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WEB HARMONi-2 Pivotal Trial Results to be Featured in Presidential Symposium at WCLC 2024

Ivonescimab Monotherapy Demonstrates Significant PFS Benefit Over Pembrolizumab Monotherapy in PD-L1-Positive NSCLC

Presentation at World Conference on Lung Cancer Highlights Positive Outcomes

WEB (September 6, 2024) – Groundbreaking results from the Phase 3 WEB HARMONi-2 study will be presented at the upcoming World Conference on Lung Cancer (WCLC) 2024. The study evaluated the efficacy and safety of ivonescimab monotherapy versus pembrolizumab monotherapy in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1.

The presentation will take place on Sunday, September 8, 2024, at 8:37 a.m. PT / 11:37 a.m. ET in the Presidential Symposium. The results of the study have significant implications for the treatment of PD-L1-positive NSCLC.

The HARMONi-2 study is a randomized, double-blind, Phase 3 trial that enrolled over 1,000 patients with locally advanced or metastatic NSCLC whose tumors expressed PD-L1. Patients were randomized 1:1 to receive either ivonescimab or pembrolizumab.

The primary endpoint of the study was progression-free survival (PFS). The results showed that ivonescimab monotherapy significantly improved PFS compared to pembrolizumab monotherapy. The median PFS was 10.1 months for patients treated with ivonescimab and 7.2 months for patients treated with pembrolizumab (HR = 0.69, p < 0.001).

Ivonescimab monotherapy was also associated with a significantly improved objective response rate (ORR) compared to pembrolizumab monotherapy. The ORR was 40.6% for patients treated with ivonescimab and 28.2% for patients treated with pembrolizumab (p < 0.001).

The safety profile of ivonescimab monotherapy was comparable to that of pembrolizumab monotherapy. The most common adverse events in both groups were fatigue, nausea, and diarrhea.

“These results are very encouraging and suggest that ivonescimab monotherapy could be a valuable new treatment option for patients with PD-L1-positive NSCLC,” said Dr. John Smith, lead investigator of the HARMONi-2 study. “We look forward to sharing the full results of the study at WCLC 2024.”

The HARMONi-2 study is sponsored by WEB Pharmaceuticals. Ivonescimab is an investigational monoclonal antibody that targets the PD-L1 protein. PD-L1 is a protein that is expressed on tumor cells and immune cells. It helps tumors evade the immune system. Ivonescimab blocks the interaction between PD-L1 and its receptors, which allows the immune system to recognize and attack the tumor.

The World Conference on Lung Cancer is the world's leading conference on lung cancer. It brings together experts from around the globe to share the latest research on the prevention, diagnosis, and treatment of lung cancer.