ER+/HER2- Breast Cancer Pipeline: 20+ Leading Companies Pioneering Innovative Therapies | DelveInsight

The ER+/HER2-ve breast cancer market is rapidly advancing and is fueled by groundbreaking research and innovative therapies from companies such as Olema Pharmaceuticals, Eli Lilly and Company, Novartis Pharmaceuticals, Hoffmann-La Roche, and Ellipses Pharma. These industry pioneers are transforming treatment strategies and redefining the future of ER+/HER2-ve breast cancer , bringing new hope to patients worldwide.

DelveInsight's "ER+/HER2-ve Breast Cancer Pipeline Insight, 2025" comprehensively analyzes the current clinical landscape and growth prospects in the ER+/HER2-ve Breast Cancer market. The report covers disease insights, treatment guidelines, and a detailed pipeline assessment from preclinical to marketed stages. It includes drug mechanisms, clinical studies, regulatory progress, and key developments such as collaborations, mergers, funding, and designations.

For emerging ER+/HER2-ve breast cancer drugs, the ER+/HER2-ve Breast Cancer pipeline analysis report provides a 360° view of the therapeutics landscape by development point, product type, route of administration, molecule type, and MOA. The pipeline research covers business opportunities, challenges, future partnerships, strong competitors, and growth strategies.

Key Takeaways from the ER+/HER2-ve Breast Cancer Pipeline Report
• DelveInsight's ER+/HER2-ve breast cancer pipeline analysis depicts a robust space with 20+ active players working to develop 25+ pipeline drugs for ER+/HER2-ve Breast Cancer treatment.
• The leading ER+/HER2-ve breast cancer companies include AstraZeneca, Atossa Therapeutics, Inc., Accutar Biotechnology Inc, VelosBio Inc, Merus N.V., Pfizer, Olema Pharmaceuticals, Inc., Eli Lilly and Company, Novartis Pharmaceuticals, Hoffmann-La Roche, Ellipses Pharma, BeiGene, and others are evaluating their lead assets to improve the ER+/HER2-ve Breast Cancer treatment landscape.
• Key ER+/HER2-ve breast cancer pipeline therapies in various stages of development include Camizestrant, (Z)-endoxifen, AC699, Zilovertamab vedotin, Zenocutuzumab, PD0332991, Palazestrant, LY3484356, Letrozole, Ipatasertib, EP0062, BGB-290, and others.
• In February 2025, the FDA granted Lumitron Technologies, Inc. "Breakthrough Device" designation for its HyperVIEWTM X-Ray system, which uses the K-Edge subtraction technique to enable contrast-enhanced imaging for breast cancer diagnosis. This technology utilizes Lumitron's proprietary distributed charge laser-Compton technology, offering 100 times higher resolution and significantly safer imaging compared to standard X-rays.
• In January 2025, the FDA approved AstraZeneca (AZN.L) and Daiichi Sankyo's (4568.T) precision drug, Datroway, for treating advanced breast cancer in patients who have received prior treatment.
• In Dec 2024, ScreenPoint Medical showcased new FDA clearance for advanced capabilities of its leading Breast AI, Transpara, at the 110th Annual Radiological Society of North America (RSNA) meeting (December 1-4, 2024, South Hall #5316). Transpara, the most clinically validated Breast AI on the market, assists radiologists in detecting cancers earlier and reducing recall rates.
In October 2024, Genentech announced that the FDA approved ItovebiTM (inavolisib), in combination with palbociclib (Ibrance®) and fulvestrant, for treating adults with endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative, locally advanced or metastatic breast cancer, following recurrence after adjuvant endocrine therapy.

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ER+/HER2-ve Breast Cancer Overview
ER-positive, HER2-negative breast cancer is a common subtype in which cancer cells have estrogen receptors (ER-positive) but lack excess HER2 protein. It primarily affects postmenopausal women but can also occur in younger women. These tumors grow in response to estrogen, making hormone therapy a key part of treatment.
Symptoms are similar to other breast cancers and include a breast lump, changes in size or shape, skin dimpling, or pain. Early stages may be asymptomatic, highlighting the importance of routine screening.
While the exact cause is unknown, risk factors include prolonged estrogen exposure (early menstruati0n, late menopause, hormone therapy), age, family history, BRCA mutations, alcohol use, and obesity.
Diagnosis involves imaging (mammogram, ultrasound, MRI) followed by a biopsy. Immunohistochemistry (IHC) testing confirms hormone and HER2 receptor status.
Treatment typically includes surgery (lumpectomy or mastectomy), radiation, and systemic therapy. Hormone therapy (e.g., tamoxifen, aromatase inhibitors) is central, often combined with chemotherapy in high-risk cases. Emerging targeted therapies and clinical trials continue to advance treatment options.

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ER+/HER2-ve Breast Cancer Treatment Analysis: Drug Profile
Camizestrant: AstraZeneca
Camizestrant is a next-generation oral selective estrogen receptor degrader (SERD) being developed by AstraZeneca for ER-positive, HER2-negative breast cancer. It has shown promising efficacy in improving progression-free survival (PFS) over fulvestrant, the standard SERD therapy for nearly two decades. In the Phase II SERENA-2 trial, camizestrant demonstrated superior PFS at both 75 mg (7.2 months) and 150 mg (9.2 months) doses, compared to 3.7 months for fulvestrant. Additionally, camizestrant significantly reduced ESR1-mutant circulating tumor DNA, suggesting strong activity against endocrine-resistant tumors. The drug has a favorable safety profile, with mostly manageable side effects such as fatigue, anemia, and mild visual disturbances. Currently in Phase III trials (SERENA-4 and SERENA-6), camizestrant is being studied both as monotherapy and in combination with CDK4/6 inhibitors.

(Z)-endoxifen: Atossa Therapeutics, Inc.
(Z)-endoxifen is the most potent active metabolite of tamoxifen, a widely used selective estrogen receptor modulator (SERM). Atossa Therapeutics is developing a proprietary oral formulation of (Z)-endoxifen that bypasses liver metabolism and stomach acidity to maintain therapeutic potency. Unlike tamoxifen, (Z)-endoxifen exerts stronger anti-estrogen effects and also inhibits PKCβ1, an oncogenic protein, at higher concentrations. It offers similar or enhanced bone-protective benefits with reduced risk of endometrial proliferation. Phase I and early Phase II trials have shown the drug to be well tolerated. (Z)-endoxifen is currently in Phase II development for ER-positive, HER2-negative breast cancer.

Key ER+/HER2-ve Breast Cancer Therapies and Companies
• Camizestrant (AZD9833): AstraZeneca
• (Z)-endoxifen: Atossa Therapeutics, Inc.
• AC699: Accutar Biotechnology Inc
• Enobosarm: Veru
• Amcenestrant (SAR439859): Sanofi
• Giredestrant (RG6171, GDC-9545): Roche
• LY3484356/Imlunestrant: Eli Lilly
• Lerociclib: EQRx
• TRODELVY (sacituzumab govitecan): Gilead
• Capivasertib: AstraZeneca
• Lasofoxifene: Sermonix Pharmaceuticals
• SFX-01: Evgen Pharma
• SM-88: Tyme
• Inavolisib: Roche/Genentech
• Datopotamab deruxtecan (Dato-DXd): AstraZeneca and Daiichi Sankyo

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ER+/HER2-ve Breast Cancer Therapeutics Assessment
By Product Type
• Mono
• Combination
• Mono/Combination.

By Stage
• Late-stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

By Route of Administration
• Intravenous
• Subcutaneous
• Oral
• Intramuscular

By Molecule Type
• Monoclonal antibody
• Small molecule
• Peptide

Scope of the ER+/HER2-ve Breast Cancer Pipeline Report
• Coverage: Global
• Key ER+/HER2-ve Breast Cancer Companies: AstraZeneca, Atossa Therapeutics, Inc., Accutar Biotechnology Inc, VelosBio Inc, Merus N.V., Pfizer, Olema Pharmaceuticals, Inc., Eli Lilly and Company, Novartis Pharmaceuticals, Hoffmann-La Roche, Ellipses Pharma, BeiGene, and others.
• Key ER+/HER2-ve Breast Cancer Pipeline Therapies: Camizestrant, (Z)-endoxifen, AC699, Zilovertamab vedotin, Zenocutuzumab, PD0332991, Palazestrant, LY3484356, Letrozole, Ipatasertib, EP0062, BGB-290, and others.

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Table of Contents
1. Introduction
2. Executive Summary
3. ER+/HER2-ve Breast Cancer Pipeline: Overview
4. Analytical Perspective In-depth Commercial Assessment
5. ER+/HER2-ve Breast Cancer Pipeline Therapeutics
6. ER+/HER2-ve Breast Cancer Pipeline: Late-Stage Products (Phase III)
7. ER+/HER2-ve Breast Cancer Pipeline: Late-Stage Products (Phase III)
8. ER+/HER2-ve Breast Cancer Pipeline: Mid-Stage Products (Phase II)
9. ER+/HER2-ve Breast Cancer Pipeline: Early Stage Products (Phase I)
10. Therapeutic Assessment
11. Inactive Products
12. Company-University Collaborations (Licensing/Partnering) Analysis
13. Key Companies
14. Key Products
15. Unmet Needs
16. Market Drivers and Barriers
17. Future Perspectives and Conclusion
18. Analyst Views
19. Appendix

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