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
A new combination therapy extends survival by over four months in advanced lung cancer, offering the first major breakthrough for this treatment class.
HARMONi-6 is a Phase 3 RCT (n=532) comparing ivonescimab — a novel bispecific antibody co-blocking PD-1 and VEGF — plus chemotherapy against a standard PD-1 inhibitor plus chemotherapy as first-line treatment in advanced squamous NSCLC. Ivonescimab demonstrated a meaningful OS advantage (27.9 vs 23.7 months; HR 0.66), meeting the pre-specified boundary and representing the first Phase 3 OS data for the PD-1+VEGF bispecific class.
What the study was
- Study design
- Phase 3 RCT (double-blind, randomized, active-controlled)
- Population
- Adults aged 18-75 with previously untreated unresectable stage IIIB/IIIC/IV squamous NSCLC, ECOG PS 0-1; median age 64 years; 93% male; conducted at 50 hospitals in China
- Sample size
- 532
- Category
- Treatment Innovation
- Maturity
- Potentially Practice-Changing
- Journal
- Lancet
Why it surfaced
Phase 3 RCT in Lancet showing OS HR 0.66 (p=0.0017) for PD-1+VEGF bispecific antibody vs standard PD-1 inhibitor in first-line squamous NSCLC; first Phase 3 OS confirmation for this bispecific class, directly practice-changing pending regulatory review.
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