EstroTep© (for France) – Cerianna™ (for US)
Radiopharmaceutical approved in France and in the US
Breast cancer, most common cancer among women
1 in 8 women will be diagnosed with breast cancer (1)
estimated new cases in the US in 2019 (2)
estimated breast cancer related deaths in 2019 (2)
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% 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
of new breast cancer cases are initially stage IV or metastatic in the US (3)
recurrence of all existing breast cancer patients (4)
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
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
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
heterogeneity in MBC?
a single lesion may have ER+ and ER- disease
estrogen receptor status can change over time,
especially following treatment
two lesions may have different estrogen
receptor status from one another
clinically relevant?
incomplete and imperfect information
typically from single-location biopsies
Tumor heterogeneity is likely a
contributing factor for
low response rates
BREAKTHROUGH STUDY
View a recent breakthrough study supporting tumor heterogeneity importance
CLICK HERE
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*)
Source : LEK analysis of PharmaProjects
EstroTep / Cerianna, innovative in-vivo biomarker for metastatic breast cancer
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
Cerianna is approved in the US
EstroTep is approved in France, investigational use only in other countries.
Physicians express enthusiasm for Cerianna / 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 USA and PETNET Solutions announce FDA approval of Cerianna™ (fluoroestradiol F18)
VIEW PRESS RELEASE
Zionexa USA and PETNET Solutions announce FDA approval of Cerianna™ (fluoroestradiol F18)
VIEW PRESS RELEASE
Fluoroestradiol has demonstrated evidence for technical and clinical validity
Published results of recent breast cancer trials using fluoroestradiol
| Publication | Type of Study | N | Year of Completion | Key Findings |
|---|---|---|---|---|
| Kurland, Clin Cancer Res 23:407, 2017 | Prospective single center | 99 | 2016 | Fluoroestradiol may help guide the timing of endocrine therapy and selection of targeted and/or cytotoxic chemotherapy |
| Chae, Lancet Oncology 20:546, 2019 | Prospective single center | 93 | 2019 | Fluoroestradiol results have high negative predictive value and positive predictive value for estrogen receptors status based on immunohistochemistry |
| Nienhuis, J Nucl Med 59:1212-1218, 2018 | Retrospective single center | 91 | 2018 | Fluoroestradiol uptake potentially identifies biologically relevant estrogen receptors-positive metastatic breast cancer patient subgroups |
| Linden, J Clin Oncol 24:2793, 2006 | Prospective single center | 47 | 2006 | Fluoroestradiol can predict response to hormonal therapy |
| Peterson, J Nucl Med 49:367, 2008 | Prospective single center | 38 | 2008 | Fluoroestradiol uptake is correlated with immunohistochemistry of estrogen receptors expression |
| van Krutchen, J Nucl Med 53:182, 2012 | Prospective single center | 33 | 2012 | Fluoroestradiol could support therapy decisions by improving diagnostic understanding |
| van Krutchen, Eur J Nucl Med Mol Imaging 42:1674, 2015 | Prospective single center | 19 | 2015 | Fluoroestradiol may aid identification of patients that are unlikely to benefit from estradiol therapy |
Ongoing breast cancer trials using fluoroestradiol
| Study | Type of Study | N | Anticipated Completion | Significant Endpoints |
|---|---|---|---|---|
| IMPACT (NCT01957332) | Prospective multi center | 217 | Q4 2019 |
|
| ECOG-ACRIN (NCT02398773) | Prospective multi center | 99 | Q2 2022 |
|
| TRANSCAN ET-FES (EUDRACT 2013-000-287-29) | Randomized prospective multi center | 80 | Ongoing |
|
| FORESIGHT (NCT03726931) | Prospective single center | 40 | Q4 2020 |
|
