Adding ivonescimab, a first-in-class bispecific antibody targeting some PD-1 and VEGF, to chemotherapy importantly prolonged progression-free endurance (PFS) compared to chemotherapy unsocial successful patients pinch precocious non-small compartment lung crab (NSCLC) harboring EGFR mutations whose illness progressed connected third-generation EGFR tyrosine kinase inhibitors (TKIs).
Results from nan world Phase 3 HARMONi proceedings were presented coming by Jonathan Goldman, UCLA Health, Los Angeles astatine nan International Association for nan Study of Lung Cancer (IASLC) 2025 World Conference connected Lung Cancer (WCLC).
The randomized, double-blind, placebo-controlled study enrolled 438 patients worldwide, including 38% from North America and Europe, pinch a median property of 62 years. Nearly one-quarter (24.7%) had encephalon metastases astatine study entry. Patients received ivonescimab (20 mg/kg) aliases placebo successful operation pinch pemetrexed and carboplatin for 4 cycles, followed by attraction therapy.
At nan superior study (N=345; median follow-up 22.3 months), ivonescimab positive chemotherapy reduced nan consequence of illness progression aliases decease by 48% compared to chemotherapy unsocial (HR 0.52; 95% CI: 0.41–0.66; P<0.001). Median PFS was 6.8 months (95% CI: 5.7–7.1) versus 4.4 months (95% CI: 4.1–5.5). The PFS use was accordant crossed each predefined subgroups, including patients pinch encephalon metastases (HR 0.34; 95% CI: 0.20–0.57) and Western patients.
At last wide endurance (OS) study (median follow-up 29.7 months), median OS was 16.8 months pinch ivonescimab versus 14.0 months pinch chemotherapy unsocial (HR 0.79; 95% CI: 0.62–1.01; P=0.0570). The wide consequence complaint was higher successful nan ivonescimab group (44.7% vs. 34.2%), and intracranial PFS was besides improved.
Grade ≥3 treatment-related adverse events occurred successful 50.0% of patients receiving ivonescimab and 42.2% successful nan power arm, astir commonly laboratory abnormalities. VEGF-related events, including reversible hypertension and proteinuria, were much predominant pinch ivonescimab but mostly manageable. Treatment-related deaths were uncommon (1.8% vs. 2.3%).
Ivonescimab positive chemotherapy provided a clinically meaningful and statistically important betterment successful progression-free endurance while maintaining a favorable information floor plan successful this difficult-to-treat diligent population. The benefits were seen sloppy of encephalon metastases position aliases geographic region and were supported by a affirmative wide endurance trend."
Dr. Jonathan Goldman, UCLA Health, Los Angeles