HR Positive/ Her2 Negative Breast Cancer - Pipeline Insight, 2023 - ResearchAndMarkets.com
2023-03-22
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This "HR Positive/ HER2 Negative Breast Cancer - Pipeline Insight, 2023" report provides comprehensive insights about 50+ companies and 53+ pipeline drugs in HR Positive/ HER2 Negative Breast Cancer pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.
Geography Covered
Global coverage
Three common tests employed to test for HER2 levels are chromogenic in situ hybridization (CISH), immunohistochemistry (IHC) and fluorescent in situ hybridization (FISH). Depending on the levels of HER2 or ERBB2 in the laboratory test breast cancer is classified as HER2 or ERBB2 positive or HER2 negative breast cancer. In HER2 or ERBB2 receptors in a normal breast maintains growth, division and repairing while in HER2 or ERBB2 positive breast cancer over-expression of HER2 or ERBB2 is seen. In case of HER2 negative breast cancer the levels of HER2 protein is in normal.
The present goal of therapy for early HR+/HER2- breast cancer (BC)HR+/HER2- breast cancer (BC) is to optimize disease-free survival (DFS) and overall survival (OS) rates with the currently available therapies while avoiding any relevant long-term sequalae. Local therapies have evolved toward less aggressive techniques (i.e. breast-preserving surgery, sentinel lymph node biopsy and intraoperative radiotherapy), which significantly reduce the long-term sequalae observed with more radical treatments.
Endocrine therapy (ET) is still the cornerstone of adjuvant treatment because it significantly reduces BC relapse and mortality. Adjuvant chemotherapy is today recommended only for a particular subset of patients with a high risk of recurrence with ET alone, identified through genomic assays, age and/or disease stage. Bisphosphonates reduce the risk of bone metastasis and produce a slight although statistically significant improvement in survival in postmenopausal women. The CDK 4/6 inhibitor abemaciclib has been recently approved by the US FDA for patients at high risk of relapse.
The report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the HR Positive/ HER2 Negative Breast Cancer pipeline landscape is provided which includes the disease overview and HR Positive/ HER2 Negative Breast Cancer treatment guidelines. The assessment part of the report embraces, in depth HR Positive/ HER2 Negative Breast Cancer commercial assessment and clinical assessment of the pipeline products under development.
Report Highlights
This segment of the HR Positive/ HER2 Negative Breast Cancer report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.
Camizestrant is a potent, next-generation oral SERD and pure ER? antagonist, that has demonstrated anti-cancer activity across a range of preclinical models, including those with ER-activating mutations.
The asset has been shown to promising anti-tumour profile when administered alone or in combination with palbociclib and thus, the company is running a Phase III trial for the same.
Dato-DXd: Daiichi Sankyo, Inc.
Datopotamab deruxtecan (Dato-DXd) is an investigational currently in Phase III for HR-positive, HER2- negative breast cancerHER2- negative breast cancer. It is a TROP2 directed antibody drug conjugate (ADC) designed using Daiichi Sankyo's proprietary DXd ADC technology, datopotamab deruxtecan is one of the three lead ADCs in the oncology pipeline of Daiichi Sankyo, and one of the most advanced programs in AstraZeneca's ADC scientific platform.
Datopotamab deruxtecan is comprised of a humanized anti-TROP2 IgG1 monoclonal antibody, developed in collaboration with Sapporo Medical University, attached to a number of topoisomerase I inhibitor payloads, an exatecan derivative, via tetrapeptide-based cleavable linkers.
CX-2009: CytomX Therapeutics
CX-2009 is a Probody drug conjugate that consists of a humanized anti-CD166 monoclonal antibody conjugated to DM4, a potent microtubule inhibitor known to be active against multiple cancer types.
It is currently being tested in Phase II trial in Advanced HR-Positive/HER2-Negative Breast CancerHER2-Negative Breast Cancer and of Praluzatamab Ravtansine as Monotherapy and in Combination with Pacmilimab (CX-072) in Advanced Triple-Negative Breast Cancer.
RGT-419B: Regor Therapeutics
RGT-419B is a new generation of CDK inhibitor with an optimized kinase activity spectrum. The clinical development program of RGT-419B is designed to address the unmet medical needs of patients who are refractory or have relapsed after previous treatment, providing new opportunities to improve survival and quality of life for patients with advanced/metastatic breast cancer.
It is currently being tested in Phase I trial in in subjects with Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative Advanced/Metastatic Breast Cancer.
There are approx. 50+ key companies which are developing the therapies for HR Positive/ HER2 Negative Breast Cancer. The companies which have their HR Positive/ HER2 Negative Breast Cancer drug candidates in the most advanced stage, i.e. phase III include, AstraZeneca.
Phases
The report covers around 53+ products under different phases of clinical development like
Late stage products (Phase III)
Mid-stage products (Phase II)
Early-stage product (Phase I)
Pre-clinical and Discovery stage candidates
Discontinued & Inactive candidates
Route of Administration
Intra-articular
Intraocular
Intrathecal
Intravenous
Ophthalmic
Oral
Parenteral
Subcutaneous
Topical
Transdermal
Molecule Type
Products have been categorized under various Molecule types such as
Oligonucleotide
Peptide
Small molecule
Product Type
Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.
Pipeline Development Activities
Therapeutic Assessment
Unmet Needs
Impact of Drugs
Pipeline Product Profiles
Therapeutic Assessment
Pipeline Assessment
Inactive drugs assessment
Unmet Needs
Key Questions Answered
Current Treatment Scenario and Emerging Therapies:
How many companies are developing HR Positive/ HER2 Negative Breast Cancer drugs?
What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
What are the key designations that have been granted to the emerging drugs?
Key Players
Regor Therapeuics
Merus N.V.
Key Products
CX-2009
EOC202
EP0062
HRS8807
AND019
For more information about this clinical trials report visit https://www.researchandmarkets.com/r/g7co1l
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