ASCO 2026: HARMONi-6 Meets Overall Survival Endpoint in Advanced Squamous NSCLC
Posted: Wednesday, June 24, 2026
According to Shun Lu, MD, PhD, of Shanghai Chest Hospital, and colleagues, in the Chinese phase III HARMONi-6 trial, the PD-1/VEGF bispecific antibody ivonescimab plus chemotherapy significantly improved overall survival vs tislelizumab plus chemotherapy in previously untreated patients with advanced squamous non–small cell lung cancer (NSCLC). The findings from this first planned overall survival analysis, which were presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract LBA4), also demonstrated a manageable safety profile.
In this clinical context, established treatment options include PD-(L)1 inhibitor–based chemoimmunotherapy combinations, such as pembrolizumab-based regimens in the United States and tislelizumab-based regimens in China. “Notably, ivonescimab plus chemotherapy is the first regimen to show clinical superiority over an active PD-1 inhibitor control arm in the first-line setting,” the investigators commented.
A total of 532 patients with stage III to IV disease were randomly assigned in a 1:1 ratio to receive paclitaxel and carboplatin plus either ivonescimab or tislelizumab, followed by maintenance monotherapy. At a median follow-up of 21.4 months, median overall survival was 27.9 months with ivonescimab vs 23.7 months with tislelizumab (hazard ratio [HR] = 0.66; one-sided P = .0017).
The overall survival benefit was found to be consistent across prespecified subgroups. Among patients with PD-L1 tumor proportion score (TPS) less than 1%, median overall survival was not estimable with ivonescimab vs 18.6 months with tislelizumab (HR = 0.64). Median overall survival was not estimable vs 27.3 months, respectively, among those with a TPS of at least 1% (HR = 0.68).
The investigational regimen appeared to be associated with a manageable safety profile that was consistent with prior reports. No new safety signals were observed.
“The dual-targeted approach of ivonescimab delivers improved survival outcomes with a favorable risk-benefit profile, establishing a compelling new standard of care in the management of advanced squamous NSCLC,” the investigators concluded.
Disclosure: For full disclosures of the study authors, visit coi.asco.org.
