{"id":21295,"date":"2023-08-18T12:00:00","date_gmt":"2023-08-18T12:00:00","guid":{"rendered":"https:\/\/www.prnasia.com\/story\/archive\/4187698_CN87698_0"},"modified":"2023-08-18T12:00:00","modified_gmt":"2023-08-18T12:00:00","slug":"akeso-announced-first-patient-dosed-in-phase-3-trial-of-ivonescimab-versus-tislelizumab-for-first-line-treatment-of-squamous-nsclc","status":"publish","type":"post","link":"https:\/\/transmediavictoria.net.au\/?p=21295","title":{"rendered":"Akeso Announced First Patient Dosed in Phase 3 Trial of Ivonescimab versus Tislelizumab for First-line Treatment of Squamous NSCLC"},"content":{"rendered":"
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HONG KONG<\/span><\/span>, Aug. 18, 2023<\/span><\/span> \/PRNewswire\/ — Akeso Inc. (“Akeso”, 9926. HK) announced today that the first patient has been dosed in a head-to-head phase III trial of ivonescimab, a potential first-in-class investigational PD-1\/VEGF bi-specific antibody discovered by Akeso. The Phase III trial will evaluate the clinical efficacy and assess the safety of ivonescimab compared with tislelizumab in combination with chemotherapy as first-line treatment of locally advanced or metastatic squamous non-small cell lung cancer (sq-NSCLC).<\/p>\n

The international multicenter Phase III clinical trial of ivonescimab for this specific indication is currently ongoing. According to the latest clinical development plan for ivonescimab released by Summit Therapeutics, a partner of Akeso in the global development of ivonescimab, the international multicenter Phase III clinical study of ivonescimab in combination with chemotherapy versus pembrolizumab in combination with chemotherapy for first-line treatment of metastatic sq-NSCLC (HARMONi-3 ) is scheduled to dose the first patient in the second half of 2023.<\/p>\n

The use of PD- (L)1 inhibitors in conjunction with chemotherapy is the current standard of care (SOC) for lung cancer worldwide, especially in the United States<\/span> and China<\/span>. However, despite this approach, there is still significant room for improvement in terms of prognosis, as there remains an extensive unmet need.<\/p>\n

Currently, ivonescimab has been engaged in several Phase III head-to-head trials compared with standard of care PD-(L)1 inhibitors for lung cancer in developed countries worldwide, including China<\/span>, the United States<\/span>, Europe<\/span>, and other developed countries. Akeso and Summit are determined and confident in pursuing stronger evidence-based medical research for ivonescimab, with a specific emphasis on the drug’s clinical value. These efforts aim to expedite the drug’s time to market and ensure its commercial success on a global scale.<\/p>\n

Following an 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:<\/p>\n