Giuseppe Curigliano, MD, PhD, on Patient-Reported Outcomes From EMBER-3

The EMBER-3 was a prospective randomized trial comparing a standard of care that is endocrine therapy versus imlunestrant and imlunestrant alone versus imlunestrant plus abemaciclib. The primary endpoint was median progression-free survival and according to the data that will be presented, imlunestrant alone was better than standard of care endocrine therapy in the patient population with ESR1 mutation. The secondary endpoint of the study was to compare imlunestrant to imlunestrant plus abemaciclib and the addition of abemaciclib improved median progression-free survival versus imlunestrant. What we are going to present during ASCO is the secondary endpoint: patient-reported outcomes and quality of life. We assessed global health status and quality of life in patients receiving imlunestrant alone, endocrine therapy standard of care, and imlunestrant plus abemaciclib. According to the results of the study, the quality of life and the global health status of the patient population receiving abemaciclib plus imlunestrant was exactly very similar to the standard arm imlunestrant alone. Also, when we compare imlunestrant to standard of care, we have a similar quality of life and similar patient-reported outcome. Maybe the most interesting finding of the study was the injection site reaction, because the patients in the standard of care arm received fulvestrant and many of the patients in the patient-reported outcome complained about injection site reaction. We have also to report the data on diarrhea that was more frequent in the arm imlunestrant plus abemaciclib versus imlunestrant alone even if data are almost similar to the standard of care actually the fulvestrant plus abemaciclib. So in conclusion, the data on patient-reported outcome from EMBER-3 confirm that quality of life and global health status was not so different with respect to standard of care. We have also to report that injection site reaction derived from fulvestrant administration was a major issue for almost all patients. So we confirm that imlunestrant alone is better than standard of care in ESR1-mutant population, and that the combination of imlunestrant plus abemaciclib is a new standard of care in patients with HR-positive, HER2-negative disease without affecting global health status and quality of life.