Positive Phase III results for AstraZeneca’s camizestrant

26 February 2025

Positive high-level results from a planned interim analysis of the SERENA-6 Phase III trial showed that AstraZeneca’s (LSE: AZN) camizestrant in combination with a cyclin-dependent kinase (CDK) 4/6 inhibitor (palbociclib, ribociclib or abemaciclib) demonstrated a highly statistically-significant and clinically-meaningful improvement in the primary endpoint of progression-free survival (PFS).

The trial evaluated switching to the camizestrant combination versus continuing standard-of-care treatment with an aromatase inhibitor (AI) (anastrozole or letrozole) in combination with a CDK4/6 inhibitor in the 1st-line treatment of patients with hormone receptor (HR)-positive, HER2-negative advanced breast cancer whose tumors have an emergent ESR1 mutation.

The Cambridge, UK-based pharma major said the SERENA-6 trial showed that switching to camizestrant in combination with a cyclin-dependent kinase 4/6 inhibitor after the emergence of an ESR1 mutation led to a statistically-significant and clinically-meaningful improvement in progression-free survival, compared with continuing treatment with an aromatase inhibitor and a CDK4/6 inhibitor.

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