Metastatic Triple-Negative Breast Cancer (mTNBC)- Pipeline Insight, 2025

DelveInsight’s, “Metastatic Triple-Negative Breast Cancer (mTNBC)- Pipeline Insight, 2025” report provides comprehensive insights about 10+ companies and 12+ pipeline drugs in Metastatic Triple-Negative Breast Cancer (mTNBC) 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

Metastatic Triple-Negative Breast Cancer (mTNBC): Understanding

Metastatic Triple-Negative Breast Cancer (mTNBC): Overview

Metastatic triple-negative breast cancer (mTNBC) represents one of the most aggressive and challenging subtypes of breast cancer, characterized by its poor prognosis and limited treatment options. While chemotherapy remains the standard of care, no agents are specifically approved for mTNBC. Recently, the combination of atezolizumab and nab-paclitaxel received approval for PD-L1-positive locally advanced or metastatic TNBC, marking a significant advancement.

Metastatic triple-negative breast cancer (mTNBC) manifests various symptoms based on metastasis location. Common symptoms include pain (bones, liver, lungs), severe fatigue, and unintended weight loss (liver, digestive system). Lung metastasis can cause shortness of breath and persistent coughing, sometimes with blood. Liver metastasis may lead to abdominal pain, jaundice, and changes in bowel or bladder habits. Brain or spinal cord spread can result in numbness, weakness, and occasionally seizures.

Metastatic triple-negative breast cancer (mTNBC) is a challenging subtype lacking hormonal receptors and HER2 expression, leading to poor outcomes, especially after residual disease post-neoadjuvant chemotherapy. Adding cisplatin or carboplatin to neoadjuvant treatment has shown improved pathological complete response rates, particularly in BRCA1 mutation patients. Molecular subtyping of TNBC can tailor treatments, with different subtypes responding variably to chemotherapy. Understanding TNBC heterogeneity and subtyping may lead to more effective strategies, targeting DNA repair, immunomodulation, hormone receptors, and signaling pathways to improve mTNBC outcomes.

Metastatic triple-negative breast cancer (mTNBC) is an aggressive form of breast cancer characterized by the absence of estrogen receptors (ER), progesterone receptors (PR), and the lack of excess HER2 protein. This subtype represents about 10-15% of all breast cancers and is particularly challenging to treat due to its lack of targeted therapies, often leading to poorer prognosis compared to other breast cancer types. mTNBC typically spreads more quickly than hormone receptor-positive breast cancers and is more likely to recur after treatment. Diagnosis involves a combination of imaging studies, biopsy, and immunohistochemically testing to confirm the triple-negative status and assess the extent of metastasis, which commonly affects the lungs, liver, brain, and bones. Treatment options are generally limited to chemotherapy, immunotherapy, and participation in clinical trials exploring new therapeutic approaches. Metastatic triple-negative breast cancer (mTNBC) is a highly aggressive form of breast cancer characterized by the lack of estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor 2 (HER2). Standard treatments for mTNBC include chemotherapy with anthracyclines and taxanes, while therapies targeting ER, PR, and HER2 are ineffective. New treatment strategies such as targeted drugs, immunotherapy, and novel chemotherapy agents are being developed to address the challenges of mTNBC.

""Metastatic Triple-Negative Breast Cancer (mTNBC)- Pipeline Insight, 2025"" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Metastatic Triple-Negative Breast Cancer (mTNBC) pipeline landscape is provided which includes the disease overview and Metastatic Triple-Negative Breast Cancer (mTNBC) treatment guidelines. The assessment part of the report embraces, in depth Metastatic Triple-Negative Breast Cancer (mTNBC) commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Metastatic Triple-Negative Breast Cancer (mTNBC) collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights

• The companies and academics are working to assess challenges and seek opportunities that could influence Metastatic Triple-Negative Breast Cancer (mTNBC) R&D. The therapies under development are focused on novel approaches to treat/improve Metastatic Triple-Negative Breast Cancer (mTNBC).

Metastatic Triple-Negative Breast Cancer (mTNBC) Emerging Drugs Chapters

This segment of the Metastatic Triple-Negative Breast Cancer (mTNBC) report encloses its detailed analysis of various drugs in different stages of clinical development, including phase III, II, II/III 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.

Metastatic Triple-Negative Breast Cancer (mTNBC) Emerging Drugs

• Trilaciclib: G1 Therapeutics

Trilaciclib, an IV-administered transient CDK4/6 inhibitor, is a first-in-class therapy designed to preserve bone marrow and immune system function during cytotoxic therapy to improve patient outcomes. PRESERVE 2 is a global, multi-center, randomized placebo-controlled, line extension pivotal Phase 3 trial of trilaciclib in patients with locally advanced unresectable or metastatic TNBC. Patients meeting eligibility requirements were randomized 1:1 to receive either trilaciclib or placebo administered prior to first-line gemcitabine and carboplatin (GCb). The regimen is given intravenously (IV) on Days 1 and 8 in 21-day cycles. Treatment is administered until disease progression. The drug is currently being investigated in the Phase III stage of development for the treatment of Metastatic Triple-Negative Breast Cancer (mTNBC).

• Olinvacimab: PharmAbcine/Merck

Olinvacimab is an anti-angiogenic antibody that neutralizes the VEGF/VEGFR2 pathway, thus inhibiting tumor growth and metastasis. It blocks the binding of all VEGFR ligands such as VEGF-A, VEGF-C and VEGF-D to VEGFR2. To gain nutrients and oxygen needed for growth, tumor cells release these VEGF ligands which promote angiogenesis (a formation of new blood vessels) that will enhance tumor blood supply. Binding of olinvacimab to VEGFR2 will result in the inhibition of VEGF-mediated tumor angiogenesis. PharmAbcine had multiple ongoing global clinical trials involving Olinvacimab. Other than the ongoing Phase 2a Olinvacimab and Pembrolizumab combo trial in mTNBC, which had the first patient dosed in December 2021, a Phase 2a Olinvacimab mono study for Bevacizumab-nonresponding rGBM (recurrent glioblastoma multiforme) patients is ongoing at multiple sites in both US and Australia. Currently, the drug is in Phase II satge of its clinical trial for the treatment of Metastatic Triple-Negative Breast Cancer (mTNBC).

Further product details are provided in the report……..

Metastatic Triple-Negative Breast Cancer (mTNBC): Therapeutic Assessment

This segment of the report provides insights about the different Metastatic Triple-Negative Breast Cancer (mTNBC) drugs segregated based on following parameters that define the scope of the report, such as:

• Major Players in Metastatic Triple-Negative Breast Cancer (mTNBC)

There are approx. 10+ key companies which are developing the therapies for Metastatic Triple-Negative Breast Cancer (mTNBC). The companies which have their Metastatic Triple-Negative Breast Cancer (mTNBC) drug candidates in the most advanced stage, i.e. Phase III include, G1 Therapeutics.

• Phases

DelveInsight’s 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) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates
• Route of Administration

Metastatic Triple-Negative Breast Cancer (mTNBC) pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

• Intravenous
• Subcutaneous
• Oral
• Intramuscular
• Molecule Type

Products have been categorized under various Molecule types such as

• Monoclonal antibody
• Small molecule
• Peptide
• Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Metastatic Triple-Negative Breast Cancer (mTNBC): Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Metastatic Triple-Negative Breast Cancer (mTNBC) therapeutic drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Metastatic Triple-Negative Breast Cancer (mTNBC) drugs.

Metastatic Triple-Negative Breast Cancer (mTNBC) Report Insights

• Metastatic Triple-Negative Breast Cancer (mTNBC) Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Metastatic Triple-Negative Breast Cancer (mTNBC) Report Assessment

• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Metastatic Triple-Negative Breast Cancer (mTNBC) drugs?
• How many Metastatic Triple-Negative Breast Cancer (mTNBC) drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Metastatic Triple-Negative Breast Cancer (mTNBC)?
• What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the Metastatic Triple-Negative Breast Cancer (mTNBC) therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Metastatic Triple-Negative Breast Cancer (mTNBC) and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• G1 Therapeutics
• Daiichi Sankyo
• PharmAbcine/Merck
• Rhizen Pharmaceuticals
• CytoDyn
• SBGBL

Key Products

• Trilaciclib
• Datopotamab deruxtecan
• Olinvacimab
• Tenalisib
• Leronlimab (PRO 140)
• Sathgen Therapeutics