Metastatic Triple Negative Breast Cancer Clinical Trials and Pipeline 2025: EMA, PDMA, FDA Approvals, Medication, NDA Approval, Therapies, ROA, MOA and Companies by DelveInsight

(Albany, United States) "Metastatic Triple Negative Breast Cancer Pipeline Insight, 2025" report by DelveInsight outlines comprehensive insights into the present clinical development scenario and growth prospects across the Metastatic Triple Negative Breast Cancer Market.

As per DelveInsight's assessment, globally, Metastatic Triple Negative Breast Cancer pipeline constitutes 10+ key companies continuously working towards developing 12+ Metastatic Triple Negative Breast Cancer treatment therapies, analysis of Clinical Trials, Therapies, Mechanism of Action, Route of Administration, and Developments analyzes DelveInsight.

The Metastatic Triple 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.

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Some of the key takeaways from the Metastatic Triple Negative Breast Cancer Pipeline Report:
• Metastatic Triple Negative Breast Cancer Clinical Trials Companies across the globe are diligently working toward developing novel Metastatic Triple Negative Breast Cancer treatment therapies with a considerable amount of success over the years.
• Metastatic Triple Negative Breast Cancer companies working in the treatment market are G1 Therapeutics, AstraZeneca, OncoPep, and others, are developing therapies for the Metastatic Triple Negative Breast Cancer treatment
• Emerging Metastatic Triple Negative Breast Cancer therapies in the different phases of clinical trials are- COSELA (trilacicilib), Datopotamab deruxtecan (Dato-DXd), PVX-410, and others are expected to have a significant impact on the Metastatic Triple Negative Breast Cancer market in the coming years.
• In January 2025, The Novotech Triple Negative Breast Cancer Clinical Trial Report emphasized ongoing drug development at various stages, with 78 trials in Phase I, 97 in Phase II, and 12 in Phase III. Notable advancements include targeted therapies like PARP inhibitors, immune checkpoint inhibitors (ICIs), and novel antibody-drug conjugates (ADCs). Furthermore, combination strategies involving immunotherapy, chemotherapy, and targeted treatments are enhancing overall treatment efficacy.
• In November 2024, A new treatment approach developed at Roswell Park Comprehensive Cancer Center showed promising results in a Phase 1 clinical trial for patients with triple-negative breast cancer (TNBC), the most aggressive type of the disease.
• In February 2024, G1 Therapeutics reported that the independent Data Monitoring Committee (DMC) has recommended the continuation of the Phase 3 trial (PRESERVE 2) of trilaciclib in combination with gemcitabine and carboplatin for initial treatment of metastatic triple-negative breast cancer (mTNBC) until final analysis. The analysis, focusing on Overall Survival (OS) in the intent-to-treat (ITT) population, is anticipated by Q3 2024. The DMC did not identify any safety issues and did not propose any modifications to the study. G1 Therapeutics remains blinded to the data as the interim analysis did not meet early stopping criteria.
• In May 2023, Shanghai Junshi Biosciences Co., Ltd. announced that the National Medical Products Administration has accepted the supplemental new drug application (sNDA) for toripalimab, an anti-PD-1 monoclonal antibody. This application seeks approval for its use alongside albumin-bound paclitaxel to treat untreated metastatic or recurrent metastatic triple-negative breast cancer with PD-L1 positivity (CPS ≥ 1).

Metastatic Triple Negative Breast Cancer Overview
Metastatic Triple Negative Breast Cancer (mTNBC) is an advanced form of breast cancer that lacks three key receptors commonly found in other types of breast cancer: estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor 2 (HER2). This absence of receptors makes mTNBC more challenging to treat because it does not respond to hormonal therapies or HER2-targeted treatments.

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Emerging Metastatic Triple Negative Breast Cancer Drugs Under Different Phases of Clinical Development Include:
• COSELA (trilacicilib): G1 Therapeutics
• Datopotamab deruxtecan (Dato-DXd): AstraZeneca
• PVX-410: OncoPep
• LY3023414: Eli Lilly and Company
• Niraparib: Tesaro, Inc.
• Pembrolizumab: Merck Sharp & Dohme LLC
• Sacituzumab Govitecan: Gilead Sciences
• NBE-002: NBE-Therapeutics AG
• L-NMMA: Novartis Pharmaceuticals
• Imprime PGG : HiberCell
• TECENTRIQ: Hoffmann-La Roche
• IPI-549: Infinity Pharmaceuticals
• Leronlimab (PRO 140): CytoDyn
• MDNA11: Medicenna Therapeutics
• ASTX727: Astex Pharmaceuticals, Inc.
• AG-01: A&G Pharmaceutical Inc.
• ZEN003694: Zenith Epigenetics
• AL101: Ayala Pharmaceuticals, Inc.
• PMD-026: Phoenix Molecular Designs
• CDX-1140: Celldex Therapeutics

Metastatic Triple Negative Breast Cancer Route of Administration
Metastatic Triple 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
• Oral
• Parenteral
• Intravenous
• Subcutaneous
• Topical

Metastatic Triple Negative Breast Cancer Molecule Type
Metastatic Triple Negative Breast Cancer Products have been categorized under various Molecule types, such as
• Monoclonal Antibody
• Peptides
• Polymer
• Small molecule
• Gene therapy

Metastatic Triple Negative Breast Cancer Pipeline Therapeutics Assessment
• Metastatic Triple Negative Breast Cancer Assessment by Product Type
• Metastatic Triple Negative Breast Cancer By Stage and Product Type
• Metastatic Triple Negative Breast Cancer Assessment by Route of Administration
• Metastatic Triple Negative Breast Cancer By Stage and Route of Administration
• Metastatic Triple Negative Breast Cancer Assessment by Molecule Type
• Metastatic Triple Negative Breast Cancer by Stage and Molecule Type

DelveInsight's Metastatic Triple Negative Breast Cancer Report covers around 12+ 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 Metastatic Triple Negative Breast Cancer product details are provided in the report. Download the Metastatic Triple Negative Breast Cancer pipeline report to learn more about the emerging Metastatic Triple Negative Breast Cancer therapies
https://www.delveinsight.com/sample-request/metastatic-triple-negative-breast-cancer-mtnbc-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr

Some of the key companies in the Metastatic Triple Negative Breast Cancer Therapeutics Market include:
Key companies developing therapies for Metastatic Triple Negative Breast Cancer are - Zenith Epigenetics, BioLite, Inc., Abbisko Therapeutics, Phoenix Molecular Designs, OncoTherapy Science, ModernaTX, Inc, NuGenrex Immuno-Oncology, Pfizer, Jiangsu Alphamab Biopharmaceuticals Co., Ltd., BioLite, Inc., ImmunityBio, Inc., PharmAbcine, Genexine, Inc., Shanghai Henlius Biotech, Jiangsu HengRui Medicine Co., Ltd., G1 Therapeutics, Inc., Infinity Pharmaceuticals, HiberCell, Inc., CSPC ZhongQi Pharmaceutical Technology Co., Ltd., Novartis Pharmaceuticals, Klus Pharma, Ayala Pharmaceuticals, Inc, Akeso Biopharma, Chipscreen Biosciences, OncoPep, Inc., Iovance Biotherapeutics, Inc., SynDevRx, Inc., Hoffmann-La Roche, Celcuity, Inc., Amgen, AstraZeneca, NBE-Therapeutics AG, Fusion Pharmaceuticals, Immutep Limited, and others.

Metastatic Triple Negative Breast Cancer Pipeline Analysis:
The Metastatic Triple Negative Breast Cancer pipeline report provides insights into
• The report provides detailed insights about companies that are developing therapies for the treatment of Metastatic Triple 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 Metastatic Triple Negative Breast Cancer Treatment.
• Metastatic Triple Negative Breast Cancer key companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
• Metastatic Triple 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 Metastatic Triple 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 Metastatic Triple Negative Breast Cancer drugs and therapies
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Metastatic Triple Negative Breast Cancer Pipeline Market Strengths
• Recent approvals of PD-1/PD-L1 and PARP inhibitors in frontline treatment have significantly improved patient prognosis.
• Entry of the new ADC TRODELVY in the market has also presented itself as an effective treatment option for people progressing from prior lines of therapy.

Metastatic Triple Negative Breast Cancer Pipeline Market Opportunities
• Identification of additional potentially targetable biomarkers and their effective targeting by novel molecules could significantly improve patient outcomes in patients with low expression of known targetable biomarkers like PD-L1 and germline BRCA1/2 mutations.
• TNBC is a group of diseases, which, with further research and upon improved understanding, is set to be subclassified, which would, in turn, improve treatment allocation and patient prognosis

Scope of Metastatic Triple Negative Breast Cancer Pipeline Drug Insight
• Coverage: Global
• Key Metastatic Triple Negative Breast Cancer Companies: G1 Therapeutics, AstraZeneca, OncoPep, and others
• Key Metastatic Triple Negative Breast Cancer Therapies: COSELA (trilacicilib), Datopotamab deruxtecan (Dato-DXd), PVX-410, and others
• Metastatic Triple Negative Breast Cancer Therapeutic Assessment: Metastatic Triple Negative Breast Cancer current marketed and Metastatic Triple Negative Breast Cancer emerging therapies
• Metastatic Triple Negative Breast Cancer Market Dynamics: Metastatic Triple Negative Breast Cancer market drivers and Metastatic Triple Negative Breast Cancer market barriers

Request for Sample PDF Report for Metastatic Triple Negative Breast Cancer Pipeline Assessment and clinical trials
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Table of Contents
1. Metastatic Triple Negative Breast Cancer Report Introduction
2. Metastatic Triple Negative Breast Cancer Executive Summary
3. Metastatic Triple Negative Breast Cancer Overview
4. Metastatic Triple Negative Breast Cancer- Analytical Perspective In-depth Commercial Assessment
5. Metastatic Triple Negative Breast Cancer Pipeline Therapeutics
6. Metastatic Triple Negative Breast Cancer Late Stage Products (Phase II/III)
7. Metastatic Triple Negative Breast Cancer Mid Stage Products (Phase II)
8. Metastatic Triple Negative Breast Cancer Early Stage Products (Phase I)
9. Metastatic Triple Negative Breast Cancer Preclinical Stage Products
10. Metastatic Triple Negative Breast Cancer Therapeutics Assessment
11. Metastatic Triple Negative Breast Cancer Inactive Products
12. Company-University Collaborations (Licensing/Partnering) Analysis
13. Metastatic Triple Negative Breast Cancer Key Companies
14. Metastatic Triple Negative Breast Cancer Key Products
15. Metastatic Triple Negative Breast Cancer Unmet Needs
16 . Metastatic Triple Negative Breast Cancer Market Drivers and Barriers
17. Metastatic Triple Negative Breast Cancer Future Perspectives and Conclusion
18. Metastatic Triple Negative Breast Cancer Analyst Views
19. Appendix
20. About DelveInsight

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