HONG KONG, Aug. 7, 2023 /PRNewswire/ -- Akeso Inc. ("Akeso", the "Company"; 9926.HK), a commercial-stage biopharmaceutical company focused on developing and commercializing first-in-class and best-in-class innovative medicines globally, announced today that eClinical Medicine(IF:15.1), a sub-journal of The Lancet, recently published the results of a phase II clinical trial of ivonescimab(PD-1/VEGF bispecific antibody) combined with chemotherapy for the treatment of non-small cell lung cancer (NSCLC). The study was led by Professor Li Zhang of the Sun Yat-Sen University Cancer Center.
Full article: https://authors.elsevier.com/sd/article/S2589537023002833
Ivonescimab is the world's first PD-1/VEGF bispecific antibody for which a New Drug Application (NDA) has been submitted. Based on the published results, the combination of ivonescimab and platinum-doublet showed promising antitumor activity for first-line treatment of advanced NSCLC without driver mutation, as well as for advanced NSCLC patients with EGFR-activating mutation that failed prior EGFR-TKI therapy. Additionally, AK112 in combination with docetaxel has shown favorable antitumor activity in advanced NSCLC patients who failed prior treatments with systemic platinum-based chemotherapy and PD-1/L1 inhibitor.
Following the acceptance of marketing application for an indication of ivonescimab by the China CDE, four pivotal registrational Phase III clinical trials have been initiated/are being conducted worldwide, including three head-to-head trials with PD-1 monoclonal antibody as the positive control drug and two international multicenter Phase III clinical trials:
It is also notable that owing to its remarkable clinical value, ivonescimab has received breakthrough therapy designation status in China from the NMPA for three indications: