Shots:
AZ's trial assessed camizestrant (n=157) vs AI (anastrozole/letrozole; n=158), both in combination with CDK4/6 inhibitor in 315 pts with LA/M HR+/HER2- advanced breast cancer harboring ESR1 mutation; filings supported by the trial are under review in the US, EU & Japan
Trial showed 24mos. PFS rate of 34.9% vs 14.2% (mPFS: 16.8 vs…
Shots:
The CHMP has recommended AZ's Camizestrant + a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib) for adults with ER+, HER2- locally advanced or metastatic breast cancer with an ESR1 mutation & no progression on 1L endocrine therapy + CDK4/6 inhibitor; regulatory review is ongoing in the US & Japan
Opinion was based on the P-III…
Shots:
The P-III (SERENA-6) trial assessed camizestrant + CDK4/6 inhibitor (palbociclib/ribociclib/abemaciclib) vs AI (anastrozole/letrozole) + CDK4/6 inhibitor in 315 pts with LA/M HR+/HER2- breast cancer harboring ESR1 mutation
SERENA-6 used ctDNA-guided approach to monitor ESR1 mutations at routine scans for the early detection of endocrine resistance, allowing pts to switch to camizestrant before disease…

