Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) has announced that another indication approval filing for its anti-HER2 antibody drug conjugate (ADC), trastuzumab botidotin (A166), has been accepted for review by the Center for Drug Evaluation of the National Medical Products Administration (NMPA). The Chinese company is seeking approval for the drug’s use in adult patients with HER2-positive unresectable or metastatic breast cancer who have received at least one anti-HER2 treatment in the past.
Study and Results
Kelun-Biotech leveraged results from the KL166-III-06 study for the filing. This multi-center, randomized, open, controlled Phase III study assessed the efficacy and safety of trastuzumab botidotin versus trastuzumab emtansine (T-DM1) in patients with HER2-positive unresectable or metastatic breast cancer previously treated with trastuzumab and taxanes. According to the predetermined mid-term analysis, trastuzumab botidotin showed significant statistical and clinical improvement in progression-free survival (PFS) compared to T-DM1, as assessed by Blinded Independent Central Review (BICR), the primary endpoint.
Innovation and Regulatory Status
Trastuzumab botidotin is the world’s first third-generation anti-HER2 ADC with lysine fixed-point quantitative coupling, innovative linkers, and a highly active toxin. The drug is also awaiting regulatory decisions in China, with a filing for the treatment of HER2-positive locally advanced, recurrent, or metastatic breast cancer after previous second-line or higher anti-HER2 treatment failure accepted for review by the NMPA in May 2023.
Significance of the Filing
The acceptance of the filing for expanded indications highlights Kelun-Biotech’s commitment to advancing innovative treatments for HER2-positive breast cancer. This development could potentially offer new treatment options for patients who have limited options after receiving prior anti-HER2 therapies.-Fineline Info & Tech
