The news at a glance
- Ivonescimab is a new antibody that does two jobs at the same time: it releases the brake on the immune system and stops the tumour from making new blood vessels [3].
- In people with advanced lung cancer, given with chemotherapy, it helped patients live longer than a widely used immunotherapy: patients typically lived about 4 months longer [1].
- In another study, given on its own, it had kept the disease under control almost twice as long as pembrolizumab [3].
- Both studies were done only in China [1, 3]; the drug is approved in China but not yet in the United States or Europe.
- Overall survival: how long patients lived.
- Progression-free survival: how long the disease did not get worse.
- Disease-free or event-free survival: how long the disease did not come back after treatment.
- Median: the number that half of patients were above and half below; for example, "a median of 10 months" means that in half of patients the disease stayed under control for at least 10 months.
- Phase 3: a large, careful study comparing a new drug with the usual treatment; the basis of most approvals.
Talk to your doctor about what this result means for you.
What was reported?
For physicians
Anti-PD-1 immunotherapy drugs such as pembrolizumab are the backbone of first-line treatment for non-small cell lung cancer without targetable mutations. By blocking PD-1 and VEGF at the same time, ivonescimab aims both to strengthen antitumour immunity and to reduce tumour angiogenesis [3].
In the double-blind phase 3 HARMONi-6 trial at 50 hospitals in China, 532 patients with untreated advanced squamous lung cancer received ivonescimab or tislelizumab (an anti-PD-1 drug) with paclitaxel and carboplatin [1]. The first report had shown median progression-free survival of 11.1 vs 6.9 months, regardless of PD-L1 expression [2].
The prespecified interim overall survival analysis has now been published: with a median follow-up of 21.4 months, median overall survival was 27.9 months with ivonescimab and 23.7 months with tislelizumab, crossing the prespecified significance boundary [1]. This is one of the first reports in which a PD-1/VEGF bispecific antibody has shown an overall survival advantage over anti-PD-1 immunotherapy in a phase 3 trial [1, 6].
What does this finding mean for patients?
Lung cancer is one of the deadliest cancers in the world [7]. These results show that a new generation of immunotherapy drugs that block two targets at once can help people live longer than current immunotherapies [1]. However, for now this drug is approved only in China, and all its large studies were done in Chinese patients. The immunotherapy treatments approved today remain effective, standard options; talk to your doctor about the most suitable treatment or the chance of taking part in a clinical trial.
Trial details and regimens (for physicians)
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Treatment regimens and doses: index3 regimens
- The overall survival analysis was performed after 204 deaths, before the planned 225 events were reached, "to meet regulatory timelines" [1].
- Treatment-related grade 3 or higher adverse events occurred in 69% vs 59% [1].
- 93% of HARMONi-6 patients were men and all were from China [1]. In the international HARMONi trial in EGFR-mutated patients after a TKI, progression-free survival improved (HR 0.52) but the overall survival difference was not significant (HR 0.79; 95% CI 0.62 to 1.01) [4].
- HARMONi-2 has not yet published overall survival data, and this has been questioned in The Lancet [5].
Ivonescimab trial regimens (investigational; not approved by the FDA or EMA)
HARMONi-6: ivonescimab + paclitaxel + carboplatin
Unresectable stage IIIB to IV squamous NSCLC, first line, ECOG 0 to 1Cycle length: Every 3 weeks
Unresectable stage IIIB to IV squamous NSCLC, first line, ECOG 0 to 1
Before prescribing: Common safety considerations| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Induction, 4 cycles | |||
| Ivonescimab | 20 mg/kg | IV | Day 1 |
| Paclitaxel + carboplatin | 175 mg/m² + AUC 5 | IV | Day 1 |
| Maintenance | |||
| Ivonescimab | 20 mg/kg | IV | Every 3 weeks |
Comparator arm: tislelizumab 200 mg with the same chemotherapy [2].
Evidence: HARMONi-6 (2026), HARMONi-6 (2025)
HARMONi-2: ivonescimab monotherapy
PD-L1-positive locally advanced or metastatic NSCLC without EGFR or ALK alterationsCycle length: Every 3 weeks
PD-L1-positive locally advanced or metastatic NSCLC without EGFR or ALK alterations
Before prescribing: Common safety considerations| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Ivonescimab | 20 mg/kg | IV | Every 3 weeks |
Comparator arm: pembrolizumab 200 mg every 3 weeks [3].
Evidence: HARMONi-2 (2025)
HARMONi: ivonescimab + pemetrexed + carboplatin
EGFR-mutated non-squamous NSCLC after progression on a third-generation TKICycle length: Every 3 weeks
EGFR-mutated non-squamous NSCLC after progression on a third-generation TKI
Before prescribing: Common safety considerations| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Ivonescimab | 20 mg/kg | IV | Day 1 |
| Pemetrexed + carboplatin | 500 mg/m² + AUC 5 | IV | Day 1 |
No significant difference in overall survival [4].
Evidence: HARMONi (2026)
Doses follow the trial protocol, guideline or official drug label (source given in the notes of each regimen). Before prescribing, check blood counts, renal and hepatic function, drug interactions and the patient’s condition, and adjust the dose according to the drug label.
Approval status, limitations and next steps
- Approval: according to the manufacturers, China's National Medical Products Administration (NMPA) approved ivonescimab + chemotherapy in August 2026 for first-line treatment of advanced squamous lung cancer (company announcement). The drug is not approved in the United States or Europe.
- All HARMONi-2 and HARMONi-6 data come from Chinese patients, and generalisability to other populations must be confirmed in global studies [1, 3].
- The HARMONi-6 overall survival analysis is an interim analysis, and longer follow-up is needed [1].
Main studies
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Key studies
2 itemsIvonescimab plus chemotherapy versus tislelizumab plus chemotherapy in advanced squamous non-small-cell lung cancer (HARMONi-6): interim overall survival analysis of a randomised, double-blind, phase 3 trial in China
Ivonescimab versus pembrolizumab for PD-L1-positive non-small cell lung cancer (HARMONi-2): a randomised, double-blind, phase 3 study in China
References
7 referencesShow all references, 7 with a study cardClose the reference list
Numbers in the text, such as [1], refer to these sources. Sources with a “Study card” button are summarised in the site’s evidence library.
- 1
- 2Ivonescimab plus chemotherapy versus tislelizumab plus chemotherapy as first-line treatment for advanced squamous non-small-cell lung cancer (HARMONi-6): a randomised, double-blind, phase 3 trial
- 3
- 4Ivonescimab plus chemotherapy versus placebo plus chemotherapy in patients with advanced EGFR-mutated non-small-cell lung cancer after disease progression on EGFR tyrosine kinase inhibitor therapy (HARMONi): a multicentre, randomised, double-blind, phase 3 trial
- 5Ivonescimab in advanced NSCLC: is progression-free survival enough, or are overall survival data also needed?
- 6Ivonescimab Plus Chemo Extends Squamous NSCLC Survival
- 7Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries
This page is based on reputable scientific sources and was last updated on 28 October 2026. The content of this website is for educational and informational purposes only and does not replace consultation, diagnosis or treatment by a specialist physician. Consult your treating physician about any treatment decision.
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