China-based Akeso Biopharma (HKG: 9926) has announced that its Phase III AK104-303 study for cadonilimab (AK104), an innovative bispecific antibody targeting programmed death-1 (PD-1) and cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), has achieved its primary endpoint. The study combines the antibody with chemotherapy and optional bevacizumab for the first-line treatment of persistent, recurrent, or metastatic cervical cancer. An independent committee assessed the results based on RECIST v1.1 criteria for progression-free survival (PFS), with the treatment showing consistent safety in line with previous clinical research, and no new safety signals were detected.
Cadonilimab’s Approval and Ongoing Studies
Cadonilimab received conditional approval in China in June 2022 for the treatment of patients with recurrent or metastatic cervical cancer who had previously failed platinum-based chemotherapy. Clinical research data indicates that the combination therapy of cadonilimab with a CTLA-4 monoclonal antibody significantly reduces toxicity and offers substantial safety and efficacy benefits. Additionally, a regulatory Phase III clinical study for the drug in combination with chemotherapy for first-line advanced adenocarcinoma of the stomach or gastroesophageal junction has also met its primary endpoint in interim analysis.
Collaboration with Remegen on Gastric Cancer Treatment
Akeso Biopharma is also collaborating with fellow Chinese firm Remegen (HKG: 9995) to assess the combination of Remegen’s antibody-drug conjugate (ADC) candidate disitamab vedotin (RC48) with cadonilimab for the treatment of gastric cancer.- Flcube.com
