2 Study

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.

SAN DIEGO, Sept. 8, 2024 /PRNewswire-PRWeb/ -- 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 greater than or equal to 1 percent) 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 prercent reduction in the risk of progression or death (stratified hazard ratio {HR}, 0.51; 95% CI, 0.38 to 0.69; p less than 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 percent of patients receiving ivonescimab and 16.1 percent 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 http://www.iaslc.org for more information.

About the WCLC:
The World Conference on Lung Cancer (WCLC) is the world's largest meeting dedicated to lung cancer and other thoracic malignancies, attracting nearly 7,000 researchers, physicians and specialists from more than 100 countries. The goal is to increase awareness, collaboration and understanding of lung cancer, and to help participants implement the latest developments across the globe. The conference will cover a wide range of disciplines and unveil several research studies and clinical trial results. For more information, visit https://wclc2024.iaslc.org.

Media Contact

Chris Martin, IASLC, 6306702745, [email protected], www.iaslc.org

SOURCE IASLC