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Including ivonescimab, a first-in-class bispecific antibody concentrating on each PD-1 and VEGF, to chemotherapy considerably extended progression-free survival (PFS) in comparison with chemotherapy alone in sufferers with superior non-small cell lung most cancers (NSCLC) harboring EGFR mutations whose illness progressed on third-generation EGFR tyrosine kinase inhibitors (TKIs).
Outcomes from the worldwide Section III HARMONi trial had been offered by Jonathan Goldman, UCLA Well being, Los Angeles on the Worldwide Affiliation for the Examine of Lung Most cancers (IASLC) 2025 World Convention on Lung Most cancers (WCLC).
The randomized, double-blind, placebo-controlled research enrolled 438 sufferers worldwide, together with 38% from North America and Europe, with a median age of 62 years. Almost one-quarter (24.7%) had mind metastases at research entry. Sufferers obtained ivonescimab (20 mg/kg) or placebo together with pemetrexed and carboplatin for 4 cycles, adopted by upkeep remedy.
On the major evaluation (N=345; median follow-up 22.3 months), ivonescimab plus chemotherapy diminished the chance of illness development or demise by 48% in comparison with chemotherapy alone (HR 0.52; 95% CI: 0.41–0.66; P
Median PFS was 6.8 months (95% CI: 5.7–7.1) versus 4.4 months (95% CI: 4.1–5.5). The PFS profit was constant throughout all predefined subgroups, together with sufferers with mind metastases (HR 0.34; 95% CI: 0.20–0.57) and Western sufferers.
At closing general survival (OS) evaluation (median follow-up 29.7 months), median OS was 16.8 months with ivonescimab versus 14.0 months with chemotherapy alone (HR 0.79; 95% CI: 0.62–1.01; P=0.0570). The general response fee was larger within the ivonescimab group (44.7% vs. 34.2%), and intracranial PFS was additionally improved.
Grade ≥3 treatment-related antagonistic occasions occurred in 50.0% of sufferers receiving ivonescimab and 42.2% within the management arm, mostly laboratory abnormalities. VEGF-related occasions, together with reversible hypertension and proteinuria, had been extra frequent with ivonescimab however usually manageable. Remedy-related deaths had been uncommon (1.8% vs. 2.3%).
“Ivonescimab plus chemotherapy provided a clinically meaningful and statistically significant improvement in progression-free survival while maintaining a favorable safety profile in this difficult-to-treat patient population,” stated Dr. Goldman.
“The benefits were seen regardless of brain metastases status or geographic region and were supported by a positive overall survival trend.”
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Worldwide Affiliation for the Examine of Lung Most cancers
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Ivonescimab + chemotherapy improves progression-free survival in sufferers with EGFR+ NSCLC (2025, September 7)
retrieved 7 September 2025
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