HARMONi-A
The first phase 3 win for ivonescimab, in lung cancer that has stopped responding to EGFR pills, and the basis of its first approval in China.
Overview
322 patients. Median progression-free survival 7.1 versus 4.8 months (hazard ratio 0.46) with benefit across subgroups including patients who had received third-generation EGFR inhibitors; published in JAMA in 2024. NMPA approval May 2024, the first for any PD-1 x VEGF bispecific antibody. Summit's global HARMONi trial in the same setting met progression-free survival but not overall survival at its 2025 analysis, the basis of a US filing with a November 2026 action date.
- Median 7.1 vs 4.8 months with Ivonescimab + chemotherapy compared with Placebo + chemotherapy; about 2.3 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 54 percent lower chance of the event at any given time (hazard ratio 0.46).
- 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: EGFR-mutant non-squamous NSCLC after progression on an EGFR TKI, China: ivonescimab or placebo plus pemetrexed and carboplatin. People in a different situation may not see the same effect.
- The trial selected people by a biomarker (EGFR); 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.
Pages like this
not linked directly; found by shared links- TrialCameL
Shares Pemetrexed, Carboplatin, Non-small-cell lung cancer and the tag china.
- TrialORIENT-11
Shares Pemetrexed, Non-small-cell lung cancer and the tag china.
- ProductIcotinib
Shares EGFR, Non-small-cell lung cancer and the tag china.
- ProductFurmonertinib
Shares EGFR, Non-small-cell lung cancer and the tag china.
- TrialAENEAS
Shares EGFR, Non-small-cell lung cancer and the tag china.
- ProductSavolitinib
Shares EGFR, Non-small-cell lung cancer and the tag china.
- ProductAumolertinib
Shares EGFR, Non-small-cell lung cancer and the tag china.
- ProductAnlotinib
Shares VEGF / VEGFR, Non-small-cell lung cancer and the tag china.