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AZN:Camizestrant Delayed Disease Progression In Advanced ER-Positive Breast Cancer In Phase II Trial

AstraZeneca (AZN) said results from the SERENA-2 Phase II trial showed that its next-generation oral selective estrogen receptor degrader (ngSERD) camizestrant demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) at both 75mg and 150mg dose levels versus FASLODEX (fulvestrant) 500mg in post-menopausal patients with estrogen receptor (ER)-positive locally advanced or metastatic breast cancer, previously treated with endocrine therapy.

In the overall population, camizestrant significantly reduced the risk of disease progression or death by 42% at a 75mg dose and 33% at a 150mg dose compared to FASLODEX, the current SERD standard of care.

Among the prespecified subgroup of patients with ESR1 mutations - comprising 36.7% of the trial population - camizestrant showed a 67% reduction in the risk of disease progression or death at a 75mg dose and a 45% reduction at a 150mg dose compared to FASLODEX.

Efficacy was also seen in patients without a detectable ESR1 mutation, with a 22% and 24% reduction in the risk of disease progression or death respectively for the 75mg and 150mg dose levels.

A clinically meaningful PFS benefit was also observed across other prespecified subgroups, including in patients with previously treated with prior cyclin-dependent kinase (CDK) 4/6 inhibitors, those with lung and/or liver metastases and those with ER-driven disease.

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