On May 25, 2026 The Menarini Group ("Menarini"), a leading international pharmaceutical and diagnostics company, and Stemline Therapeutics, Inc. ("Stemline"), a wholly-owned subsidiary of the Menarini Group, focused on bringing transformational oncology treatments to cancer patients, reported that new data related to elacestrant and tagraxofusp will be presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.
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New data exploring the safety and preliminary efficacy of elacestrant in combination with capivasertib in patients with ER+/HER2- PI3K/AKT/PTEN- pathway altered metastatic breast cancer (mBC) from the phase 1/2 ELEVATE study will be presented. Additional details on ongoing studies of elacestrant in combination, in the advanced setting, will be shared: ADELA (pivotal phase 3 combination with everolimus); ELECTRA (phase 1b/2 combination with abemaciclib in patients with brain metastases); and CAPELA (phase 2 combination with capecitabine). Lastly, an update from the ELEGANT study, exploring elacestrant as adjuvant treatment in node-positive early breast cancer with high risk of recurrence, will be presented at the congress.
Also accepted for presentation is new phase 2 tagraxofusp combination data in patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN), which will be presented by Naveen Pemmaraju, MD, Professor, Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center. Additionally, Stemline’s partner, Karyopharm Therapeutics, will present a late-breaking oral presentation from the phase 3 SENTRY trial of selinexor in JAKi naïve patients with myelofibrosis (MF). Selinexor is marketed in the U.S. by Karyopharm Therapeutics, and in the EU by Stemline.
"The extensive oncology data that will be presented, encompassing both solid tumors and hematologic malignancies, highlights our dedication to tackling the most difficult-to-treat cancers with high unmet needs," said Elcin Barker Ergun, CEO of the Menarini Group. "Our focus remains on accelerating innovation to provide transformational, targeted therapies that offer meaningful advances to patients and the healthcare communities dedicated to their care."
See below for full details of upcoming presentations:
2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting
Lead Author
Abstract Title and ID
Presentation
Details
Elacestrant
Wassim McHayleh
Elacestrant in combination with capivasertib in patients with
ER+/HER2- advanced breast cancer: Update from ELEVATE, a
phase 1b/2 open-label, umbrella study
Abstract: 1098
June 1, 2026; 1:30 – 4:30 PM CT
Poster Board 212
Aditya Bardia
ELEGANT: Elacestrant versus standard endocrine therapy in
women and men with node-positive, estrogen receptor-positive
(ER+), HER2-negative (HER2-), early breast cancer with high risk of
recurrence in a global, multicenter, randomized, open-label phase 3 study
Abstract: TPS1153
June 1, 2026; 1:30 – 4:30 PM CT
Poster Board 262a
Antonio Llombart-
Cussac
ADELA: A double-blind, placebo-controlled, randomized phase 3
trial of elacestrant + everolimus versus elacestrant + placebo in
ER+/HER2- advanced breast cancer patients with ESR1-mutated
tumors progressing on endocrine therapy + CDK4/6i*#
Abstract: TPS1154
June 1, 2026; 1:30 – 4:30 PM CT
Poster Board 262b
Nuhad Ibrahim
ELECTRA: An open-label multicenter, phase 1b/2 study of
elacestrant in combination with abemaciclib in patients with brain
metastasis from ER+/HER2- breast cancer
Abstract: TPS1155
June 1, 2026; 1:30 – 4:30 PM CT
Poster Board 263a
Kristina Fanucci
CAPELA: A phase II multicenter open-label randomized study of
capecitabine in combination with elacestrant versus capecitabine
alone in advanced estrogen receptor (ER)–positive breast cancer
(TBCRC 070)*
Abstract: TPS1156
June 1, 2026; 1:30 – 4:30 PM CT
Poster Board 263b
Tagraxofusp
Naveen Pemmaraju
A Phase II Trial of Tagraxofusp, Hyper-CVAD, and Venetoclax for
Patients with Newly Diagnosed or Relapsed/Refractory BPDCN*
Abstract: 6502
Oral Presentation
June 2, 2026; 10:09 – 10:21 am CT
Selinexor
John Mascarenhas
Selinexor plus ruxolitinib in JAK inhibitor–naïve myelofibrosis:
Phase 3 SENTRY trial*
Abstract: LBA6500
Oral Presentation
June 2, 2026; 9:45 am – 12:45 pm CT
*Denotes investigator sponsored research or collaborative research
#The ADELA study is a pivotal study co-sponsored with MEDSIR
About The Elacestrant Clinical Development Program
Elacestrant is also being investigated in several company-sponsored clinical trials in breast cancer disease, alone or in combination with other therapies. ELEGANT (NCT06492616) is a phase 3 trial evaluating the effectiveness of elacestrant versus standard endocrine therapy in women and men with node-positive, ER+, HER2- early breast cancer with high risk of recurrence. ADELA (NCT06382948) is a phase 3 randomized, double-blinded trial evaluating elacestrant in combination with everolimus in patients with ER+, HER2- mBC with ESR1-mut tumors. ELEVATE (NCT05563220) is a phase 1b/2 clinical trial evaluating the safety and efficacy of elacestrant combined with alpelisib, everolimus, capivasertib, palbociclib, ribociclib or abemaciclib. ELECTRA (NCT05386108) is an open-label phase 1b/2, multicenter study evaluating elacestrant in combination with abemaciclib in patients with ER+, HER2- breast cancer. The phase 2 portion evaluates this treatment regimen in patients with brain metastases. ELCIN (NCT05596409) is a phase 2 trial evaluating the efficacy of elacestrant in patients with ER+, HER2- advanced/metastatic breast cancer who received one or two prior hormonal therapies and no prior CDK4/6 inhibitors in the metastatic setting. Elacestrant is also being evaluated in additional investigator-led trials, in trials conducted in collaboration with other companies, in metastatic breast cancer as well as in early disease.
To report SUSPECTED ADVERSE REACTIONS, contact Stemline Therapeutics, Inc.
at [email protected]. All of the relevant information can be found at View Source
Full prescribing information for elacestrant can be found at View Source
Full prescribing information for selinexor can be found at View Source
Full prescribing information for tagraxofusp can be found at View Source
(Press release, Menarini, MAY 25, 2026, View Source [SID1234666036])