In patients with advanced squamous lung cancer who had not yet been treated, the new drug ivonescimab, which both activates the immune system and blocks the growth of the tumour's blood vessels, given with chemotherapy, lengthened life compared with a commonly used immunotherapy drug (tislelizumab) given with chemotherapy; however, severe side effects and bleeding were slightly more common.
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 + paclitaxel 175 mg/m² IV + carboplatin AUC 5 IV, every 3 weeks for 4 cycles; then single-agent ivonescimab 20 mg/kg maintenance (every 3 weeks) for up to 24 months.
Tislelizumab 200 mg IV + paclitaxel 175 mg/m² IV + carboplatin AUC 5 IV, every 3 weeks for 4 cycles; then single-agent tislelizumab 200 mg maintenance (every 3 weeks) for up to 24 months.
Source of the regimen details: Abstract of the initial HARMONi-6 report (Chen et al., Lancet 2025; PMID 41125109) and ClinicalTrials.gov NCT05840016; the full text was not available in PMC.
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 unresectable stage IIIB, IIIC or IV squamous non-small-cell lung cancer (pathologically confirmed), no prior systemic therapy for advanced disease, ECOG performance status 0 or 1, measurable disease and adequate organ function; 50 hospitals in China. Key exclusion criteria: non-squamous histology, sensitising EGFR mutation, ALK translocation, ROS1 rearrangement, MET exon 14 mutation or RET fusion, active central nervous system metastases, active autoimmune disease requiring systemic treatment in the past 2 years, myocardial infarction, unstable angina or congestive heart failure in the past 12 months. Randomisation was stratified by stage (IIIB/IIIC versus IV) and PD-L1 TPS (1% or more versus less than 1%). 93% men; median age 64 years.
Primary endpoint: progression-free survival by independent radiology review committee (RECIST 1.1). Overall survival was a key secondary endpoint.
Interim overall survival analysis: grade 3 or higher treatment-related adverse events occurred in 184 (69%) of 266 patients in the ivonescimab group and 156 (59%) of 265 patients in the tislelizumab group. Grade 3 or higher bleeding was seen in 7 (3%) and 2 (1%), respectively. In the initial report (2025; median follow-up 10.3 months): grade 3 or higher treatment-related adverse events 64% versus 54%, grade 3 or higher immune-related adverse events 9% versus 10%, and grade 3 or higher treatment-related bleeding 2% versus 1%. Discontinuation rates are not given in the abstracts.
One of the first overall survival advantages for a PD-1/VEGF bispecific antibody over anti-PD-1 immunotherapy plus chemotherapy in a phase 3 trial. According to the manufacturer, this regimen was approved in China in August 2026 for first-line treatment of advanced squamous lung cancer; it is not approved in the USA or Europe.
China only; 93% men; interim analysis brought forward to meet regulatory deadlines; relatively short follow-up.
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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