Early amcenestrant data featured at ASCO support its potential to become a new endocrine backbone therapy for ER+/HER2- breas...
19 Mai 2021 - 11:00PM
Early amcenestrant data featured at ASCO support its potential to
become a new endocrine backbone therapy for ER+/HER2- breast cancer
Early amcenestrant data
featured at ASCO support its potential to become a new endocrine
backbone therapy for ER+/HER2-
breast cancer
- Amcenestrant, an investigational oral selective estrogen
receptor degrader (SERD), achieved an objective response rate of
34% and a clinical benefit rate of 74% in Phase 1 study (AMEERA-1)
in combination with palbociclib
- Overall safety profile of amcenestrant with palbociclib is
consistent with what was observed in monotherapy, without signs of
significant cardiac or ocular side effects
- The Phase 3 combination study (AMEERA-5) of amcenestrant with
palbociclib in the first-line setting was initiated in October 2020
and is successfully recruiting patients
- The pivotal study (AMEERA-3) of amcenestrant versus physician’s
choice in locally advanced or metastatic estrogen receptor-positive
(ER+) breast cancer is fully recruited; readout expected in H2
2021
PARIS –
May 19, 2021
– Phase 1 data from the AMEERA-1 study evaluating
amcenestrant, an investigational oral selective estrogen receptor
degrader (SERD), will be presented at the 2021 American Society of
Clinical Oncology (ASCO) Annual Meeting. In a pooled analysis,
amcenestrant in combination with palbociclib showed encouraging
antitumor activity in postmenopausal women with estrogen
receptor-positive (ER+)/human epidermal growth factor receptor
2-negative (HER2-) metastatic breast cancer (MBC).
“These early clinical data show that the
combination of amcenestrant with palbociclib achieved encouraging
antitumor activity,” said Sarat Chandarlapaty, M.D., Ph.D., Medical
Oncologist, Memorial Sloan Kettering Cancer Center. “The analysis
also demonstrated no clinically significant cardiac or ocular
findings and an overall safety profile in line with what we saw in
the monotherapy setting. It’s notable to see this kind of activity
in patients with ER+ metastatic breast cancer, where there is a
clear need for new therapeutic options.”
In this preliminary analysis from the open-label AMEERA-1 study,
amcenestrant was evaluated in dose escalation cohorts (Part C) at
200mg (n=9) and 400mg (n=6) daily and in a dose expansion cohort
(Part D; n=30) at 200mg daily, all in combination with a standard
dose of palbociclib. Eligible patients included post-menopausal
women with ER+/HER2- MBC who were pre-treated with endocrine
therapy in the advanced setting for at least six months or had
resistance to adjuvant endocrine therapy.
In the pooled population exposed with amcenestrant at 200mg
daily evaluable for response (n=35), the objective response rate
(ORR) was 34% (90% CI: 21.1-49.6), with confirmed partial responses
(PR) in 12/35 patients, and the clinical benefit rate (CBR) was 74%
(90% CI: 59.4-85.9), with clinical benefit in 26/35 patients at 24
weeks. Amcenestrant 200mg daily in combination with palbociclib
demonstrated a favorable overall safety profile (n=39), with
treatment related adverse events (TRAEs) attributable to
amcenestrant similar to those observed with monotherapy. For all
grade events, amcenestrant TRAEs occurred in 72% and to palbociclib
in 90% of patients, and for grade ≥3 in 15% and 46% of patients,
respectively. The most frequent non-hematological amcenestrant
TRAEs included fatigue (18%) and nausea (18%), all grade ≤2. No
clinically significant cardiac or ocular safety findings
occurred.
“The Phase 3 AMEERA-5 study was built upon
promising preclinical and clinical data, including the data
presented here at ASCO, and expands our knowledge of amcenestrant
as a potential best-in-class oral endocrine backbone therapy for
ER+/HER2- breast cancer,” said John Reed, M.D., Ph.D., Global Head
of Research and Development at Sanofi. “A significant need exists
for more treatment options for ER+ breast cancer, the most common
type of breast cancer, accounting for approximately 75% of all
breast cancers diagnosed today.”
Amcenestrant is an oral SERD that antagonizes
and degrades the estrogen receptor (ER) resulting in inhibition of
the ER signaling pathway. Amcenestrant is currently under clinical
investigation and its safety and efficacy have not been evaluated
by any regulatory authority.
Amcenestrant
clinical
development
program
The comprehensive development program for
amcenestrant has been designed to evaluate its role: (1) as a
single agent in second-line or later lines of treatment of
ER+/HER2- MBC, (2) in combination with palbociclib in the
first-line treatment of ER+/HER2- MBC, and (3) to explore its
potential in early-stage breast cancer patients in the adjuvant
setting. Late last year, the Phase 3 AMEERA-5 clinical trial
investigating amcenestrant in combination with palbociclib, a
cyclin-dependent kinase (CDK) 4/6 inhibitor, as a first-line
therapy for patients with ER+ MBC, was initiated.
A pivotal study (AMEERA-3) of amcenestrant versus physician’s
choice in locally advanced or metastatic ER+ breast cancer is fully
recruited. The pivotal readout is now expected in H2 2021. Of note,
the trial recently passed a Data Safety Monitoring Committee (DSMC)
futility analysis.
About ER+ metastatic breast
cancer
MBC is breast cancer that has spread outside the
mammary gland to another part of the body, such as the liver,
brain, bones or lungs. It is also known as Stage IV and is the most
advanced stage of breast cancer.1 About two of every three cases of
breast cancer are HR+, meaning the cancer is fueled by the hormones
estrogen or progesterone.2 HR+ breast cancers can be classified as
ER+ and/or progesterone receptor-positive (PR+).2 ER+ breast cancer
accounts for approximately 75% of all breast cancers3 and is the
most common type of breast cancer diagnosed today.4 The five-year
relative survival for distant (cancer that has metastasized) female
breast cancer is 28.1%.5 Endocrine therapies were among the first
treatments to be administered for HR+ MBC and are considered
standard of care in the first-line setting. However, new options
are needed as resistance often emerges, limiting the effectiveness
of these treatments for patients with metastatic disease over
time.6
About the AMEERA-1 clinical
trial
AMEERA-1 is an open-label, Phase 1/2,
first-in-human study designed to evaluate amcenestrant as a
monotherapy and in combination with targeted therapies in
postmenopausal women with ER+/HER2- MBC. Parts A (dose escalation)
and B (dose expansion) were designed to determine the maximum
tolerated dose of amcenestrant administered as monotherapy, while
Parts C and D are evaluating dose escalation and expansion for
amcenestrant in combination with palbociclib to determine the
recommended Phase 2 dose for the combination and to characterize
its safety profile. Primary efficacy objectives include antitumor
activity by ORR and CBR per RECIST v1.1 criteria, as well as
characterizing the overall safety profile of amcenestrant as a
monotherapy and in combination with palbociclib. Eligible patients
included women with histological diagnosis of breast adenocarcinoma
with locally advanced or metastatic ER+/HER2- disease and at least
six months of prior exposure to endocrine therapy, including
patients with early relapse while on adjuvant endocrine therapy
that was initiated more than 24 months ago, or who relapsed less
than 12 months after completion of adjuvant endocrine therapy.7
For more information on amcenestrant clinical
trials, please visit www.clinicaltrials.gov.
Dr. Chandarlapaty has provided consulting services to
Sanofi.
|
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1 Breastcancer.org. Metastatic Breast Cancer.
https://www.breastcancer.org/symptoms/types/recur_metast. Accessed
March 2021.2 American Cancer Society. Hormone Therapy for Breast
Cancer.
https://www.cancer.org/cancer/breast-cancer/treatment/hormone-therapy-for-breast-cancer.html.
Accessed February 2021.3 Sanofi Science and Innovation. Unlock a
Promising Therapeutic Approach for Breast Cancer
https://www.sanofi.com/en/science-and-innovation/unlock-the-potential-of-a-promising-therapeutic-approach-for-breast-cancer.
Accessed August 2020.4 Silverman, A. ER-Positive Breast Cancer:
Prognosis, Life Expectancy, and More.
Heathline.https://www.healthline.com/health/breast-cancer/er-positive-prognosis-life-expectancy#:~:text=Estrogen%20receptor%2Dpositive%20(ER%2D,cancer%20are%20hormone%20receptor%2Dpositive.
Accessed February 2021.5 National Cancer Institute. Cancer Stat
Facts: Female Breast Cancer.
https://seer.cancer.gov/statfacts/html/breast.html. Accessed
February 2021.6 Kaklamani, V. G., & Gradishar, W. J. (2017).
Endocrine Therapy in the Current Management of Postmenopausal
Estrogen Receptor-Positive Metastatic Breast Cancer. The
oncologist, 22(5), 507–517.
https://doi.org/10.1634/theoncologist.2015-0464. Accessed October
2020.7 ClinicalTrials.gov. Phase 1 / 2 Study of SAR439859 Single
Agent and in Combination With Other Anti-cancer Therapies in
Postmenopausal Women With Estrogen Receptor Positive Advanced
Breast Cancer (AMEERA-1).
https://www.clinicaltrials.gov/ct2/show/NCT03284957. Accessed April
2021.
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