Akeso 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 naive 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). The principal investigator of this study is Prof. Caicun Zhou, MD, PhD, from Shanghai Pulmonary Hospital, affiliated with Tongji University. 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) meeting.

From the data published in JTO, patients with advanced or metastatic NSCLC can benefit from ivonescimab mon 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.