On June 4, 2017 Radius Health, Inc. (Nasdaq:RDUS), a fully integrated science-driven biopharmaceutical company that is committed to developing innovative therapeutics in the areas of osteoporosis, oncology and endocrine diseases, reported positive data from a fully enrolled ongoing Phase 1 study of elacestrant (RAD1901), an oral selective estrogen receptor degrader (SERD), in patients with estrogen receptor positive (ER+) breast cancer (Press release, Radius, JUN 4, 2017, View Source [SID1234519414]). These data were presented this morning at the 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Meeting in Chicago, Illinois. Schedule your 30 min Free 1stOncology Demo! As of the cut-off date of April 28, 2017, 40 patients have been treated in the fully enrolled elacestrant Phase I dose escalation and expansion cohorts at the 400 mg dose. These patients are all heavily pretreated ER+, HER2-negative advanced breast cancer patients who have received a median of 3 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 five confirmed partial responses in this group. Elacestrant was well-tolerated with the most common adverse events being low grade nausea and dyspepsia.
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"While still early, the single-agent clinical activity and safety profile demonstrated with elacestrant in this heavily pretreated advanced hormone receptor positive breast cancer patient population is encouraging when compared to the results shown for other agents in a similar setting," said 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. "This is important for patients because it could potentially offer another endocrine therapy option even upon progression on standard endocrine therapy and could potentially delay the use of toxic chemotherapy, which is a meaningful clinical goal, and additional studies are needed."
On June 4, 2017, at the 2017 ASCO (Free ASCO Whitepaper) Annual Meeting, the following abstract was presented as a poster and will be included in the Poster Discussion Session later today: Abstract 1014
"Evaluation of Elacestrant (RAD1901), a novel investigational, selective estrogen receptor degrader (SERD), for the treatment of ER-positive (ER+) advanced breast cancer" Abstract 1014, 8:00 AM – 11:30 AM, Hall A, Poster Board #6, POSTER SESSION, Breast Cancer-Metastatic
Discussed at the Poster Discussion Session, 4:45 PM – 6:00 PM, Hall B1, Aditya Bardia, MD, MPH – First Author, Massachusetts General Hospital Cancer Center and Harvard Medical School
About Elacestrant (RAD1901)
Elacestrant is a selective estrogen receptor down-regulator/degrader (SERD), which at high doses is being evaluated for potential use as an oral non-steroidal treatment for estrogen receptor positive breast cancer, the most common form of the disease. Studies completed to date indicate that the compound has the potential for use as a single agent or in combination with other therapies for the treatment of breast cancer.
Additional information on the clinical trial program of elacestrant (RAD1901) is available on www.clinicaltrials.gov.
About RAD140
RAD140 is a non-steroidal selective androgen receptor modulator (SARM). The androgen receptor (AR) is frequently expressed in many estrogen receptor (ER)-positive, ER-negative, and triple-negative breast cancers. Because of its receptor and tissue selectivity, potent activity, oral bioavailability, and long half-life, RAD140 could have clinical potential in the treatment of breast cancer. RAD140 resulted from an internal drug discovery program focused on the androgen receptor pathway, and exhibits a differentiated mechanism of action compared to ER-targeted therapy.