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, five 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:

• An international multicenter Phase III study (HARMONi) of Ivonescimab in combination with chemotherapy for patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC progressing on third-generation EGFR-TKI therapy. This study was led by Professor Li Zhang. Akeso's partner, Summit Therapeutics("Summit"), has completed the first patient dosing in the United States.
• An international multicenter Phase III study of ivonescimab in combination with chemotherapy versus pembrolizumab monoclonal antibody in combination with chemotherapy as the first-line treatment for metastatic squamous NSCLC is conducted in the United States (HARMONi-3). Summit intends to dose the first patient in the second half of 2023.
• A Phase III study of ivonescimab monotherapy versus pembrolizumab monotherapy as the first-line treatment for NSCLC patients with positive PD-L1 expression in China is undergoing. The enrollment will be completed soon.
• A Phase III study in China for the first-line treatment of advanced squamous NSCLC with ivonescimab in combination with chemotherapy versus tislelizumab in combination with chemotherapy is undergoing.

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:

• Ivonescimab combined with chemotherapy for the treatment of EGFR-mutated locally advanced or metastatic NSCLC patients who progressed on EGFR-TKI treatment.
• Ivonescimab as the first-line treatment for locally advanced or metastatic NSCLC patients with positive PD-L1 expression.
• Ivonescimab combined with docetaxel for the treatment of locally advanced or metastatic NSCLC patients who failed to respond to prior PD-(L)1 inhibitor combined with platinum-based doublet chemotherapy.