Camizestrant with three CDK4/6 inhibitors in advanced breast cancer

New data from the phase 1 SERENA-1 trial, recently published on Clinical Cancer Research, shows a well-tolerated safety profile, no clinically meaningful drug–drug  interactions and encouraging clinical activity for camizestrant in association with CDK4/6 inhibitors in ER+/HER2- advanced breast cancer patients.

Camizestrant, the next generation oral SERD and complete estrogen receptor antagonist, is in phase 3 development for the treatment of ER+/HER2- breast cancer, as monotherapy and in combination with CDK4/6 inhibitors; the new open-label SERENA-1 trial investigated the effect of camizestrant in combination with abemaciclib, palbociclib or ribociclib on 191 patients with refractory ER+, HER2− advanced breast cancer and a median of 2 prior regimens for advanced disease. In this heavily pretreated population, the median progression-free survival was 7,4 months with anti-tumor activity across all combinations, including patients previously treated with CDK4/6 inhibitors and/or fulvestrant. No clinically meaningful drug–drug interactions were seen and adverse events were consistent with drug profile. As authors conclude «The patient population in this study had  received extensive lines of prior therapy, including CDK4/6 inhibitors, fulvestrant, and chemotherapies, and there was no selection for endocrine sensitivity. Despite this, encouraging clinical activity was observed for camizestrant in combination with each CDK4/6 inhibitors, with no evidence of clinically relevant drug–drug interactions».