China-based Alphamab Oncology (HKG: 9966) announced the first patient dosing in the multi-center, open-label Phase II KN046-209 study. The trial evaluates the efficacy, safety, and tolerability of KN046 (erfonrilimab) combined with axitinib in first-line locally advanced or metastatic PD-L1-positive (TPS ≥ 1%) non-small cell lung cancer (NSCLC) patients who have not previously received systemic therapy. The study, which plans to enroll 54 subjects, has set the objective response rate (ORR) as its primary endpoint.
Drug Background
KN046 is a bispecific antibody (BsAb) targeting both programmed cell death-1 (PD-1) and cytotoxic T-lymphocyte-associated protein 4 (CTLA-4). The drug is currently involved in nearly 20 clinical studies across various cancers, including NSCLC, triple-negative breast cancer, esophageal squamous cell carcinoma, hepatocellular carcinoma, pancreatic ductal adenocarcinoma (PDAC), thymic carcinoma, and others. Preliminary results from these studies have been positive.
Axitinib Background
Inlyta (axitinib), a next-generation tyrosine kinase inhibitor (TKI) developed by US pharmaceutical giant Pfizer, was first approved in the US, Japan, and the European Union (EU) in 2012. The drug received market approval in China in April 2015 for the treatment of advanced renal cell carcinoma (RCC).-Fineline Info & Tech
