Dr Rugo on QOL Data From SERENA-6 in ER+/HER2– Advanced Breast Cancer

“Camizestrant isn’t an [FDA]-approved drug yet and this approach isn’t approved yet. We’re waiting to hear from the regulatory reviewers, but I assume this approach to treatment will be approved in less than a year.”

Hope S. Rugo, MD, a professor in the Department of Medical Oncology & Therapeutics Research, division chief of Breast Medical Oncology, and director of the Women’s Cancers Program at City of Hope, discussed quality of life (QOL) data from the phase 3 SERENA-6 study (NCT04964934).

During the 2025 ASCO Annual Meeting, investigators presented QOL findings from SERENA-6 which showed that patients with estrogen receptor (ER)–positive, HER2-negative advanced breast cancer who received camizestrant plus a CDK4/6 inhibitor (n = 157) had a median time to deterioration (TTD) of 23.0 months (95% CI, 13.8-not calculable) compared with 6.4 months (95% CI, 2.8-14.0) among patients who received an aromatase inhibitor (AI) plus a CDK4/6 inhibitor. This translated to an adjusted HR for TTD of 0.53 (95% CI, 0.33-0.82; nominal P < .001). QOL was assessed by the European Organization for Research and Treatment of Cancer 30-item QOL questionnaire (EORTC QLQ-C30).

The QOL data from SERENA-6 were significant because they demonstrated that changing therapy from an AI to camizestrant in the presence of an ESR1 mutation could lead to less pain for patients, Rugo said. It is unknown why patient QOL was significantly worse in the control arm even though the median progression-free survival was 9.2 months (95% CI, 7.2-9.5), she added. This could indicate that metastatic breast cancer in this patient population may not be well detected via scans, she noted.

Rugo emphasized that the EORTC QLQ-30 domains were not reported during the presentation at ASCO. These will hopefully be reported during the upcoming ESMO Congress 2025 and will be important for understanding the application of the SERENA-6 regimen to clinical practice, she said. Camizestrant nor the SERENA-6 treatment approach are approved by the FDA, but they could win approval in less than a year, Rugo concluded.