Menarini Group Presents Updated Results from Pivotal Phase 3 EMERALD Trial at the 2022 San Antonio Breast Cancer Symposium (SABCS)
PR99053
Menarini Group Presents Updated Results from Pivotal Phase 3 EMERALD Trial at the 2022 San Antonio Breast Cancer Symposium (SABCS) that Demonstrate Elacestrant's PFS Increases with Duration of Prior CDK4/6i in ER+, HER2- in Metastatic Setting
FLORENCE, Italy, November, 30, 2022, /PRNewswire=KYODO JBN/--
• Elacestrant demonstrated longer progression-free survival (PFS) vs SOC
endocrine therapy with medians up to 8.6 months, positively associated with the
duration of prior treatment with CDK4/6 inhibitors
• Elacestrant side effects were manageable and consistent with previously
reported results
• Results demonstrate that elacestrant may have the potential to become a new
standard of care as a monotherapy endocrine sequencing option in ER+, HER2-
advanced or metastatic breast cancer after progression on CDK4/6i
The Menarini Group ("Menarini"), a privately held Italian pharmaceutical and
diagnostics company, and Stemline Therapeutics ("Stemline"), a wholly-owned
subsidiary of the Menarini Group, will present additional data from the Phase 3
EMERALD study (NCT03778931) of elacestrant, an investigational oral SERD,
during the upcoming San Antonio Breast Cancer Symposium (SABCS) being held from
December 6-10.
EMERALD is a Phase 3 registrational trial that demonstrated statistically
significant progression-free survival (PFS) with elacestrant vs SOC endocrine
monotherapy (fulvestrant, letrozole, anastrozole, exemestane), meeting both
primary endpoints in all patients and in those patients harbouring ESR1
mutations (ESR1-mut), following progression on prior CDK4/6 inhibitors
(CDK4/6i) in ER+, HER2- advanced or metastatic breast cancer.
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:
• In the all-patient population, a mPFS of 3.8 months on elacestrant vs 1.9
months on SOC, a 39% reduction in the risk of progression or death (HR=0.61 95%
CI: 0.45-0.83)
• In the ESR1-mut population, a mPFS of 8.6 months on elacestrant vs 1.9 months
on SOC, a 59% reduction in the risk of progression or death (HR=0.41 95% CI:
0.26-0.63)
For those who were exposed with CDK4/6i >/= 18 months prior to randomization
on EMERALD, elacestrant achieved:
• In the all-patient population, a mPFS of 5.5 months on elacestrant vs 3.3
months with SOC, a 30% reduction in the risk of progression or death (HR=0.70
95% CI: 0.48-1.02)
• In the ESR1-mut population, a mPFS of 8.6 months on elacestrant vs 2.1
months on SOC, a 53% reduction in the risk of progression or death (HR=0.47 CI:
0.20-0.79).
Updated safety data were consistent with previously reported results. Most of
the adverse events (AEs), including nausea, were grade 1 and 2, and only 3.4%
and 0.9% of the patients discontinued trial therapy because of an AE on
elacestrant and SOC, respectively. A low percentage of patients received an
antiemetic; 8.0% on elacestrant, 3.7% on fulvestrant, and 10.3% on AI,
respectively. No hematological safety signal was observed and none of the
patients in either of the two treatment arms had sinus bradycardia.
Virginia Kaklamani, MD, DSc, breast medical oncologist and professor of
medicine, UT Health San Antonio, MD Anderson Cancer Center, commented, "These
results show that when used as a single agent, elacestrant provided mPFS up to
8.6 months, based on the duration of previous CDK4/6 inhibitor therapy, with a
manageable safety profile and the convenience of an oral tablet. This suggests
elacestrant may have the potential to become a new standard of care as a
monotherapy endocrine sequencing option in ER+, HER2- advanced breast cancer
after progression on CDK4/6i, before moving to combination therapies."
"These results further highlight elacestrant's potential to change the
treatment paradigm of ER+, HER2- advanced or metastatic breast cancer.
Elacestrant is under Priority Review with the U.S. Food and Drug Administration
(FDA) with a target PDUFA date of February 17, 2023," commented Elcin Barker
Ergun, Chief Executive Officer of the Menarini Group.
A complete list of key Menarini Group presentations at SABCS is below.
Lead Author Name |
Abstract Number and Title |
Presentation Details |
V. Kaklamani |
GS3-01. EMERALD Phase 3 trial of elacestrant versus standard of care endocrine therapy in patients with ER+, HER2- metastatic breast cancer: Updated results by duration of prior CDK4/6i in metastatic setting |
December 8, 2022 8:30-8:45 AM CT Oral Presentation General Session 3 Hall 3 |
H. Rugo |
OT2-01-03. ELEVATE: A Phase 1b/2, open-label, umbrella study evaluating elacestrant in various combinations in women and men with metastatic breast cancer (mBC) |
December 7, 2022 5:00-6:30 PM CT Ongoing Trials Poster Session 2 Hall 1 |
M. Piccart |
PD18-05. MEN1611, a PI3K Inhibitor, combined with trastuzumab (T) +/- fulvestrant (F) for HER2+/PIK3CA mutant (mut) advanced or metastatic (a/m) breast cancer (BC): updated safety and efficacy results from the ongoing Phase 1b study (B-PRECISE-01) |
December 9, 2022 7:00-8:15 AM CT Spotlight Poster Discussion 18 Stars at Night Ballroom - Hall 3&4 |
The Menarini Group obtained global licensing rights for elacestrant in July
2020 from Radius Health, Inc., who conducted and successfully completed the
EMERALD study. The Menarini Group is now fully responsible for global
registration, commercialization, and further development activities for
elacestrant.
About Elacestrant (RAD1901) and the EMERALD Phase 3 Study
Elacestrant is an investigational selective estrogen receptor degrader (SERD).
In 2018, elacestrant received Fast Track designation from the FDA. Preclinical
studies completed prior to EMERALD 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. The EMERALD Phase 3 trial is a randomized, open
label, active-controlled study evaluating elacestrant as second- or third-line
monotherapy in ER+, HER2- advanced/metastatic breast cancer patients. The study
enrolled 478 patients who had received prior treatment with one or two lines of
endocrine therapy, including a CDK 4/6 inhibitor. Patients in the study were
randomized to receive either elacestrant or the investigator's choice of an
approved hormonal agent. The primary endpoints of the study were
progression-free survival (PFS) in the overall patient population and in
patients with estrogen receptor 1 gene (ESR1) mutations. Secondary endpoints
included evaluation of overall survival (OS), objective response rate (ORR),
and duration of response (DOR) and safety.
About The Menarini Group
The Menarini Group is a leading international pharmaceutical and diagnostics
company, with a turnover of over $4 billion and over 17,000 employees. Menarini
is focused on therapeutic areas with high unmet needs with products for
cardiology, oncology, pneumology, gastroenterology, infectious diseases,
diabetology, inflammation, and analgesia. With 18 production sites and 9
Research and Development centers, Menarini's products are available in 140
countries worldwide. For further information, please visit www.menarini.com.
About Stemline
Stemline Therapeutics, a wholly owned subsidiary of The Menarini Group, is a
commercial-stage biopharmaceutical company focused on the development and
commercialization of novel oncology therapeutics. Stemline commercializes a
novel targeted treatment directed to CD123 for patients with blastic
plasmacytoid dendritic cell neoplasm (BPDCN) in the United States and Europe
which is also being evaluated as monotherapy and in combination with other
agents, in additional clinical trials for a variety of other indications.
Stemline has an extensive clinical pipeline of small molecules and biologics in
various stages of development for a host of solid and hematologic cancers.
About Radius
Radius is a global biopharmaceutical company focused on addressing unmet
medical needs in the areas of bone health and oncology. Radius' lead product,
TYMLOS (R) (abaloparatide) injection, was approved by the U.S. Food and Drug
Administration for the treatment of postmenopausal women with osteoporosis at
high risk for fracture. The Radius clinical pipeline includes investigational
abaloparatide injection for potential use in the treatment of men with
osteoporosis and the investigational drug, elacestrant (RAD1901), for potential
use in the treatment of hormone-receptor positive breast cancer out-licensed to
Menarini Group.
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SOURCE: Menarini Industrie Farmaceutiche Riunite
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