Minhua Chu, Managing Partner at TransitionValue Partner, shared a post on X:
“WCLC 2025: $SMMT While investigators of HARMONi still maintained in a presentation that the PFS benefit was consistent across all predefined subgroups, a longer-term follow-up showed that, in European and North American patients, ivonescimab’s PFS improvement was 33% (hazard ratio 95% CI: 0.45-1.00), which is notably lower than the 45% recorded by Chinese patients. The risk reduction for the overall trial was 43% at the longer follow-up.
While PFS met its overall mark in HARMONi, ivonescimab has disappointed when it comes to overall survival (OS), missing the trial’s other dual primary endpoint.
The presentation at WCLC confirms that HARMONi missed OS at its final analysis. Confirming what Summit had previously disclosed, the death risk was 21% (HR 95% CI: 0.62-1.01) in favor of ivonescimab and chemo, with a p value of 0.057, while the statistical significance bar was set at a p value of 0.0448.”
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