China-based Alphamab Oncology (HKG: 9966) and CSPC Pharmaceutical Group Ltd (HKG: 1093) have announced the publication of Phase II clinical study data for KN026 as a second-line treatment for HER2-positive locally advanced unresectable or metastatic gastric cancer or gastroesophageal junction cancer (GC/GEJ) in the European Journal of Cancer (IF=10.002). The study demonstrated that KN026 has excellent efficacy and good safety in patients with HER2-positive GC/GEJ.
Study Details and Results
The study enrolled 45 patients with GC/GEJ who had received at least a first-line treatment in the past. Among them, 27 patients with high HER2 expression received KN026 at doses of 10mg/kg QW (5 cases), 20mg/kg Q2W (4 cases), and 30mg/kg Q3W (18 cases). Twenty-five patients had received at least one tumor imaging evaluation, of which 14 patients were evaluated as partial remission (PR), 5 patients as stable disease (SD), 5 patients as progressive disease (PD), and 1 patient could not be evaluated. The objective response rate (ORR) was as high as 56%, with long-term disease response achievable. The median duration of response (DOR) was 9.7 months, and the median progression-free survival (PFS) and overall survival (OS) were 8.3 months and 16.3 months, respectively. For the 14 patients who had been treated with trastuzumab before and progressed, there was still an excellent therapeutic effect.
Safety Profile
All 45 patients were included in the safety analysis. The common drug-related adverse events (TRAE) were elevated AST (27%), elevated ALT (20%), rash (16%), anemia (16%), and infusion-related reactions (16%). The major adverse events were mild to moderate (CTCAE 1-2). Only 4 patients (8.9%) had CTCAE Level 3 TRAE, and no patients had CTCAE Level 4 or death-related TRAE. The results show that KN026 has excellent efficacy and good safety in patients with HER2-positive GC/GEJ.
KN026 Profile
KN026 is a potential next-generation HER2-targeted therapy that simultaneously combines two HER2 epitopes to enhance the killing effect on tumor cells. It has obtained umbrella IND approval in China and IND approval in the US, with multiple Phase I/II studies underway. KN026 has produced a good preliminary efficacy profile in advanced HER2 highly-expressed breast cancer, gastric cancer, and gastroesophageal junction cancer. In August last year, CSPC Pharma subsidiary Shanghai JMT Biotechnology Co., Ltd struck a licensing deal with Alphamab, taking exclusive development and commercialization rights to KN026 combined with KN046, a bispecific antibody targeting both programmed cell death-1 (PD-1) and cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), in mainland China, where it would become the marketing authorization holder (MAH) for KN026.-Fineline Info & Tech
