In the latest report from the 2024 World Conference on Lung Cancer Presidential Symposium, significant developments have been uncovered in the treatment of advanced non-small cell lung cancer (aNSCLC). The focus was on a Phase 3 study comparing Ivonescimab (AK112) with Pembrolizumab as first-line treatment for PD-L1-positive aNSCLC. The study was conducted with a sample size of approximately 388 patients, and the interim analysis of progression-free survival (PFS) was planned when 185 PFS events occurred.
The results revealed that Ivonescimab demonstrated a statistically significant improvement in PFS compared to Pembrolizumab, with a hazard ratio (HR) of 0.51 and a 5.3 months improvement in median PFS. Ivonescimab showed a median PFS of 11.14 months, while Pembrolizumab exhibited a median PFS of 5.82 months. This improvement was consistent across major clinical subgroups, including PD-L1 expression and histology.
Additionally, Ivonescimab displayed higher overall response rate (ORR) and disease control rate (DCR) compared to Pembrolizumab, with an ORR of 50.0% and a DCR of 89.9% for Ivonescimab, as opposed to an ORR of 38.5% and a DCR of 70.5% for Pembrolizumab.
In terms of safety, Ivonescimab exhibited a manageable safety profile, consistent with previous studies. The most common treatment-related adverse events (TRAEs) were proteinuria and hypertension, and Ivonescimab demonstrated a tolerable safety profile in patients with squamous cell carcinoma (SQ) as well.
The study also evaluated the impact on quality of life, with Ivonescimab showing comparable, and in some cases, numerically better time to deterioration of global health status compared to Pembrolizumab.
It's important to note that the overall survival (OS) analysis was not matured at the time of the report, and the results are event-driven and will be reported in the future.
These findings suggest that Ivonescimab has the potential to offer improved outcomes for patients with PD-L1-positive aNSCLC as compared to the current standard of care. Today the company's shares have moved -1.8% to a price of $12.27. For more information, read the company's full 8-K submission here.