AstraZeneca (LSE:AZN) said its Phase III SERENA-4 trial evaluating Etcamah, or camizestrant, in combination with palbociclib did not meet its primary endpoint in patients with ER-positive, HER2-negative advanced breast cancer.
The trial assessed Etcamah plus the CDK4/6 inhibitor palbociclib as a first-line treatment against anastrozole plus palbociclib.
AstraZeneca said the Etcamah combination showed a numerical improvement in progression-free survival compared with the anastrozole regimen, but the difference was not statistically significant.
Safety Profile Consistent With Existing Data
According to the company, the safety profile observed with Etcamah and palbociclib was consistent with existing data for the treatments.
The SERENA-4 result does not affect Etcamah’s currently approved use in patients with ESR1-mutated disease, which is based on findings from the SERENA-6 programme.
Early Breast Cancer Trials Continue
AstraZeneca said it will focus on the currently approved use of Etcamah in ESR1-mutated disease while continuing its clinical development programme for the drug.
This includes the CAMBRIA-1 and CAMBRIA-2 trials, which are evaluating Etcamah in early breast cancer.
AstraZeneca is a Cambridge, UK-headquartered biopharmaceutical company developing and commercialising prescription medicines across oncology, rare diseases and other biopharmaceutical areas, including cardiovascular, renal, metabolism, respiratory and immunology. Its medicines are sold in more than 125 countries.
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