PUBLISHER: DelveInsight | PRODUCT CODE: 1576911
PUBLISHER: DelveInsight | PRODUCT CODE: 1576911
Recent advancements in HER2 treatments have enhanced HER2-positive breast cancer management, yet relapse remains a primary challenge due to disease heterogeneity and drug resistance mechanisms.
The approval of HERCEPTIN marked a turning point in HER2-positive breast cancer treatment. HERCEPTIN was the first targeted treatment for a solid tumor and the first drug to be paired with a companion diagnostic.
Despite the effectiveness of trastuzumab in combination with chemotherapy, a substantial portion (30-50%) of treatment-naive HER2-positive metastatic breast cancer patients do not respond well initially, indicating resistance to trastuzumab. This underscores its limitations and the need for ongoing research to tackle resistance issues with novel therapies.
PERJETA is often used alongside trastuzumab and chemotherapy; pertuzumab's approval marked a significant milestone. The combination of trastuzumab and pertuzumab has become a standard of care for neoadjuvant and metastatic front-line settings.
The development of ADCs represents a breakthrough in treating metastatic breast cancer, particularly in HER2-positive breast cancer. Among these, KADCYLA was the first to gain FDA approval for breast cancer treatment.
Anti-HER2 therapies, such as HERCEPTIN, PERJETA, KADCYLA, ENHERTU, and others, have changed the treatment paradigm of HER2-positive cancers, which were previously associated with more aggressive disease and poorer outcomes.
Seagen's comprehensive TUKYSA development plan includes a Phase II trial (HER2CLIMB-04) combining TUKYSA with ENHERTU for second-line HER2-positive breast cancer and a Phase III trial (HER2CLIMB-05) evaluating TUKYSA with HERCEPTIN and Roche's PERJETA as a first-line maintenance regimen.
Both TUKYSA and KADCYLA are HER2-targeted agents, and both are under pressure from AstraZeneca and Daiichi Sankyo's ADC ENHERTU, which has handily beaten KADCYLA in a head-to-head trial.
Companies like Byondis, Hoffmann-La Roche, Ambrx, and Zymeworks/Jazz Pharmaceuticals actively engage in mid and late-stage research and development efforts for HER2-positive breast cancer. The pipeline of HER2-positive breast cancer possesses few potential drugs.
ARX788 may potentially become the ADC of choice for post-ENHERTU patients with its unique ADC structure.
As promising novel anti-HER2 treatments emerge, the field will continue to revolutionize, with guidelines beginning to include novel treatment options in the third-line setting and thereafter.
In 2023, the United States accounted for the maximum share of the total market of HER2-positive breast cancer in the 7MM was around 60%.
DelveInsight's "Metastatic HER2-positive Breast Cancer Market Insights, Epidemiology, and Market Forecast - 2034" report delivers an in-depth understanding of the HER2-positive breast cancer, historical and forecasted epidemiology as well as the HER2-positive breast cancer market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.
The Metastatic HER2-positive breast cancer market report provides current treatment practices, emerging drugs, HER2-positive breast cancer market share of the individual therapies, and current and forecasted HER2-positive breast cancer market size from 2020 to 2034, segmented by seven major markets. The report also covers current HER2-positive breast cancer treatment practices/algorithms and unmet medical needs to curate the best of the opportunities and assess the underlying potential of the market.
Breast cancer initiates when abnormal cancerous cells in the breast grow and proliferate, creating a tumor. It usually starts in the ducts or lobules of the breast.
Some breast cancers depend on the human epidermal growth factor receptor 2 (HER2) gene to grow. These cancers are called HER2+ and have many copies of the HER2 gene or high levels of the HER2 protein. These proteins are also called "receptors." The HER2 gene makes the HER2 protein found in cancer cells and is important for tumor cell growth. Human epidermal growth factor receptor-2 positive (HER2+) is breast cancer that tests positive for the HER2 protein. HER2+ breast cancer grows faster and is more likely to spread and return than human epidermal growth factor receptor-2 negative (HER2-) breast cancer. Patients' HER2 status is determined by whether breast cancer tests are positive or negative for the HER2 protein.
Various tests such as tumor mutation testing: MSI-H/dMMR mutation, PD-1, and PD-L1 testing, FISH (Fluorescence in Situ Hybridization), Immunohistochemistry (IHC), Next-generation sequencing, Polymerase chain reaction, and genetic risk testing: BRCA tests are employed to determine the presence of HER2-positive breast cancer. The appearance of results in the report will vary based on the specific test conducted. Two widely used tests are the IHC test (Immunohistochemistry) and the FISH test (Fluorescence in Situ Hybridization).
It is important to know which HER2 test the patient had. Generally, only cancers that test IHC 3+ or FISH positive respond to the medicines that target HER2-positive breast cancers. An IHC 2+ test result is called borderline. If the patient has an IHC 2+ result, ask to retest the tissue with the FISH test.
Metastatic breast cancer is primarily treated with targeted therapy and hormonal therapy. First-line treatment choice depends on receptor status, including estrogen, progesterone, and HER2 receptors. In cases where both HER2 and estrogen receptors are positive, initial treatment may involve hormonal therapy, HER2-targeted therapy, or a combination of both.
Anti-HER2 therapies (also called HER2 inhibitors or HER2-targeted therapies) are a class of medicines used to treat all stages of HER2-positive breast cancer, from early-stage to metastatic. HERCEPTIN (trastuzumab) treats early-stage and advanced HER2-positive breast cancer and can be given with chemotherapy and sometimes another targeted therapy called PERJETA (pertuzumab). Antibody-drug conjugates such as ENHERTU, KADCYLA, and PHESGO can treat unresectable or metastatic HER2-positive breast cancer. Another therapy, NERLYNX, combines chemotherapy to treat advanced-stage and metastatic HER2-positive breast cancer. Apart from this, TUKYSA (tucatinib) treats metastatic or locally advanced HER2-positive breast cancer that cannot be completely removed with surgery after the cancer has been treated with at least one anti-HER2 medicine.
Using a Single-signal (HER2 gene) Assay (single-probe ISH)
Specimen Using A Dual-signal (HER2 gene) Assay (dual-probe ISH)