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HARMONi-2

The first head-to-head trial in which a new drug beat Keytruda, in China; a survival benefit followed in 2026.

398 patients. PFS 11.1 vs 5.8 months (HR 0.51, WCLC 2024). In 2026 Akeso and Summit reported a statistically significant overall survival benefit for ivonescimab monotherapy versus pembrolizumab. Single-country trial; Western confirmation rests on HARMONi-3 and HARMONi-7.

Setting
First-line PD-L1-positive (TPS ≥1%) advanced NSCLC in China: ivonescimab vs pembrolizumab monotherapy
Phase
Phase 3
Sponsor
Akeso
Registry
Headline result
PFS HR 0.51; OS statistically significant (2026 announcement).
Reported
2024
Enrolled
398
Replication
Single-country (China) trial; OS immature. The global HARMONi-3 interim did not reproduce the PFS margin, so replication outside China is unresolved.

Outcomes

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In plain words
What these results mean for people, not percentages
398 people took part
Progression-free survival (IRRC)primarysurrogate endpoint
  • Median 11.1 vs 5.8 months with Ivonescimab compared with Pembrolizumab; about 5.3 months longer for half the group.
  • A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
  • Put another way, the treated group had about 49 percent lower chance of the event at any given time (hazard ratio 0.51, likely range 0.38 to 0.69).
  • This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
  • These results apply to the people the trial enrolled: First-line PD-L1-positive (TPS ≥1%) advanced NSCLC in China: ivonescimab vs pembrolizumab monotherapy. People in a different situation may not see the same effect.
  • The trial selected people by a biomarker (PD-L1); the result should not be assumed for people whose cancer does not have it.

Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.

398 participants enrolled.

Progression-free survival (IRRC)primary
HR 0.51 (0.38–0.69) · p <0.0001
Ivonescimab
11.1 mo
Pembrolizumab
5.8 mo
Source
EndpointArmnValueHR (95% CI)pSource
Progression-free survival (IRRC)primaryIvonescimab19811.1 months0.51 (0.38–0.69)<0.0001link
Pembrolizumab2005.8 months
Replication
Single-country (China) trial; OS immature. The global HARMONi-3 interim did not reproduce the PFS margin, so replication outside China is unresolved.

Connected

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