-Elacestrant 400mg single agent Objective Response Rate (ORR) was 27.3% in heavily pre-treated patients with advanced ER+ breast cancer at the pre-determined study cutoff date of October 30, 2017-
-Median PFS was 5.4 months and Clinical Benefit Rate at 24 weeks was 47.4% –
-38% of study patients previously received fulvestrant; 40% received palbociclib or other CDK 4/6 inhibitor; 50% had an ESR1 mutation-
-10 of the 40 patients remain on treatment as of the cutoff date-
-Investor Webcast today at 8:00 pm CT-
WALTHAM, Mass., Dec. 07, 2017 (GLOBE NEWSWIRE) — Radius Health, Inc. (NASDAQ:RDUS) today provided an update on data from the Phase 1 005 clinical study of elacestrant (RAD1901), an oral selective estrogen receptor degrader (SERD), in patients with estrogen receptor positive (ER+) breast cancer. The data were presented at a Spotlight Presentation (Abstract 1410) during the 2017 San Antonio Breast Cancer Symposium (SABCS). Elacestrant recently received Fast Track designation from the U.S. Food and Drug Administration.
There are 40 patients that have been treated at the 400 mg dose in the elacestrant Phase I dose escalation and expansion cohorts. All study participants are heavily pretreated ER+, HER2-negative, advanced breast cancer patients that have received a median of three prior lines of systemic therapy and have evaluable advanced or metastatic disease. Of the enrolled patients, 22 patients met the RECIST measurable disease criteria at baseline and there were 6 confirmed partial responses in this group. Elacestrant was well-tolerated with the most common adverse events being low grade nausea, dyspepsia and vomiting.
“It is quite encouraging to see the clinical activity with elacestrant in the heavily pretreated advanced patient population, and further therapeutic development is warranted for patients with hormone receptor positive breast cancer”, commented Dr. Aditya Bardia, Director of Precision Medicine and attending physician at Center for Breast Cancer, Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston, MA.
Radius plans to initiate a Phase 2 clinical study of elacestrant monotherapy, a potentially pivotal study, for women with advanced or metastatic ER+/HER2- breast cancer early in 2018.
“Patients cycle through and generally do not repeat treatment regimens, limiting treatment options as their disease advances. We are pleased about the potential to offer patients who have progressed or relapsed during their current standard of care with a new treatment option,” said Gary Hattersley, PhD, Chief Scientific Officer. “Radius is committed to developing and to providing breast cancer patients with the next generation of hormonal treatment options, as a single …