Etcamah combination misses primary endpoint in Phase III SERENA 4 breast cancer trial

AstraZeneca has reported that the Phase III SERENA 4 trial of Etcamah, also known as camizestrant, in combination with palbociclib did not meet its primary endpoint in patients receiving upfront first line treatment for advanced estrogen receptor positive, HER2 negative breast cancer.

The study did not demonstrate a statistically significant improvement in progression free survival, although AstraZeneca said a numerical improvement was observed.

SERENA 4 evaluated Etcamah alongside palbociclib, a cyclin dependent kinase 4 and 6 inhibitor, in patients who had not previously received systemic treatment for advanced disease.

The combination was compared with the aromatase inhibitor anastrozole given together with palbociclib.

Susan Galbraith, Executive Vice President of Oncology Haematology Research and Development at AstraZeneca, said the company was disappointed with the outcome of SERENA 4 but that the findings increased its focus on ensuring eligible patients can benefit from Etcamah on the basis of the SERENA 6 results.

She also highlighted the importance of ESR1 mutation testing for patients receiving first line treatment and said AstraZeneca remains confident in the longer term potential of Etcamah in early breast cancer.

No new safety concerns were identified during SERENA 4. AstraZeneca said the safety profile of Etcamah in combination with palbociclib remained consistent with the established profiles of the individual medicines.

Full results from the trial are expected to be presented at a later date.

Etcamah has already demonstrated benefit in a different first line treatment setting through the Phase III SERENA 6 study.

Based on those findings, Etcamah in combination with a CDK4/6 inhibitor, including palbociclib, ribociclib or abemaciclib, is approved in the US, European Union, Japan and several other markets.

Those approvals cover adults with hormone receptor positive or estrogen receptor positive, HER2 negative locally advanced or metastatic breast cancer when an ESR1 mutation is detected or emerges during first line endocrine based treatment.

AstraZeneca is also continuing to investigate Etcamah across an extensive clinical development programme in early breast cancer.

The Phase III CAMBRIA 1 and CAMBRIA 2 studies together involve approximately 10,000 patients at intermediate or high risk of recurrence.

The trials are evaluating Etcamah in several treatment approaches, including as a monotherapy, alongside CDK4/6 inhibitors and following treatment with a CDK4/6 inhibitor, with the aim of addressing remaining treatment needs in hormone receptor positive, HER2 negative early breast cancer.

---

---

Related Topics and Keywords

astrazenca, breast cancer, camizestrant, Cancer, cancer research, clinical trial, Etcamah, Oncology, pharma news, SERENA4, SERENA6