AstraZeneca’s Phase III SERENA-4 trial of Etcamah, or camizestrant, combined with palbociclib failed to show a statistically significant improvement in progression-free survival for patients receiving first-line treatment for advanced ER-positive, HER2-negative breast cancer.
The randomized, double-blind trial compared once-daily camizestrant plus the CDK4/6 inhibitor palbociclib with anastrozole, an aromatase inhibitor, plus palbociclib. AstraZeneca said the Etcamah regimen produced a numerical improvement in progression-free survival but did not meet the study’s primary objective.
SERENA-4 enrolled 1,371 adults with locally advanced or metastatic disease who had not previously received systemic treatment for advanced breast cancer. Participants included patients newly diagnosed with Stage IV disease and those with recurrent disease.
The company did not provide numerical progression-free-survival results, hazard ratios, confidence intervals or secondary-endpoint data. Secondary endpoints include overall survival, time to second progression and health-related quality of life. AstraZeneca said data from the study will be shared at a later date.
The safety profile of camizestrant plus palbociclib was consistent with the known safety profiles of the two medicines, and no new safety concerns were identified, according to the company.
Camizestrant is an oral selective estrogen receptor degrader, or SERD, and estrogen receptor antagonist. It is administered at a recommended dose of 75 mg once daily when used with a CDK4/6 inhibitor.
Etcamah is already approved in the United States, European Union, Japan and several other markets for HR-positive or ER-positive, HER2-negative locally advanced or metastatic breast cancer when an ESR1 mutation is detected or emerges during first-line endocrine-based therapy. Those approvals were based on the Phase III SERENA-6 trial.
AstraZeneca continues to study Etcamah in the Phase III CAMBRIA-1 and CAMBRIA-2 trials in early breast cancer.
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