Breast Cancer competitive landscape

Notable developments include: 

• HER2-expressing
  • AstraZeneca and Daiichi Sankyo announced that the FDA granted priority review for T-DXd for the treatment of HER2-low (IHC 1+ or IHC2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining) mBC after at least one ET in the metastatic setting with a PDUFA date set to Feb 1, 2025. 
  • Daiichi Sankyo also submitted an sNDA to Japan’s Ministry of Health, Labour and Welfare (MHLW) for T-DXd for HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining) unresectable or recurrent BC. No mention of prior ET or HR-status was made in the proposed indication.  
  • AstraZeneca and Daiichi Sankyo launched a new TV commercial for T-DXd (Enhertu, HER2-ADC) in line with its new black and white branding design and slogan “Sure, metastatic breast cancer will try to take it all. But Not Today”

• HR+/HER2-
  • Roche announced the FDA approval of inavolisib (Itovebi, PI3Kα inhibitor)  + palbociclib (Ibrance; CDK 4/6 inhibitor) + fulvestrant (SERD) for the treatment of PIK3CAmut HR+/HER2- mBC following recurrence or after completing adjuvant ET

• TNBC
  • Kelun announced updated data from the Phase 3 OptiTROP-Breast01 trial evaluating sacituzumab tirumotecan (sac-TMT, TROP2 ADC) in 3L+ TNBC presented at the China Clinical Oncology Congress (CSCO) 2024 continued to show statistically and clinically meaningful improvements in PFS and OS, with a manageable safety profile