TROP2 (trophoblast cell surface antigen 2) has recently gained prominence as target for cancer therapies due to its overexpression in a range of epithelial cancers, such as breast, lung, and urothelial cancers. This membrane protein, crucial for cell growth and survival, presents an appealing target for innovative treatments, especially antibody-drug conjugates (ADCs), which dominate the development pipeline. The landscape for TROP2- targeted therapies has experienced rapid evolution, marked by significant advancements and growing interest in harnessing this biomarker for more effective cancer treatment.
Currently, only one drug targeting TROP2 has been approved, namely Trodelvy (sacituzumab govitecan). Developed by Immunomedics (now part of Gilead Sciences), it received FDA approval in April 2020 for triple negative breast cancer and had its indication expanded to urothelial cancer in April 2021. As of August 2024, Trodelvy is approved in around 50 countries.
Trodelvy's commercial success is evident from its significant sales growth. In the first half of 2024, sales jumped over 30% to surpass USD 600 million compared to the same period in 2023, driven mainly by increased demand for treatments in second-line metastatic triple-negative breast cancer and pre-treated HR+/HER2- metastatic breast cancer.
Global TROP2 Antibody Market & Clinical Trials Insight 2029 Report Offering:
- Global TROP2 Antibody Market Opportunity: > USD 3 Billion
- Global & Regional Market Insight
- Approved Drug Annual & Quarterly Sales By Region
- Approved Drug Dosage & Pricing Insight
- TROP2 Antibodies In Clinical Trials: > 45 Drugs
- TROP2 Antibodies Clinical Trials Insight By Company, Country, Indication & Phase
- Combination Approaches for TROP2 Antibody
Datopotamab deruxtecan, another promising investigational TROP2-targeting drug developed by Daiichi Sankyo and AstraZeneca, has shown positive results in trials for various solid cancers. In the first half of 2024, both the FDA and EMA accepted applications for its Biologics License Application (BLA) and Marketing Authorization Application (MAA) for treating non-squamous non-small cell lung cancer and HR-positive, HER2-negative breast cancer. This progress highlights the growing interest in TROP2 as a therapeutic target and suggests the potential for more approved treatments soon.
The landscape of TROP2-targeted therapies is primarily characterized by antibody-drug conjugates (ADCs), which effectively merge the specificity of monoclonal antibodies with potent cytotoxic agents. This strategy facilitates the precise delivery of chemotherapy directly to cancer cells, thereby reducing systemic side effects. Although ADCs lead the way in TROP2-targeted therapies, other innovative methods are also under investigation. These include RNA-based therapies and cell therapies, which focus on altering TROP2 expression or leveraging the immune system to attack cancer cells that express TROP2.
The competitive environment surrounding TROP2 therapies is rapidly evolving, with a multitude of clinical trials currently in progress. Prominent pharmaceutical and biotechnology companies, such as Merck, Hansoh BioMedical, BiOneCure Therapeutics, Bio-Thera Solutions, Biohaven Therapeutics, and Shanghai Fudan-Zhangjiang Bio-Pharmaceutical, are making significant investments in this area. This heightened competition is fostering innovation and may expedite the introduction of new treatment alternatives for patients.
Notably, China is leading the TROP2 therapeutic landscape, showcasing a significant number of clinical trials and participating companies, with the US closely trailing behind. This development underscores the increasing significance of the Chinese biopharmaceutical sector and its commitment to pioneering cancer treatments. The international scope of TROP2 research and development indicates that patients around the globe may soon have access to these innovative therapies.
As the field progresses, several key factors will be crucial for advancing TROP2-targeted therapies. Extensive long-term data on the efficacy and safety of both approved and experimental treatments will be essential for integrating these therapies into standard protocols and achieving broader acceptance. Identifying biomarkers for patient stratification will be critical to enhance treatment outcomes and ensure therapies are administered to those most likely to benefit. Additionally, understanding resistance mechanisms to TROP2-targeted therapies will be vital for developing strategies to mitigate or prevent resistance, potentially through combination therapies or next-generation agents.
The rapid development of therapies targeting TROP2 marks a notable progression in the field of precision oncology. As additional data is gathered from ongoing clinical trials and the practical application of approved treatments, the comprehensive potential of TROP2 targeting in cancer management will become more evident. The achievements observed to date indicate that TROP2-targeted therapies could assume a more prominent position in the treatment of diverse epithelial cancers, thereby enhancing outcomes for patients who have few treatment alternatives.
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Companies Mentioned (Partial List)
A selection of companies mentioned in this report includes, but is not limited to:
- Abion Bio
- Amunix
- Aptamer Sciences
- Arbele
- Aston Science
- AstraZeneca
- Beijing Biocytogen
- BiOneCure Therapeutics
- Biosion
- Bio-Thera Solutions
- Daiichi Sankyo Company
- Hangzhou DAC Biotech
- Innovent Biologics
- Janux Therapeutics
- LegoChem Biosciences
- Merck
- Molecular Templates
- OBI Pharma
- Peak Bio
- Radiopharm Theranostics
- Shanghai Henlius Biotech
- Suzhou GeneQuantum Healthcare