AstraZeneca's camizestrant fails primary endpoint in breast cancer trial
AstraZeneca's (NASDAQ: AZN) camizestrant (Etcamah) did not meet its primary endpoint of progression-free survival (PFS) in the SERENA-4 Phase III trial, the company announced.
The trial evaluated camizestrant in combination with palbociclib versus an aromatase inhibitor (anastrozole) combined with palbociclib in the first-line treatment of patients with estrogen receptor (ER)-positive, HER2-negative advanced breast cancer who had not received prior systemic treatment for advanced disease. A numerical improvement in PFS was observed, though the primary endpoint was not met.
Susan Galbraith, Executive Vice President, Oncology Haematology R&D at AstraZeneca, said: "Whilst we are disappointed by the SERENA-4 outcome, it sharpens our focus on maximising the number of patients who can benefit from Etcamah today based on SERENA-6 and reinforces the importance of ESR1 testing for patients on first-line therapy."
The safety profile of camizestrant in combination with palbociclib was consistent with the known profiles of each medicine, with no new safety concerns identified. Full data are expected to be shared at a future date.
Camizestrant in combination with a CDK4/6 inhibitor is currently approved in the U.S., EU, Japan, and several other countries for HR-positive, HER2-negative locally advanced or metastatic breast cancer upon detection of an ESR1 mutation during first-line endocrine-based therapy, based on results from the SERENA-6 trial.
AstraZeneca is also evaluating camizestrant in the CAMBRIA-1 and CAMBRIA-2 Phase III trials, which together enroll approximately 10,000 patients in the adjuvant setting for HR-positive, HER2-negative early breast cancer.