Positive Phase III results for Menarini's elacestrant

Additional data from the Phase III EMERALD study (NCT03778931) of elacestrant, an investigational oral selective estrogen receptor degrader (SERD), are being presented during the San Antonio Breast Cancer Symposium (SABCS) being held from December 6-10.

The potential breast cancer therapeutic is under development by privately-held Italian drugmaker Menarini and its wholly-owned subsidiary Stemline Therapeutics. They released top-line data showing that a post-hoc analysis of the PFS results in the EMERALD trial based on the duration of prior CDK4/6i usage shows clinically-meaningful results which favor monotherapy elacestrant, both in the total patient population as well as in patients with ESR1-mut. Increased duration of prior CDK4/6i in metastatic patients was positively associated with longer PFS on elacestrant but not with SOC.

For those who were exposed to CDK4/6i ≥12 months prior to randomization on EMERALD, elacestrant achieved: