François-Clément Bidard, Head of Center for Clinical Investigation, Inserm CIC-1428 at Inserm, shared a post on LinkedIn:
“New data from SERENA-6 !
A mini-oral that I presented at SABCS ’25, reporting the 2nd data cut-off.
SERENA-6 is this well-known cutting-edge registrational trial, built on PADA-1, offering an ESR1m-guided treatment switch to camizestrant (+maintained CDK4/6i) during 1st line therapy for ER+ HER2- mBC, ahead of disease progression.
In short:
- PFS benefit is clearly confirmed (the delta in mPFS being expanded to +7.4mo)
- PFS2 shows the gain is conserved to the next line of treatment (+6 mo delta, not yet reaching stat. significance, but the 84% information fraction tells we are are in a home run)
- Time to first and second subsequent treatments are aligned with PFS and PFS2, with striking hazard ratios.
- Most importantly (and new !), chemo-free survival was reported for the 1st time and reached stat. sig. (delta in mCFS= 4 months). This was a much awaited secondary endpoint, supporting the use of camizestrant ahead of disease progression.
At the molecular level, ESR1m ctDNA changes during treatment substantiate the efficacy of camizestrant in this setting.
All these metrics support the adoption of ESR1m interception, and entering into a new era of *truly* adaptive therapy in metastatic breast cancer.”
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