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Multiple Ivonescimab Data Sets from Phase III Studies in Advanced NSCLC Patient Populations to be Featured at ELCC 2026

SMMT
  • Summit Therapeutics will present three updated ivonescimab posters at the 2026 European Lung Cancer Congress (ELCC 2026) in Copenhagen on Friday, March 27 from 1:00 to 2:00 pm CET.
  • The first poster details intracranial efficacy data from the global HARMONi Phase III study, showing ivonescimab plus chemotherapy improved intracranial progression-free survival to 10.1 months versus 6.5 months for chemotherapy alone in patients with baseline brain metastases (HR 0.53; p=0.0068).
  • The first poster also reports that patients without baseline brain metastases experienced improved intracranial progression-free survival of 15.7 months with ivonescimab plus chemotherapy compared to 11.6 months with chemotherapy alone (HR 0.72; p=0.0172).
  • No new safety signals were identified across brain metastasis subgroups in the HARMONi study, which enrolled patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC previously treated with an EGFR TKI.
  • The second poster presents health-related quality of life data for patients in the HARMONi trial who received ivonescimab plus chemotherapy versus chemotherapy alone.
  • The third poster covers health-related quality of life data from the HARMONi-2 study in China, comparing ivonescimab monotherapy against pembrolizumab monotherapy in PD-L1 positive NSCLC patients.
  • HARMONi data was generated and analyzed by Summit Therapeutics, while HARMONi-2 data was generated and analyzed by collaboration partner Akeso Inc.
  • A Biologics License Application (BLA) for ivonescimab based on HARMONi data was submitted to the FDA in late 2025, accepted for filing in January 2026, with a PDUFA date set for November 14, 2026.
  • Ivonescimab is a bispecific antibody combining PD-1 blockade with VEGF inhibition, currently under development in 15 Phase III trials across various cancer types including NSCLC, colorectal cancer, head and neck cancer, and others.
  • Over 4,000 patients have been treated with ivonescimab in global clinical studies, with over 60,000 treated in commercial settings in China.
  • Ivonescimab received initial marketing authorization in China in May 2024 and was granted Fast Track designation by the US FDA for the HARMONi trial setting.