The Menarini Group (“Menarini”), a number one worldwide pharmaceutical and diagnostics firm, and Stemline Therapeutics, Inc. (“Stemline”), a wholly-owned subsidiary of the Menarini Group, centered on bringing transformational oncology remedies to most cancers sufferers, offered outcomes from section 1b/2 ELEVATE and ELECTRA medical research evaluating ORSERDU® (elacestrant) together with different remedies. Each the ELEVATE and ELECTRA research have been designed with the target to beat totally different resistance mechanisms and improve affected person outcomes with mixture therapy choices. Knowledge was offered on the 2023 San Antonio Breast Most cancers Symposium (SABCS), December 5-9, 2023.
The ELEVATE research is evaluating elacestrant together with inhibitors of the PI3K/AKT/mTOR pathway (everolimus and alpelisib) and cell-cycle pathway inhibitors (palbociclib, ribociclib, and abemaciclib). Outcomes reported at SABCS 2023 embody all mixture knowledge from Cohort 1 of the section 1b portion of the research, with the therapies exhibiting predictable security profiles that have been in line with prior research. Further cohorts are at the moment below analysis to evaluate pharmacokinetics (PK) and decide the advisable section 2 dose (RP2D) for every mixture. The total summary (1576517) will be seen here.
“It’s encouraging to see constructive preliminary security leads to varied mixture research of ORSERDU, together with promising preliminary efficacy knowledge in these trials,” stated Hope Rugo, MD, professor of medication, Division of Hematology and Oncology on the College of California San Francisco Helen Diller Household Complete Most cancers Heart. “We stay up for studying extra about ORSERDU’s function together settings and its potential throughout the spectrum of metastatic breast most cancers.”
The ELECTRA research is evaluating elacestrant together with abemaciclib. Section 1b of this research may even decide the advisable section 2 dose (RP2D) of this mixture in sufferers no matter metastases websites. Section 2 will consider the advantage of the mix in sufferers with ER+/HER2- superior or metastatic breast most cancers with mind metastases since each compounds have demonstrated the power to cross the blood-brain barrier. Outcomes reported at SABCS 2023 embody the three dose cohorts of the section 1b portion of the research, exhibiting a tolerable and manageable security profile with favorable preliminary efficacy in these sufferers, whatever the website of their metastases. The three cohorts have been accomplished with no sufferers experiencing dose limiting toxicities. No discontinuations have been noticed for any affected person past the remark interval as a result of toxicity. Most typical antagonistic occasions have been diarrhea, nausea, and neutropenia/neutrophil rely decreased. Solely neutropenia was related to grade 3 occasions with the mix; managed with normal dose discount for abemaciclib. The total summary (1576518) will be seen right here.
“Folks dwelling with ER+ metastatic breast most cancers are sometimes confronted with therapy resistance, inflicting a major want for progressive new choices,” stated Elcin Barker Ergun, CEO of the Menarini Group. “Whereas this knowledge is preliminary, we’re dedicated to advancing our complete analysis on ORSERDU together with different remedies, to probably assist improve affected person outcomes, with the objective of extending and bettering the lives of individuals with this illness.”
See here for particulars of the Menarini Group/Stemline Therapeutics’ full vary of displays at SABCS.
About The Elacestrant Scientific Improvement Program
Elacestrant can also be being investigated in a number of medical trials in metastatic breast most cancers illness, alone or together with different therapies. ELEVATE (NCT05563220) is a section 1b/2 medical trial that may consider the security and efficacy of elacestrant mixed with alpelisib, everolimus, palbociclib, abemaciclib, and ribociclib. ELECTRA (NCT05386108) is an open-label section 1b/2, multicenter research evaluating elacestrant together with abemaciclib in sufferers with ER+, HER2- breast most cancers. The section 2 portion evaluates this therapy routine in these sufferers with mind metastases. ELCIN (NCT05596409) is a section 2 trial evaluating the efficacy of elacestrant in sufferers with estrogen receptor constructive (ER+), human epidermal development issue receptor-2 adverse (HER2-) superior/metastatic breast most cancers who obtained one or two prior hormonal therapies and no prior cyclin-dependent kinase focusing on enzymes CDK4 and CDK6 inhibitor (CDK4/6i) within the metastatic setting. Elacestrant can also be being evaluated in early breast most cancers illness.
About ORSERDU (elacestrant)
U.S. Indication: ORSERDU (elacestrant), 345 mg tablets, is indicated for the therapy of postmenopausal girls or grownup males with estrogen receptor (ER)-positive, human epidermal development issue receptor 2 (HER2)-negative, ESR1-mutated superior or metastatic breast most cancers with illness development following not less than one line of endocrine remedy.
Full prescribing info for the U.S. will be discovered at www.orserdu.com.