anastrozole + nivolumab + palbociclib

Anastrozole + nivolumab + palbociclib is an investigational neoadjuvant combination regimen evaluated for the treatment of estrogen receptor-positive (ER+), HER2-negative (HER2−) primary breast cancer. The regimen consists of three distinct therapeutic agents: **nivolumab**, a fully human IgG4 monoclonal antibody that acts as an immune checkpoint inhibitor by targeting the PD-1 receptor; **palbociclib**, an orally active small-molecule inhibitor of cyclin-dependent kinases 4 and 6 (CDK4/6); and **anastrozole**, a nonsteroidal aromatase inhibitor that blocks the conversion of androgens to estrogens. Developed by Bristol Myers Squibb, the combination was studied in the Phase 1b/2 CheckMate 7A8 trial (NCT04075604) based on preclinical evidence suggesting synergistic anti-tumor activity between PD-1 blockade and CDK4/6 inhibition. However, the study was terminated early during the safety run-in phase due to a high incidence of grade 3/4 hepatotoxicity and significant treatment discontinuation, leading to the conclusion that the triplet is not suitable for further development in this clinical setting.

Other names

nivolumab + palbociclib + anastrozole