HR Positive/ HER2 Negative Breast Cancer Pipeline Analysis 2024: FDA Approvals and Emerging Therapies by DelveInsight | Eli Lilly, Laekna, Sermonix Pharma, BeiGene, Olema Pharma, AstraZeneca

(Las Vegas, Nevada, United States) As per DelveInsight’s assessment, globally, HR Positive/ HER2 Negative Breast Cancer pipeline constitutes 50+ key companies continuously working towards developing 53+ HR Positive/ HER2 Negative Breast Cancer treatment therapies, analysis of Clinical Trials, Therapies, Mechanism of Action, Route of Administration, and Developments analyzes DelveInsight.

“HR Positive/ HER2 Negative Breast Cancer Pipeline Insight, 2024“ report by DelveInsight outlines comprehensive insights into the present clinical development scenario and growth prospects across the HR Positive/ HER2 Negative Breast Cancer Market.

 

The HR Positive/ HER2 Negative Breast Cancer Pipeline report embraces in-depth commercial and clinical assessment of the pipeline products from the pre-clinical developmental phase to the marketed phase. The report also covers a detailed description of the drug, including the mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, collaborations, mergers acquisition, funding, designations, and other product-related details.

 

Some of the key takeaways from the HR Positive/ HER2 Negative Breast Cancer Pipeline Report:

  • Companies across the globe are diligently working toward developing novel HR Positive/ HER2 Negative Breast Cancer treatment therapies with a considerable amount of success over the years. 

  • HR Positive/ HER2 Negative Breast Cancer companies working in the treatment market are Seagen Inc., Regor Pharmaceuticals, Verastem Oncology, Olema Pharmaceuticals, Inc, Tyme, Inc., EOC Pharma, CytomX Therapeutics, Daiichi Sankyo, Inc., AstraZeneca, Chia Tai Tianqing Pharmaceutical Group, and others, are developing therapies for the HR Positive/ HER2 Negative Breast Cancer treatment 

  • Emerging HR Positive/ HER2 Negative Breast Cancer therapies in the different phases of clinical trials are- SGN-B7H4V, RGT-419B, Abemaciclib + VS-6766 + Fulvestrant, OP-1250, SM-88, EOC202, CX-2009, Dato-DXd, Camizestrant + Palbociclib, TQB3616, and others are expected to have a significant impact on the HR Positive/ HER2 Negative Breast Cancer market in the coming years.   

  • In October 2023, Daiichi Sankyo and AstraZeneca have announced positive interim results for datopotamab deruxtecan (Dato-DXd) in treating inoperable or metastatic hormone receptor (HR) positive, HER2 negative breast cancer in patients who have previously received endocrine-based and systemic therapies.

  • In September 2023, The initial positive outcomes from the TROPION-Breast01 Phase III trial indicated that datopotamab deruxtecan (Dato-DXd) showed a statistically notable and clinically meaningful improvement in the primary metric of progression-free survival (PFS) compared to the investigator-selected chemotherapy. These results were evident among patients managing inoperable or metastatic hormone receptor (HR)-positive, HER2-low, or negative (IHC 0, IHC 1+, or IHC 2+/ISH-) breast cancer, previously treated with endocrine-based therapy and at least one systemic therapy.

  • In January 2023, Context Therapeutics Inc., a company dedicated to pioneering innovative therapies for solid tumors, particularly focusing on female-related cancers, announced that its clinical trial partner, Stemline Therapeutics, Inc., a wholly owned subsidiary of The Menarini Group (“Menarini”), obtained FDA approval for ORSERDU (elacestrant). This approval targets the treatment of postmenopausal women or adult men dealing with estrogen receptor–positive (ER+), HER2-negative (HER2-), and Estrogen Receptor 1 gene (ESR1)-mutated advanced or metastatic breast cancer. ORSERDU is intended for individuals experiencing disease progression following at least one line of endocrine therapy.

  • On January 27, 2023, The FDA has granted approval for elacestrant (Orserdu) to treat individuals with advanced or metastatic breast cancer who are postmenopausal women or adult men with ER-positive, HER2-negative, ESR1-mutated conditions. This approval is specifically for those patients who have experienced disease progression after undergoing at least one round of endocrine therapy.

  • In January 2023, ENHERTU® (trastuzumab deruxtecan) by Daiichi Sankyo and AstraZeneca has received approval in the European Union (EU) as a standalone therapy. It is intended for adult patients dealing with unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-) breast cancer. These patients should have undergone previous chemotherapy in the metastatic setting or experienced disease recurrence either during or within six months after completing adjuvant chemotherapy.

  • In February 2023, Gilead Sciences’ Trodelvy, newly approved by the FDA, has made a significant entry into the breast cancer arena, which is pivotal for the drug’s commercial success and the broader oncology aspirations of the company. Gilead announced the FDA approval of Trodelvy for previously treated HR-positive, HER2-negative breast cancer. Patients eligible for this therapy must have undergone endocrine therapy and received at least two additional therapies in the metastatic setting. Trodelvy had previously obtained approval for treating triple-negative breast cancer. However, the HR-positive, HER2-negative disease encompasses a considerably larger patient group, constituting approximately two-thirds of all breast cancer cases.

 

HR Positive/ HER2 Negative Breast Cancer Overview

HR Positive/HER2 Negative breast cancer is a subtype of breast cancer defined by the presence of certain receptors and the absence of others on the surface of cancer cells.

 

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Emerging HR Positive/ HER2 Negative Breast Cancer Drugs Under Different Phases of Clinical Development Include:

  • SGN-B7H4V: Seagen Inc.

  • RGT-419B: Regor Pharmaceuticals

  • Abemaciclib + VS-6766 + Fulvestrant: Verastem Oncology

  • OP-1250: Olema Pharmaceuticals, Inc

  • SM-88: Tyme, Inc.

  • EOC202: EOC Pharma

  • CX-2009: CytomX Therapeutics

  • Dato-DXd: Daiichi Sankyo, Inc.

  • Camizestrant + Palbociclib: AstraZeneca

  • TQB3616: Chia Tai Tianqing Pharmaceutical Group

 

HR Positive/ HER2 Negative Breast Cancer Route of Administration

HR Positive/ HER2 Negative Breast Cancer pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs, such as 

  • Intra-articular

  • Intraocular

  • Intrathecal

  • Intravenous

  • Ophthalmic

  • Oral

  • Parenteral

  • Subcutaneous

  • Topical

  • Transdermal

 

HR Positive/ HER2 Negative Breast Cancer Molecule Type

HR Positive/ HER2 Negative Breast Cancer Products have been categorized under various Molecule types, such as

  • Oligonucleotide

  • Peptide

  • Small molecule

 

HR Positive/ HER2 Negative Breast Cancer Pipeline Therapeutics Assessment

  • HR Positive/ HER2 Negative Breast Cancer Assessment by Product Type

  • HR Positive/ HER2 Negative Breast Cancer By Stage and Product Type

  • HR Positive/ HER2 Negative Breast Cancer Assessment by Route of Administration

  • HR Positive/ HER2 Negative Breast Cancer By Stage and Route of Administration

  • HR Positive/ HER2 Negative Breast Cancer Assessment by Molecule Type

  • HR Positive/ HER2 Negative Breast Cancer by Stage and Molecule Type

 

DelveInsight’s HR Positive/ HER2 Negative Breast Cancer 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

 

Further HR Positive/ HER2 Negative Breast Cancer product details are provided in the report. Download the HR Positive/ HER2 Negative Breast Cancer pipeline report to learn more about the emerging HR Positive/ HER2 Negative Breast Cancer therapies

 

Some of the key companies in the HR Positive/ HER2 Negative Breast Cancer Therapeutics Market include:

Key companies developing therapies for HR Positive/ HER2 Negative Breast Cancer are – Eli Lilly and Company, Laekna Limited, Sermonix Pharmaceuticals Inc., BeiGene, Olema Pharmaceuticals, AstraZeneca, Radius Health, Adagene Inc, H3 Biomedicine Inc., Daiichi Sankyo, Inc., Shanghai Hengrui Pharmaceutical Co., Ltd., Tyme, Inc., PIQUR Therapeutics, Pfizer, Merus N.V., Seagen, Relay Therapeutics, Inc., OncoSec Medical Incorporated, CSPC ZhongQi Pharmaceutical Technology Co., Ltd., Pfizer, InventisBio Co., Ltd, Hoffmann-La Roche, Angiochem, Bristol-Myers Squibb, Eisai Co., Ltd., Context Therapeutics, Boehringer Ingelheim, CytomX Therapeutics, Beta Pharma (Suzhou) Co., Ltd., Modra Pharmaceuticals, MedImmune LLC, QED Therapeutics, Inc., Blueprint Medicines Corporation, TransThera Sciences (Nanjing), Inc., HUTCHMED, VelosBio Inc., Dantari, Inc., GlaxoSmithKline, G1 Therapeutics, Inc., and others.

 

HR Positive/ HER2 Negative Breast Cancer Pipeline Analysis:

The HR Positive/ HER2 Negative Breast Cancer pipeline report provides insights into 

  • The report provides detailed insights about companies that are developing therapies for the treatment of HR Positive/ HER2 Negative Breast Cancer with aggregate therapies developed by each company for the same.

  • It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for HR Positive/ HER2 Negative Breast Cancer Treatment.

  • HR Positive/ HER2 Negative Breast Cancer key companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.

  • HR Positive/ HER2 Negative Breast Cancer Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type. 

  • Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the HR Positive/ HER2 Negative Breast Cancer market.

The report is built using data and information traced from the researcher’s proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations, and featured press releases from company/university websites and industry-specific third-party sources, etc.

 

Download Sample PDF Report to know more about HR Positive/ HER2 Negative Breast Cancer drugs and therapies

 

HR Positive/ HER2 Negative Breast Cancer Pipeline Market Drivers

  • Rising incidence of Breast Cancer, increase in Research and Development activities are some of the important factors that are fueling the HR Positive/ HER2 Negative Breast Cancer Market.

 

HR Positive/ HER2 Negative Breast Cancer Pipeline Market Barriers

  • However, high cost associated with the treatment, side effects associated with the treatment and other factors are creating obstacles in the HR Positive/ HER2 Negative Breast Cancer Market growth.

 

Scope of HR Positive/ HER2 Negative Breast Cancer Pipeline Drug Insight    

  • Coverage: Global

  • Key HR Positive/ HER2 Negative Breast Cancer Companies: Seagen Inc., Regor Pharmaceuticals, Verastem Oncology, Olema Pharmaceuticals, Inc, Tyme, Inc., EOC Pharma, CytomX Therapeutics, Daiichi Sankyo, Inc., AstraZeneca, Chia Tai Tianqing Pharmaceutical Group, and others

  • Key HR Positive/ HER2 Negative Breast Cancer Therapies: SGN-B7H4V, RGT-419B, Abemaciclib + VS-6766 + Fulvestrant, OP-1250, SM-88, EOC202, CX-2009, Dato-DXd, Camizestrant + Palbociclib, TQB3616, and others

  • HR Positive/ HER2 Negative Breast Cancer Therapeutic Assessment: HR Positive/ HER2 Negative Breast Cancer current marketed and HR Positive/ HER2 Negative Breast Cancer emerging therapies

  • HR Positive/ HER2 Negative Breast Cancer Market Dynamics: HR Positive/ HER2 Negative Breast Cancer market drivers and HR Positive/ HER2 Negative Breast Cancer market barriers 

 

Request for Sample PDF Report for HR Positive/ HER2 Negative Breast Cancer Pipeline Assessment and clinical trials

 

Table of Contents

1. HR Positive/ HER2 Negative Breast Cancer Report Introduction

2. HR Positive/ HER2 Negative Breast Cancer Executive Summary

3. HR Positive/ HER2 Negative Breast Cancer Overview

4. HR Positive/ HER2 Negative Breast Cancer- Analytical Perspective In-depth Commercial Assessment

5. HR Positive/ HER2 Negative Breast Cancer Pipeline Therapeutics

6. HR Positive/ HER2 Negative Breast Cancer Late Stage Products (Phase II/III)

7. HR Positive/ HER2 Negative Breast Cancer Mid Stage Products (Phase II)

8. HR Positive/ HER2 Negative Breast Cancer Early Stage Products (Phase I)

9. HR Positive/ HER2 Negative Breast Cancer Preclinical Stage Products

10. HR Positive/ HER2 Negative Breast Cancer Therapeutics Assessment

11. HR Positive/ HER2 Negative Breast Cancer Inactive Products

12. Company-University Collaborations (Licensing/Partnering) Analysis

13. HR Positive/ HER2 Negative Breast Cancer Key Companies

14. HR Positive/ HER2 Negative Breast Cancer Key Products

15. HR Positive/ HER2 Negative Breast Cancer Unmet Needs

16 . HR Positive/ HER2 Negative Breast Cancer Market Drivers and Barriers

17. HR Positive/ HER2 Negative Breast Cancer Future Perspectives and Conclusion

18. HR Positive/ HER2 Negative Breast Cancer Analyst Views

19. Appendix

20. About DelveInsight

 

 

About DelveInsight

DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate business growth and overcome challenges with a practical approach.

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