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Summit Therapeutics Inc. (NASDAQ:SMMT) ("Summit," "we," or the "Company") today announced that results from the Phase III HARMONi-A trial, conducted in China and sponsored by our partner, Akeso, Inc. ("Akeso," HKEX Code: 9926.HK), featuring the novel, potential first-in-class investigational bispecific antibody, ivonescimab, will be presented as part of the Annual Meeting of the Society for Immunotherapy of Cancer (SITC 2025) in National Harbor, Maryland (Washington D.C. metro area) on Friday, November 7, 2025 at 11:30am ET.
HARMONi-A evaluated ivonescimab combined with platinum-doublet 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 an EGFR tyrosine kinase inhibitor (TKI) against placebo plus platinum-doublet chemotherapy. This is a clinical setting with a patient population where PD-1 monoclonal antibodies have previously been unsuccessful in Phase III global clinical trials. HARMONi-A was the first Phase III study conducted with ivonescimab and now represents the first statistically significant overall survival (OS) benefit achieved by an ivonescimab regimen over a standard of care regimen.
HARMONi-A was a single region, multi-center, Phase III study conducted in China sponsored by Akeso with data generated and analyzed by Akeso. Via the results of HARMONi-A, this setting was the first of two settings which were approved by the National Medical Products Administration (NMPA), the health authority in China. In China, over 40,000 patients have been treated with ivonescimab in either a clinical or commercial setting.
Separately, Summit is sponsoring the HARMONi study, which is the first multiregional Phase III trial studying ivonescimab. HARMONi is evaluating ivonescimab plus platinum-doublet chemotherapy compared to placebo plus platinum-doublet chemotherapy in patients with EGFR mutated, locally advanced or metastatic non-squamous NSCLC who previously received a third generation EGFR TKI. Based on the results of the multiregional HARMONi study, we plan to submit a Biologics License Application (BLA); ivonescimab has not been approved by any regulatory authority in Summit's license territories, including the United States and Europe.
Posted In: SMMT
