Chinese pharmaceutical company Akeso Inc (HK:9926) announced on Wednesday that the first patient has been enrolled in the pivotal/registration Phase III clinical trial (AK112-310/HARMONi-GI2) of ivonescimab, a first-in-class PD-1/VEGF bispecific antibody developed by the company.
The trial is investigating ivonescimab in combination with chemotherapy, with or without ligufalimab (CD47 monoclonal antibody), for the first-line treatment of metastatic pancreatic cancer.
The company says that ivonescimab, in combination with chemotherapy and/or ligufalimab, has the potential to address the current lack of effective options in first-line immunotherapy for metastatic pancreatic cancer. This randomised, controlled, multi-centre Phase III trial is a key component of Akeso's broader strategy to address the significant unmet clinical needs in global oncology. The combination of ivonescimab with ligufalimab is expected to synergistically enhance anti-tumour activity, offering a potential breakthrough in the first-line treatment for metastatic pancreatic cancer.
Professor Yu Xianjun, director of Fudan University Shanghai Cancer Center, Professor Ying Jie'er from Zhejiang Cancer Hospital, and Professor Tai Sheng from Harbin Medical University Cancer Hospital are the co-principal investigators for the HARMONi-GI2 study.
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