A newer report of this study has been published: Ivonescimab 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 (2026)
In this study, patients with advanced squamous lung cancer who had not yet had any treatment received either the drug ivonescimab or the immunotherapy drug tislelizumab, together with chemotherapy. Patients in the ivonescimab group lived longer without their disease getting worse (median 11.1 months versus 6.9 months). Serious side effects of treatment were slightly more common in the ivonescimab group (64% versus 54%), but the authors considered them manageable. These results come from a fairly short follow-up, and the treatment decision should be made with the treating doctor.
Unresectable stage IIIB to IV squamous NSCLC, first line, ECOG 0 to 1
| 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.
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.
Ivonescimab 20 mg/kg IV with paclitaxel 175 mg/m² IV and carboplatin IV (AUC 5 mg/mL per min) every 3 weeks for 4 cycles; then maintenance monotherapy with ivonescimab 20 mg/kg for up to 24 months.
Tislelizumab 200 mg IV with paclitaxel 175 mg/m² IV and carboplatin IV (AUC 5 mg/mL per min) every 3 weeks for 4 cycles; then maintenance monotherapy with tislelizumab 200 mg for up to 24 months.
Source of the regimen details: Abstract of the paper
Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.
Patients aged 18 to 75 years with pathologically confirmed, previously untreated, unresectable stage IIIB, IIIC or IV squamous non-small-cell lung cancer (NSCLC), with an ECOG performance status of 0 or 1. Of 761 patients screened, 532 (70%) were enrolled and randomised.
Primary endpoint: progression-free survival (PFS) assessed by an independent imaging review committee according to RECIST version 1.1 in all randomised patients. Safety (treatment-related adverse events and serious adverse events, as well as immune-related or VEGF inhibition-related adverse events) was assessed in all randomised patients who received at least one dose of study treatment. Randomisation was stratified by disease stage (IIIB or IIIC versus IV) and PD-L1 tumour proportion score (≥1% versus <1%).
Grade 3 or higher treatment-related adverse events: 170 patients (64%) in the ivonescimab group versus 144 patients (54%) in the tislelizumab group. Grade 3 or higher immune-related adverse events: 24 patients (9%) versus 27 patients (10%). Grade 3 or higher treatment-related bleeding: 5 patients (2%) in the ivonescimab group versus 2 patients (1%) in the tislelizumab group.
Based on the abstract, ivonescimab plus chemotherapy improved progression-free survival compared with tislelizumab plus chemotherapy in previously untreated advanced squamous NSCLC, and the authors proposed it as a new first-line option. The abstract gives no information on regulatory approvals or the place of this regimen in treatment guidelines; the drug's licensing status and guideline recommendations should be checked separately. A correction has also been published for this paper (Lancet 2026;407:226), which should be read before citing it.
Median follow-up was short (10.3 months), and the upper limit of the confidence interval for median PFS in the ivonescimab group was not yet estimable. Overall survival data are not reported in the abstract. The study was conducted only at centres in China and was funded by the drug's manufacturer (Akeso Biopharma); several authors are employees of the company. The study is still ongoing for treatment and follow-up. Grade 3 or higher treatment-related adverse events and bleeding were numerically more frequent in the ivonescimab group.
This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.
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