Summit Therapeutics to Present Ivonescimab Phase III HARMONi Trial Data at WCLC 2025

Summit Therapeutics will present Phase III HARMONi trial data for ivonescimab at the 2025 World Conference on Lung Cancer in Barcelona. The data shows significant improvement in progression-free survival in EGFR-mutant NSCLC patients. Ivonescimab combines immunotherapy and anti-angiogenesis effects with a novel bispecific antibody design. The study targets patients who have progressed after receiving a 3rd generation EGFR TKI treatment. The data will be presented by Dr. Jonathan Goldman from UCLA.

Summit Therapeutics Inc. (NASDAQ: SMMT) will present data from the Phase III HARMONi trial for ivonescimab at the 2025 World Conference on Lung Cancer (WCLC 2025) in Barcelona. The trial, which evaluated ivonescimab in combination with chemotherapy versus placebo plus chemotherapy in patients with epidermal growth factor receptor (EGFR)-mutated, locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed after treatment with a 3rd generation EGFR tyrosine kinase inhibitor (TKI), demonstrated significant improvement in progression-free survival (PFS) [1].

The data, to be presented by Dr. Jonathan Goldman, MD, Professor of Medicine at UCLA, shows a hazard ratio of 0.52 (95% CI: 0.41 – 0.66; p0.00001) for PFS in favor of ivonescimab, indicating a statistically significant and clinically meaningful improvement. While there was a positive trend in overall survival (OS) with a hazard ratio of 0.79 (95% CI: 0.62 – 1.01; p=0.057), it did not reach statistical significance [1].

Ivonescimab is a novel, potential first-in-class investigational bispecific antibody that combines the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. Its tetravalent structure allows for higher avidity in the tumor microenvironment (TME), potentially improving efficacy and safety profiles [1].

The presentation, titled "Ivonescimab vs Placebo Plus Chemo, Phase 3 in Patients with EGFR+ NSCLC Progressed with 3rd gen EGFR-TKI Treatment: HARMONi," will take place on Sunday, September 7, 2025, at 8:15am CET (2:15am ET) [1].

References:
[1] https://finance.yahoo.com/news/ivonescimab-data-global-phase-iii-110000374.html