BioNTech and Duality Score Initial Trial Success with Breast Cancer Precision Drug

BioNTech and Duality have scored an initial trial win with their breast cancer precision drug. Roche Holding AG's Pharmaceuticals Division consists of two business segments: Roche Pharmaceuticals and Chugai. The Diagnostics Division includes four business areas: Diabetes Care, Molecular Diagnostics, Professional Diagnostics, and Tissue Diagnostics. The company develops medicines for various disease areas, including oncology, immunology, and neuroscience.

Roche Holding AG has received CE IVDR approval for its VENTANA® HER2 (4B5) Rabbit Monoclonal Primary Antibody RxDx assay, expanding its capabilities to identify patients with HER2-ultralow breast cancer and HER2-positive biliary tract cancer. This approval is a significant milestone in Roche's ongoing efforts to enhance personalized treatment options for cancer patients.

The VENTANA HER2 (4B5) test is now CE-IVDR approved to aid in the assessment of HER2-ultralow status to identify metastatic breast cancer patients who may be eligible for treatment with ENHERTU® (trastuzumab deruxtecan). Additionally, the test is approved to help identify patients with previously-treated, unresectable or metastatic HER2-positive biliary tract cancer (BTC) who may be eligible for treatment with ZIIHERA® (zanidatamab-hrii).

The approval of the VENTANA HER2 (4B5) test marks a significant advancement in the understanding and treatment of HER2-positive cancers. The test enables the identification of a new patient population designated as "HER2-ultralow," referring to patients who have very low levels of HER2 expression. Approximately 20-25 percent of hormone receptor (HR)-positive, HER2-negative breast cancer patients may be considered HER2-ultralow, making them eligible for ENHERTU.

In Europe, more than 564,000 people will be diagnosed with breast cancer this year, with more than 145,000 estimated deaths. Metastatic breast cancer incidence is rising in younger populations and is the leading cause of breast cancer-related deaths [1]. The VENTANA HER2 (4B5) test was used in the DESTINY-Breast06 trial, which demonstrated a significant improvement in progression-free survival with ENHERTU compared to standard of care chemotherapy in patients with HER2-low and HER2-ultralow metastatic breast cancer [2].

The approval of the VENTANA HER2 (4B5) test for biliary tract cancer (BTC) patients is also a notable achievement. BTC is often diagnosed at an advanced stage, and patients currently have very few treatment options. The VENTANA HER2 (4B5) test is now approved to identify BTC patients with HER2-positive status who may be eligible for treatment with ZIIHERA.

The VENTANA HER2 (4B5) Rabbit Monoclonal Primary Antibody RxDx assay delivers timely, clear, and reliable results, driving diagnostic certainty and enabling therapeutic decisions that can lead to better outcomes for patients. The test is used in combination with the fully automated VENTANA BenchMark slide staining instrument, standardizing all immunohistochemistry (IHC) processes and reducing the possibility of human error.

Roche continues to be a leader in breast cancer diagnostics, helping to expand patient access to personalized treatment. The company's Diagnostics Division includes four business areas: Diabetes Care, Molecular Diagnostics, Professional Diagnostics, and Tissue Diagnostics. Roche develops medicines for various disease areas, including oncology, immunology, and neuroscience.

References:
[1] International agency for research on cancer. [Internet, cited 2025 August 25]
[2] Shami, R. et al. Analytical and clinical validation of PATHWAY HER2 (4B5) Assay for assessment of HER2-low/HER2-ultralow status and eligibility for trastuzumab deruxtecan in DESTINY-Breast06; Supplementary Materials. ESMO Open, Volume 10, Issue 6, 105310.