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Triple-Negative Breast Cancer Clinical Trial Landscape Expands With 170+ Pipeline Assets, According to DelveInsight

02-17-2026 02:43 AM CET | Health & Medicine

Press release from: DelveInsight Business Research

Triple-Negative Breast Cancer Clinical Trial

Triple-Negative Breast Cancer Clinical Trial

An expanding portfolio of novel therapies for triple-negative breast cancer (TNBC) including TECENTRIQ (Hoffmann-La Roche), IPI-549 (Infinity Pharmaceuticals), Leronlimab (CytoDyn), MDNA11 (Medicenna Therapeutics), VIP236 (Vincerx Pharma), and CFI-400945 (Treadwell Therapeutics) is anticipated to significantly influence market expansion and transform the TNBC treatment landscape.

DelveInsight's Triple Negative Breast Cancer Pipeline Insight report offers an extensive evaluation of more than 165 companies and over 170 therapeutic candidates advancing through the TNBC pipeline. The publication provides in-depth drug profiles across clinical and preclinical phases, assessing candidates by product type, stage of development, route of administration, and molecular structure. It also highlights inactive and discontinued programs within the TNBC domain.
Based on DelveInsight's findings, the TNBC therapeutics market is projected to witness substantial growth in the foreseeable future. Market expansion is expected to be fueled by rising incidence rates, technological progress in diagnostics, growing awareness, increased global healthcare expenditure, and the anticipated introduction of innovative treatments.
The steady increase in TNBC prevalence has intensified the need for more effective therapeutic solutions. A growing patient pool, along with rising investments in research and development of next-generation treatments, is likely to drive further market acceleration. Multiple organizations, including Jiangsu HengRui Medicine, G1 Therapeutics, Infinity Pharmaceuticals, and others, are progressing late-stage pipeline candidates in TNBC.

To learn more about the TNBC Pipeline Report features and emerging trends, request a complimentary sample of the Triple Negative Breast Cancer Drug Pipeline Analysis @ https://www.delveinsight.com/report-store/triple-negative-breast-cancer-tnbc-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr

Major Updates Featured in the TNBC Pipeline Report
• February 2026, AstraZeneca and Daiichi Sankyo's supplemental Biologics License Application (sBLA) for Datroway (datopotamab deruxtecan) has been accepted and granted Priority Review in the US for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy.
• January 2026: Kazia Therapeutics (NASDAQ: KZIA) shared a clinical update from its ongoing Phase Ib trial evaluating paxalisib combined with pembrolizumab and chemotherapy in patients with advanced (Stage IV) metastatic TNBC.
• November 2025: Akeso (9926.HK) announced that its innovative PD-1/VEGF bispecific antibody, ivonescimab, in combination with chemotherapy for first-line TNBC treatment, received Breakthrough Therapy Designation from China's National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE).
• November 2025: Kazia Therapeutics Limited (Nasdaq: KZIA) reported that a Stage IV TNBC patient treated under an FDA-approved expanded access protocol - combining paxalisib with pembrolizumab (Keytruda®) and standard chemotherapy - achieved an initial immune-complete response (iCR) per iRECIST criteria, demonstrating a notable radiologic response in aggressive metastatic disease.
• June 2025: Cardiff Oncology, Inc. (Nasdaq: CRDF) presented encouraging results from an investigator-sponsored Phase Ib study evaluating onvansertib plus paclitaxel in metastatic TNBC patients at the 2025 ASCO Annual Meeting in Chicago.
• June 2025: Cellectar Biosciences, Inc. (Nasdaq: CLRB) submitted a Phase Ib dose-escalation study protocol to the U.S. FDA for CLR 125, an iodine-125 Auger-emitting radiopharmaceutical, targeting relapsed TNBC and other solid tumors.
• May 2025: AstraZeneca launched a Phase III trial investigating capivasertib in combination with paclitaxel versus placebo plus paclitaxel as first-line therapy for patients with locally advanced or metastatic TNBC.
• May 2025: MedSIR initiated a Phase II study aimed at enhancing the tolerability profile of sacituzumab govitecan in advanced or metastatic TNBC patients who are refractory to prior chemotherapy.
• May 2025: Merck Sharp & Dohme LLC conducted a comparative trial evaluating adjuvant sacituzumab tirumotecan (MK-2870) plus pembrolizumab against physician's choice treatment in TNBC patients who did not achieve pathological complete response following neoadjuvant therapy.
• DelveInsight's TNBC pipeline assessment highlights a dynamic landscape with 165+ active stakeholders developing over 170 investigational therapies.
• Leading TNBC companies include G1 Therapeutics, Gilead Sciences, Biotheus Inc., GlaxoSmithKline, Hoffmann-La Roche, AstraZeneca, Novartis Pharmaceuticals, Akeso Biopharma, Merck & Co., Bristol-Myers Squibb, Pfizer, Eli Lilly and Company, Amgen, Genmab, ModernaTX, AbbVie, BeiGene, Genentech, and numerous other global innovators advancing therapeutic research.
• Prominent pipeline candidates encompass Trilaciclib, Sacituzumab Govitecan + Pembrolizumab, PM8002, Niraparib, Ipatasertib, Capivasertib, Camrelizumab, Olaparib, Patritumab deruxtecan, Enfortumab vedotin, Onvansertib, MDNA11, and a wide array of additional monoclonal antibodies, antibody-drug conjugates (ADCs), small molecules, immunotherapies, and cellular therapies in development.

Stay informed with the latest TNBC pipeline developments. Access comprehensive insights into clinical trials, emerging treatments, and key industry players with DelveInsight's Triple Negative Breast Cancer Treatment Drugs analysis @ https://www.delveinsight.com/report-store/triple-negative-breast-cancer-tnbc-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr

Triple Negative Breast Cancer Emerging Therapies
• Trilaciclib (G1 Therapeutics): A short-duration intravenous CDK4/6 inhibitor designed to preserve bone marrow and immune function during chemotherapy; currently undergoing Phase III evaluation in TNBC.
• Olaparib (AstraZeneca): An oral PARP inhibitor approved for BRCA-mutated TNBC that has demonstrated extended progression-free survival and continues to be explored in combination regimens.
• Patritumab Deruxtecan (Daiichi Sankyo/Merck): A HER3-directed antibody-drug conjugate showing promising activity in HER3-positive TNBC, presently in Phase II trials.
• NUV-868 (Nuvation Bio): A BET inhibitor in Phase I/II development, with strategies being refined to optimize combination approaches.
• TUB-030 (Tubulis): A next-generation 5T4-targeting ADC leveraging proprietary conjugation technology, currently in preclinical stages.

Key Insights Delivered in the TNBC Pipeline Report
• Detailed profiling of organizations developing TNBC therapeutics and their respective portfolios
• Categorization of pipeline candidates across early, mid, and late clinical phases
• Assessment of targeted therapies, including both active and discontinued programs
• Comprehensive analysis by development stage, administration method, molecular type, mechanism of action, and combination strategy
• Thorough review of collaborations, licensing deals, and financial activities supporting pipeline progression

Discover cutting-edge therapies and ongoing clinical trials within the TNBC pipeline. Access DelveInsight's comprehensive report today @ https://www.delveinsight.com/sample-request/triple-negative-breast-cancer-tnbc-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr

Triple Negative Breast Cancer Routes of Administration
• Intravenous
• Subcutaneous
• Oral
• Intramuscular

Triple Negative Breast Cancer Molecule Types
• Monoclonal antibodies
• Small molecules
• Peptides

Gain insights into the future of TNBC treatment. Explore novel drug candidates, pipeline advancements, and major industry contributors with DelveInsight's expert evaluation of TNBC market drivers and barriers @ https://www.delveinsight.com/sample-request/triple-negative-breast-cancer-tnbc-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr

Scope of the TNBC Pipeline Report
• Geographic Coverage: Worldwide
• Active Companies: 165+
• Pipeline Candidates: 170+
• Treatment Approaches: Monotherapies and combination regimens
• Clinical Phases: Discovery through Phase III

Stay updated on TNBC therapies and clinical research advancements. Download DelveInsight's comprehensive pipeline report covering companies, key products, and unmet needs @ https://www.delveinsight.com/sample-request/triple-negative-breast-cancer-tnbc-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr

Table of Contents
1. Introduction
2. TNBC Executive Overview
3. TNBC Disease Overview
4. TNBC Pipeline Therapeutics
5. Therapeutic Evaluation
6. DelveInsight's Analytical Perspective
7. Late-Stage (Phase III) Products
8. Camrelizumab: Jiangsu HengRui Medicine
9. Detailed Drug Profiles
10. Mid-Stage (Phase II) Products
11. AK117: Akeso Biopharma
12. Detailed Drug Profiles
13. Early-Stage (Phase I) Products
14. PMD-026: Phoenix Molecular Designs
15. Detailed Drug Profiles
16. Inactive Programs
17. TNBC Companies
18. TNBC Products
19. TNBC Unmet Needs
20. TNBC Market Drivers and Barriers
21. Future Outlook and Conclusion
22. Analyst Perspectives
23. Key Companies
24. Appendix

Contact Us:
Ankit Nigam
Manager Marketing
info@delveinsight.com
+14699457679

About DelveInsight
DelveInsight is a leading Life Science market research and business consulting company recognized for its off-the-shelf syndicated market research reports and customized solutions to firms in the healthcare sector.

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