Ivonescimab Versus Pembrolizumab in First-Line PD-L1-Positive NSCLC: Positive Overall Survival Results from HARMONi-2 Presented at WCLC 2026

HONG KONG, Sept. 13, 2026 /PRNewswire/ -- Akeso, Inc. (9926.HK) today announced the presentation of positive overall survival (OS) results from the randomized, double-blind, multicenter, registrational Phase III HARMONi-2 study (AK112-303) at the 2026 World Conference on Lung Cancer (WCLC), organized by the International Association for the Study of Lung Cancer (IASLC). The study evaluated the company's first-in-class next-generation immuno-oncology therapy, ivonescimab, versus pembrolizumab as first-line treatment for patients with PD-L1-positive (PD-L1 TPS ≥1%) locally advanced or metastatic non-small cell lung cancer (NSCLC).

The findings were selected as a Late-Breaking Abstract (LBA) for oral presentation and included in the official WCLC press program.

On September 13, the WCLC official website published the Abstract data on overall survival (OS) from the HARMONi-2 study. On September 15, Professor Caicun Zhou, Principal Investigator of HARMONi-2, IASLC President, and Director of the Department of Oncology at Shanghai East Hospital, will deliver the formal oral presentation (Oral) at the conference, sharing the complete results of the HARMONi-2 study with the global industry.

As of the data cutoff on August 20, 2026, the median follow-up was 36 months, and a total of 234 overall survival (OS) events had occurred. For this OS analysis, a prespecified O'Brien-Fleming spending function was used, with a one-sided alpha of 0.0141.

Results showed that, compared with pembrolizumab, first-line treatment with ivonescimab significantly prolonged OS in patients with PD-L1-positive advanced NSCLC.  This finding met the prespecified statistical significance threshold and demonstrated clear clinical benefit. The overall survival benefit was generally consistent across prespecified subgroups, with particularly pronounced benefit observed in the PD-L1-high population.

1. Intention-to-Treat (ITT) Population: Median OS of 30.8 Months with Ivonescimab, 27% Reduction in Risk of Death

2. Overcoming Traditional Anti-VEGF Treatment Contraindications: No Significant Increase in Bleeding Risk Observed in High-Risk Squamous Patients

Squamous NSCLC patients accounted for 45.5% of the HARMONi-2 population, and non-squamous patients for 54.5%. Among squamous patients treated with ivonescimab, 72.2% had central tumors, 10.0% had tumor cavitation or necrosis, and 6.7% had tumors encasing major vessels.

These populations are traditionally considered contraindicated or high-risk for anti-VEGF therapies and have long lacked effective treatment options. However, no apparent increase in bleeding risk was observed with ivonescimab, and these patients showed favorable benefit.

3. Consistent OS Benefit with Ivonescimab Regardless of PD-L1 Expression Level, with Particularly Pronounced Benefit in the TPS ≥50% Population

4. Consistent OS Benefit with Ivonescimab Regardless of Histology (Squamous and Non-Squamous)

5. Favorable Overall Safety Profile with No New Safety Signals; Safety Characteristics Generally Consistent Between Arms

In May 2024, a prespecified interim analysis of progression-free survival (PFS) assessed by the Independent Data Monitoring Committee (IDMC) confirmed that HARMONi-2 met its primary PFS endpoint with statistically significant and clinically meaningful results. Median PFS was 11.14 months with ivonescimab versus 5.82 months with pembrolizumab (HR=0.51, P...