On October 30, 2023 Akeso (9926.HK) announced that the results of a phase Ib clinical trial for PD-1/VEGF bispecific antibody ( ivonecimab AK112/SMT112 ) as first- or second-line therapy for advanced or metastatic immunotherapy naïve non-small-cell lung cancer (NSCLC) were published in the Journal of Thoracic Oncology (JTO), the official journal of the International Association for the Study of Lung Cancer (IASLC) (Press release, Akeso Biopharma, OCT 30, 2023, View Source;or-second-line-therapy-for-advanced-or-metastatic-immunotherapy-naive-non-small-cell-lung-cancer-301971154.html [SID1234636459]). The principal investigator of this study is Prof. Caicun Zhou, MD, PhD, from Shanghai Pulmonary Hospital, affiliated with Tongji University.
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Previously, the clinical results of ivonescimab in combination with chemotherapy for NSCLC were published in the eClinical Medicine (part of The Lancet). The monotherapy results published in JTO represents another significant recognition of the clinical value of ivonescimab.
The phase Ib study, published in JTO, aims to determine the optimal dose, safety, and efficacy of ivonescimab monotherapy as a first- or second-line treatment for advanced NSCLC patients. Early data on ivonescimab in NSCLC was also presented at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) meeting.
From the data published in JTO, patients with advanced or metastatic NSCLC can benefit from ivonescimab monotherapy regardless of treatment dosage, prior treatment history, and PD-L1 expression. This data was based on a median follow-up of 10.4 months (as of October 5, 2022). Furthermore, updated data from the study (with a median follow-up of 19.3 months) as of June 30, 2023 demonstrates the increased safety and survival benefits of ivonescimab monotherapy.
Currently, following an acceptance of the marketing application with priority review of ivonescimab by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA), four 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 clinical trials.
About Ivonescimab (PD-1/VEGF bispecific antibody)
Ivonescimab is a potential first-in-class investigational PD-1/VEGF bi-specific antibody discovered by Akeso and is believed to be the PD-1 / VEGF bispecific antibody that is most advanced in the clinic. It combines the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. Ivonescimab is currently engaged in multiple Phase III clinical trials worldwide.
In December 2022, Akeso entered into a collaboration and license agreement for up to US$5 billion with Summit Therapeutics ("Summit"). Akeso out-licensed to Summit exclusive rights to ivonescimab (PD-1/VEGF) for the development and commercialization in the United States, Canada, Europe, and Japan. Akeso will retain development and commercialization rights for the rest of the world including China. Ivonescimab is known as AK112 for Akeso’ R&D code at China and Australia, and as SMT112 for Summit’s license territories.