HER2-positive breast cancer is a subtype of breast cancer, driven by overexpression of the human epidermal growth factor receptor 2 (HER2). According to Elisa Agostinetto et al., 2024, it accounts for approximately 15% of all breast cancer diagnoses. The growing focus on precision oncology, novel antibody-drug conjugates, and combination therapies is driving innovation in this field. According to the HER2 positive breast cancer pipeline analysis by Expert Market Research, the market is expected to witness significant growth in the coming years, supported by ongoing clinical trials and regulatory approvals of next-generation treatments.
Major companies involved in the HER2 positive breast cancer pipeline analysis include Chia Tai Tianqing Pharmaceutical Group Co., Ltd., CSPC ZhongQi Pharmaceutical Technology Co., Ltd., and others.
Leading drugs currently in the pipeline include TQB2102, ARX788, XMT-2056, and others.
The HER2-positive breast cancer drug pipeline is expanding due to rising clinical trial activity, increased focus on antibody-drug conjugates (ADCs), and growing investments in targeted and combination therapies.
The HER2 Positive Breast Cancer Pipeline Analysis Report by Expert Market Research gives comprehensive insights into HER2 positive breast cancer therapeutics currently undergoing clinical trials. It covers various aspects related to the details of each of these drugs under development for HER2 positive breast cancer. The HER2 positive breast cancer report assessment includes the analysis of over 100 pipeline drugs and 50+ companies. The HER2 positive breast cancer pipeline landscape will include an analysis based on efficacy and safety measure outcomes published for the trials, including their adverse effects on patients suffering from the condition, and alignment with HER2 positive breast cancer treatment guidelines to ensure optimal care practices.
The assessment part will include a detailed analysis of each drug, drug class, clinical studies, phase type, drug type, route of administration, and ongoing product development activities related to HER2 positive breast cancer.
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HER2-positive breast cancer is an aggressive form of breast cancer where cancer cells have higher-than-normal levels of the human epidermal growth factor receptor 2 (HER2) protein. This overexpression promotes rapid cell growth and division. It occurs due to gene amplification or overproduction of the HER2 protein on cancer cell surfaces.
HER2-positive breast cancer is treated with targeted therapies, chemotherapy, hormone therapy, and surgery. Targeted drugs block HER2 receptors to slow or stop tumor growth and reduce recurrence. In May 2022, the U.S. Food and Drug Administration granted full approval to fam-trastuzumab deruxtecan-nxki (Enhertu) for treating adult patients with unresectable or metastatic HER2-positive breast cancer, following results from the DESTINY-Breast03 trial showing significantly improved progression-free survival.
According to Elisa Agostinetto et al., human epidermal growth factor receptor 2 (HER2)-positive breast cancer accounts for approximately 15% of all breast cancer cases. As per the World Health Organization (WHO), breast cancer caused 670,000 global deaths in 2022 and was the most common cancer among women in 157 of 185 countries. The American Cancer Society estimates 316,950 new invasive breast cancer cases in U.S. women by 2025. According to Breast Cancer Now, breast cancer is the most common cancer in the United Kingdom, comprising 15% of all new cases, with a woman diagnosed every 10 minutes. As per Krishnan Sathishkumar et al., 2024, breast cancer accounts for 28.2% of female cancers in India. These rising numbers highlight the urgent need for innovative HER2-targeted therapies.
This section of the report covers the analysis of HER2 positive breast cancer drug candidates based on several segmentations, including:
By Phase
By Drug Class
By Route of Administration
The report covers phase I, phase II, phase III, phase IV, and early-phase drugs. The coverage includes an in-depth analysis of each drug across these phases. According to EMR analysis, phase II covers a major share of the total HER2 positive breast cancer clinical trials with 50%, followed by phase III at 26%, and phase I at 20%. This strong pipeline distribution highlights active research across all stages, fostering innovation and promising advancements in targeted therapies for HER2 positive breast cancer.
The drug molecule categories covered under the HER2 positive breast cancer pipeline analysis include small molecules, monoclonal antibodies, gene therapies, peptides, and polymers. The HER2 positive breast cancer report provides a comparative analysis of the drug classes for each drug in various phases of clinical trials for HER2-positive breast cancer. Antibody-drug conjugates are emerging as a promising drug class in the HER2-positive breast cancer pipeline. For instance, SHR-A1811, a third-generation antibody-drug conjugate composed of trastuzumab, a cleavable linker, and a topoisomerase I inhibitor, has shown encouraging efficacy. It achieved a 79.1% objective response rate and a median progression-free survival of 20 months in pretreated patients.
The EMR report for the HER2 positive breast cancer pipeline covers the profile of key companies involved in clinical trials and their drugs under development. It provides a detailed HER2 positive breast cancer therapeutic assessment, analyzing the competitive dynamics of the clinical trial landscape. Below is the list of a few players involved in HER2 positive breast cancer clinical trials:
This section covers the detailed analysis of each drug under multiple phases, including phase I, phase II, phase III, phase IV, and emerging drugs for HER2 positive breast cancer. It includes product description, trial ID, study type, drug class, mode of administration, and recruitment status of HER2 positive breast cancer drug candidates.
TQB2102, sponsored by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd., is an anti-HER2 antibody-drug conjugate under evaluation in a Phase III clinical trial. This study is assessing its safety and efficacy compared to TCbHP in neoadjuvant treatment for HER2-positive breast cancer. TQB2102 targets two HER2 epitopes (ECD2 and ECD4) and combines a bispecific antibody with a topoisomerase I inhibitor through a cleavable linker.
ARX788 is currently undergoing a global Phase 2 clinical trial, sponsored by Ambrx, Inc., for patients with HER2-positive metastatic breast cancer previously treated with T-DXd. The objective of this phase is to evaluate the efficacy and safety of ARX788 administered via IV every 3 weeks. ARX788 is a novel antibody-drug conjugate (ADC) combining a HER2-targeted monoclonal antibody with a cytotoxic payload, AS269, using site-specific conjugation technology for enhanced precision and potency.
XMT-2056 is currently undergoing a Phase 1 clinical trial sponsored by Mersana Therapeutics to evaluate its safety, tolerability, and recommended dose in patients with advanced or recurrent HER2-expressing solid tumors. This novel immunosynthen ADC targets a unique epitope on HER2, enabling immune-mediated killing of adjacent HER2-negative cells. The study is examining its monotherapy potential and exploring synergy with anti–PD-1 and HER2-targeted agents like trastuzumab.
*Please note that this is only a partial list; the complete list of drugs will be available in the full report.*
The HER2 Positive Breast Cancer Pipeline Analysis Report provides a strategic overview of the latest and future landscape of treatments for HER2 positive breast cancer. It provides necessary information for making informed investment decisions along with research, development, and strategic planning efforts. The stakeholders will benefit from the essential insights into HER2 positive breast cancer collaborations, regulatory environments, and potential growth opportunities.
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*While we strive to always give you current and accurate information, the numbers depicted on the website are indicative and may differ from the actual numbers in the main report. At Expert Market Research, we aim to bring you the latest insights and trends in the market. Using our analyses and forecasts, stakeholders can understand the market dynamics, navigate challenges, and capitalize on opportunities to make data-driven strategic decisions.*
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