Ivonescimab Monotherapy Demonstrates a Statistically Significant & Clinically Meaningful Benefit Compared to Pembrolizumab Monotherapy in PD-L1-Positive Advanced NSCLC in Akeso’s HARMONi-2 Study Conducted in China
Updated overall survival data from the Phase III HARMONi-2 trial showed ivonescimab monotherapy reduced the risk of death by 27% versus pembrolizumab monotherapy in PD-L1-positive advanced NSCLC, with a stratified hazard ratio of 0.73 (95% CI: 0.57, 0.95; p=0.009) and median OS of 30.8 months versus 22.6 months — an 8.2-month improvement on 36 months of follow-up. Benefit was seen across key subgroups, strongest in PD-L1 high expressers (HR 0.58), though PD-L1 low (HR 0.85) and non-squamous (HR 0.79) subgroups were not statistically significant; safety remained manageable with no new signals. The data, generated and analyzed by partner Akeso in China, are being presented at WCLC 2026.
Key figures
- Drug Name
- ivonescimab (SMT112 in Summit territories; AK112 elsewhere)
- Phase Of Trial
- Phase 3
- Os p value
- 0.009
- Pdufa date
- November 14, 2026
- Serious traes
- 29.9% ivonescimab vs 21.6% pembrolizumab
- Os hazard ratio
- 0.73
- Intent to treat n
- 398
- Phase3 studies total
- 16
- Trae discontinuation
- 4.1% ivonescimab vs 5.0% pembrolizumab
- Pdl1 low hazard ratio
- 0.85
- Squamous hazard ratio
- 0.65
- Os confidence interval
- 95% CI: 0.57, 0.95
- Pdl1 high hazard ratio
- 0.58
- Prior pfs hazard ratio
- 0.51
- Median follow up months
- 36
- Risk of death reduction
- 27%
- Non squamous hazard ratio
- 0.79
- Harmoni7 target enrollment
- 780
- Median os improvement months
- 8.2
- Median os ivonescimab months
- 30.8
- Median os pembrolizumab months
- 22.6
AI analysis
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