The FDA has granted breakthrough therapy designation to BNT323/DB-1303, a HER2-targeted antibody-drug conjugate (ADC), for treating patients with advanced endometrial cancer who are unresponsive to immune checkpoint inhibitors. This decision follows phase 1/2 trial results showing a 58.8% overall response rate and 94.1% disease control rate in 17 patients. Developed by DualityBio, this ADC has been effective in various HER2-positive and low tumors, including breast and gastric cancers.
BioNTech’s Chief Medical Officer emphasized the potential of ADC in addressing the significant medical need for advanced HER2-expressing endometrial cancer treatments. The ongoing trial aims to determine the maximum tolerated dose and assess safety and efficacy, with primary endpoints including treatment-emergent adverse effects and overall response rate. A phase 3 trial is also underway for HER2-low metastatic breast cancer.
Reference: Wahner A. FDA Grants Breakthrough Therapy Designation to BNT323/DB-1303 in Endometrial Cancer. OncLive. Updated December 21, 2023. Accessed February 2, 2024. https://www.onclive.com/view/fda-grants-breakthrough-therapy-designation-to-bnt323-db-1303-in-endometrial-cancer
