EstroTep®

Radiopharmaceutical approved in France

Breast cancer, most common cancer among women

Breast Cancer

1 in 8 women will be diagnosed with breast cancer (1)

271270

estimated new cases in the US in 2019 (2)

42260

estimated breast cancer related deaths in 2019 (2)

90%

While 90% of people with breast cancer survive for 5 years after diagnosis, the survival rate widely depends on the stage of cancer at diagnosis (2)

70%

70% of breast cancer primary tumors are estrogen receptors-positive (3)

Sources :
(1) : breastcancer.org
(2) : cancer.net
(3) : cancernetwork.com

Metastatic breast cancer, affecting more than 160,000 (1) patients with unmet needs for treatment and diagnosis

Approximately 6 to 10 %

of new breast cancer cases are initially stage IV or metastatic in the US (3)

Approximately 20 to 30 %

 recurrence of all existing breast cancer patients (4)

< 30 %

5-year global survival rate for patients with metastatic breast cancer
despite availability of targeted therapies, inc. immuno-oncology therapies (2)

U.S. prevalence of metastatic breast cancer (2017-2025) (5)
Thousands of patients

US Prevalence of Metastatic Breast Cancer
Sources:
(1) : American Association for Cancer Research
(2) : Cancer.net
(3) : Metastatic Breast Cancer Network
(4) : Metastatic Breast Cancer Network
(5) : Mariotto2017, cancer.net

Metastatic breast cancer treatment is heavily dependant on patients’ estrogen receptors’ biomarker status

Breast Cancer Diagnosis
Source : NCCN guidelines

 

Pathologists regularly perform ER, PR and HER2 biomarker test on tissue samples collected on the initial workup, including bloodwork, medical imaging and biopsy.

Currently, biopsy is the only way to assess estrogen receptors status and it is not consistently used in metastatic breast cancer patients, particularly beyond diagnosis.

“…  I think there’s a lot of room for improvement in getting information about heterogeneity. Our tools for assessing heterogeneity today are relatively blunt– we don’t often do more than biopsy a single location. But heterogeneity is a real phenomenon and could impact treatment…”,

Medical Oncologist, Cancer Center

“…  Right now, we take one biopsy and assume the profile of the entire tumor is identical to the tumor at the biopsy location. That maybe true for some patients, but we know it’s not true for all. If we had better ways of assessing heterogeneity, we could design therapeutic strategies using this information and ideally improve patient outcomes…”,

Pathology Lab Director, University

“… A meaningful proportion (~50%) of ER+ and HER2 patients do not respond to CDK4/6+hormone therapy, which may be driven by estrogen receptors heterogeneity”,

Medical Oncologist, Cancer Center

Tumor heterogeneity has a critical role in the treatment decision for metastatic breast cancer patients

BREAKTHROUGH STUDY
View a recent breakthrough study supporting tumor heterogeneity importance
CLICK HERE

Most of phase III clinical trials for targeted therapies in mestastatic breast cancer depend on biomarkers characterization and tumor heterogeneity.

Worldwide metastatic breast cancer pipeline (2019*)

Metastatic Breast Cancer Pipeline
Source : LEK analysis of PharmaProjects

EstroTep, an innovative in-vivo biomarker for metastatic breast cancer

fes-picture-cropped
Fluoroestradiol

Usage: whole-body PET imaging to characterize estrogen receptor in metastatic breast cancer
Population: female and male with ER primary hormono-dependant metastatic breast cancer

EstroTep is approved in France, investigational use only in other countries.

Physicians express enthusiasm for EstroTep, which could have many benefits for helping clinicians better guide treatments:

  • Whole-body imaging of estrogen receptors status
  • Assessing tumor heterogeneity
  • Non-invasive compared to biopsy

 

“…  There are many situations where you are wondering if someone is truly estrogen receptors positive, and knowing this will change how you treat the patient. The major advantage here is in being able to definitively determine estrogen receptors status. Being non-invasive is important as well…”,
Medical Oncologist, Academic Medical Center

“Molecular Imaging provides an ideal platform for imaging biomarkers to guide targeted cancer therapy. Fluoroestradiol is perhaps the best example to date, where imaging can assess breast estrogen receptors expression over the full burden of metastatic breast cancer and guide optimal choices for endocrine therapy in a way not possible by biopsy alone.”,

Medical Oncologist, Academic Medical Center

“Molecular Imaging has the advantage either of being able to immediately appreciate the response to a treatment, either of being able to guide more effectively the treatment according to the results of a Positron Emission Tomography scan with a given marker.”,

Medical Oncologist, Academic Medical Center

For investigational use only – for more information, please contact medicalaffairs@zionexa.com

PRESS RELEASE
Zionexa announces FDA acceptance for review of New Drug Application for fluoroestradiol
VIEW PRESS RELEASE

Fluoroestradiol has demonstrated evidence for technical and clinical validity

Published results of recent breast cancer trials using fluoroestradiol

PublicationType of StudyNYear of CompletionKey Findings
Kurland, Clin Cancer Res 23:407, 2017Prospective single center992016Fluoroestradiol may help guide the timing of endocrine therapy and selection of targeted and/or cytotoxic chemotherapy
Chae, Lancet Oncology 20:546, 2019Prospective single center932019Fluoroestradiol results have high negative predictive value and positive predictive value for estrogen receptors status based on immunohistochemistry
Nienhuis, J Nucl Med 59:1212-1218, 2018Retrospective single center912018Fluoroestradiol uptake potentially identifies  biologically relevant estrogen receptors-positive metastatic breast cancer patient subgroups
Linden, J Clin Oncol 24:2793, 2006Prospective single center472006Fluoroestradiol can predict response to hormonal therapy
Peterson, J Nucl Med 49:367, 2008Prospective single center382008Fluoroestradiol uptake is correlated with immunohistochemistry of estrogen receptors expression
van Krutchen, J Nucl Med 53:182, 2012Prospective single center332012Fluoroestradiol could support therapy decisions by improving diagnostic understanding
van Krutchen, Eur J Nucl Med Mol Imaging 42:1674, 2015Prospective single center192015Fluoroestradiol may aid identification of patients that are unlikely to benefit from estradiol therapy

Ongoing breast cancer trials using fluoroestradiol

StudyType of StudyNAnticipated CompletionSignificant Endpoints
IMPACT
(NCT01957332)
Prospective multi center217Q4 2019
  • Clinical utility of fluoroestradiol
  • Correlation of fluoroestradiol to survival
  • Correlation of fluoroestradiol to fluorodeoxyglucose
  • Correlation of fluoroestradiol to immunohistochemistry
  • Cost-effectiveness of fluoroestradiol imaging
  • Quality of life
ECOG-ACRIN
(NCT02398773)
Prospective multi center99Q2 2022
  • Negative predictive value of fluoroestradiol
  • Therapy selection by fluoroestradiol
  • Predictive accuracy of fluoroestradiol for survival
  • Correlation of fluoroestradiol to immunohistochemistry
  • Heterogeneity of tumor fluoroestradiol uptake
TRANSCAN ET-FES
(EUDRACT 2013-000-287-29)
Randomized prospective multi center80Ongoing
  • Risk stratification by fluoroestradiol
  • Therapy selection by fluoroestradiol
  • Correlation of fluoroestradiol to fluorodeoxyglucose
FORESIGHT
(NCT03726931)
Prospective single center40Q4 2020
  • Percent of patients with a correctly changed treatment plan according to fluoroestradiol
  • Percent of cases where fluoroestradiol adds information over fluorodeoxyglucose
  • Correlation of fluoroestradiol to immunohistochemistry

Next generation in-vivo biomarkers

Find out more about what’s coming in in-vivo biomarkers for molecular imaging