LONDON (dpa-AFX) - AstraZeneca plc (AZN, AZN.L), on Wednesday, reported positive high-level results from a planned interim analysis of the SERENA-6 Phase III trial of Of Camizestrant.
The company stated that the planned interim analysis results showed that camizestrant in combination with a cyclin-dependent kinase or CDK 4/6 inhibitor demonstrated a highly statistically significant and clinically meaningful improvement in the primary endpoint of progression-free survival or 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 tumours have an emergent ESR1 mutation.
The key secondary endpoints of time to second disease progression (PFS2) and overall survival (OS) were immature at the time of this interim analysis. However, the camizestrant combination demonstrated a trend toward improvement in PFS2. The trial will continue as planned to further assess key secondary endpoints.
SERENA-6 represents the first global, double-blind, registrational Phase III trial employing a circulating tumor DNA (ctDNA)-guided methodology to identify the emergence of endocrine resistance and to facilitate a change in therapeutic strategy prior to disease progression.
The safety profile of camizestrant in conjunction with palbociclib, ribociclib, or abemaciclib in the SERENA-6 trial was consistent with the established safety profiles of each respective medication. No new safety concerns were raised, and the rates of treatment discontinuation were minimal and comparable across both study arms. Data will be presented at an upcoming medical meeting and subsequently communicated to global regulatory authorities, the company noted.
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