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

Summit Therapeutics has announced data from the Phase III Harmoni trial for its investigational bispecific antibody, ivonescimab, to be presented at the IASLC 2025 World Conference on Lung Cancer. The trial aims to evaluate ivonescimab in combination with chemotherapy or monotherapy in patients with non-small cell lung cancer (NSCLC) and prostate NSCLC. Positive readouts have been reported in three single-region Phase III clinical trials in China.

Summit Therapeutics Inc. (NASDAQ: SMMT) has announced that data from its Phase III Harmoni trial, featuring the investigational bispecific antibody ivonescimab, will be presented at the 2025 World Conference on Lung Cancer (WCLC 2025) in Barcelona on September 7, 2025 [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 be delivered by Jonathan Goldman, MD, Professor of Medicine at UCLA.

The Harmoni trial aims to evaluate ivonescimab in combination with chemotherapy compared to placebo plus chemotherapy in patients with epidermal growth factor receptor (EGFR)-mutated, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who have progressed after treatment with a 3rd generation EGFR tyrosine kinase inhibitor (TKI) [1]. This is a significant clinical setting where previous PD-1 monoclonal antibodies have shown limited success in Phase III trials.

Ivonescimab, known as SMT112 in Summit’s license territories, is a novel, potential first-in-class investigational bispecific antibody that combines the effects of immunotherapy via a blockade of PD-1 with anti-angiogenesis effects associated with blocking VEGF into a single molecule [1]. The tetravalent structure of ivonescimab enables higher avidity in the tumor microenvironment, potentially improving efficacy and safety profiles compared to previous treatments.

Positive readouts have been reported in three single-region Phase III clinical trials in China, including HARMONi-A, HARMONi-2, and HARMONi-6 [1]. These trials evaluated ivonescimab in various settings, including in combination with chemotherapy and as monotherapy.

The presentation at WCLC 2025 will provide an opportunity for the oncology community to review the latest data on ivonescimab and its potential impact on the treatment of NSCLC. Summit Therapeutics continues to expand its clinical development of ivonescimab, with ongoing trials in various settings, including first-line metastatic NSCLC and squamous NSCLC.

References:
[1] https://www.morningstar.com/news/business-wire/20250814596038/ivonescimab-data-from-global-phase-iii-harmoni-study-to-be-showcased-at-presidential-symposium-at-wclc-2025