Biopharmaceutical major AstraZeneca has said its Phase III SERENA-4 trial evaluating Etcamah (camizestrant) in combination with palbociclib did not meet its objective of statistically significant improvement in progression-free survival in patients with advanced breast cancer.
However, a numerical improvement was observed in the first-line treatment of patients with estrogen receptor (ER)-positive, HER2-negative advanced breast cancer who had not received any systemic treatment for advanced disease, the company said in a statement.
The SERENA-4 trial evaluated the Etcamah and palbociclib combination versus an aromatase inhibitor (anastrozole) combined with palbociclib. Palbociclib is a cyclin-dependent kinase (CDK) 4/6 inhibitor.
Regarding the drug's safety, the company noted that the safety profile of Etcamah in combination with palbociclib was consistent with the known profiles of each medicine, with no new safety concerns identified.
"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," said Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca.
Galbraith added that early breast cancer represents an important opportunity, and the company remains confident in the long-term potential of the drug.
AstraZeneca stated that Etcamah is also currently being evaluated in early breast cancer through the CAMBRIA-1 and CAMBRIA-2 Phase III trials, encompassing approximately 10,000 patients at intermediate and high risk of recurrence in the adjuvant setting.
