Roche receives FDA approval for the first companion diagnostic to identify patients with HER2-ultralow metastatic breast cancer eligible for ENHERTU
Roche has received FDA approval for an expanded use of its PATHWAY HER2 (4B5) test, making it the first companion diagnostic to identify patients with HER2-ultralow metastatic breast cancer eligible for ENHERTU treatment. This advancement is particularly significant as approximately 20-25% of hormone receptor-positive, HER2-negative breast cancer patients may be classified as HER2-ultralow.
The DESTINY-Breast06 trial demonstrated promising results, showing a median progression-free survival of 13.2 months with ENHERTU compared to 8.1 months with standard chemotherapy. This test expansion builds upon Roche's 2022 approval for HER2-low status assessment, further strengthening their position in HER2 diagnostics and expanding treatment options for breast cancer patients.
Roche ha ricevuto l'approvazione della FDA per un uso ampliato del suo test PATHWAY HER2 (4B5), diventando il primo test diagnostico companion in grado di identificare i pazienti con cancro mammario metastatico HER2-ultralow idonei per il trattamento con ENHERTU. Questo progresso è particolarmente significativo poiché circa il 20-25% dei pazienti con carcinoma mammario positivo ai recettori ormonali e negativo per HER2 possono essere classificati come HER2-ultralow.
Lo studio DESTINY-Breast06 ha mostrato risultati promettenti, evidenziando una durata mediana di sopravvivenza libera da progressione di 13,2 mesi con ENHERTU rispetto a 8,1 mesi con la chemioterapia standard. Questa espansione del test si basa sull'approvazione ottenuta da Roche nel 2022 per la valutazione dello stato HER2-low, rafforzando ulteriormente la loro posizione nella diagnostica HER2 e ampliando le opzioni di trattamento per i pazienti affetti da cancro al seno.
Roche ha recibido la aprobación de la FDA para un uso ampliado de su prueba PATHWAY HER2 (4B5), convirtiéndose en el primer diagnóstico compañero en identificar a pacientes con cáncer de mama metastásico HER2-ultralow elegibles para el tratamiento con ENHERTU. Este avance es particularmente significativo, ya que aproximadamente el 20-25% de los pacientes con cáncer de mama positivo para receptores hormonales y HER2-negativo pueden clasificarse como HER2-ultralow.
El ensayo DESTINY-Breast06 demostró resultados prometedores, mostrando una mediana de supervivencia libre de progresión de 13,2 meses con ENHERTU en comparación con 8,1 meses con quimioterapia estándar. Esta expansión de la prueba se basa en la aprobación de Roche en 2022 para la evaluación del estado HER2-low, reforzando aún más su posición en los diagnósticos HER2 y ampliando las opciones de tratamiento para los pacientes con cáncer de mama.
로슈는 PATHWAY HER2 (4B5) 테스트의 사용 확대에 대한 FDA 승인을 받아 HER2-초저농도 전이성 유방암 환자를 식별할 수 있는 최초의 동반 진단 테스트가 되었습니다. 이 발전은 호르몬 수용체 양성이고 HER2 음성인 유방암 환자의 약 20-25%가 HER2-초저농도로 분류될 수 있다는 점에서 특히 중요합니다.
DESTINY-Breast06 시험은 ENHERTU를 사용했을 때 중위 무병 생존 기간이 13.2개월에 달하며, 표준 화학요법에서의 8.1개월과 비교되는 유망한 결과를 보여주었습니다. 이 검사 확대는 2022년 HER2-low 상태 평가를 위한 로슈의 승인에 기반하고 있으며, HER2 진단에서의 입지를 더욱 강화하고 유방암 환자를 위한 치료 옵션을 확대하고 있습니다.
Roche a reçu l'approbation de la FDA pour une utilisation élargie de son test PATHWAY HER2 (4B5), devenant ainsi le premier test de diagnostic compagnon capable d'identifier les patients atteints de cancer du sein métastatique HER2-ultralow éligibles pour le traitement par ENHERTU. Cette avancée est particulièrement significative puisque près de 20 à 25 % des patients atteints de cancer du sein positif aux récepteurs hormonaux et négatif pour HER2 peuvent être classés comme HER2-ultralow.
L'essai DESTINY-Breast06 a montré des résultats prometteurs, mettant en évidence une durée médiane de survie sans progression de 13,2 mois avec ENHERTU, contre 8,1 mois avec la chimiothérapie standard. Cette expansion du test repose sur l'approbation de Roche en 2022 pour l'évaluation du statut HER2-low, renforçant encore leur position dans le diagnostic HER2 et élargissant les options de traitement pour les patients atteints de cancer du sein.
Roche hat von der FDA die Genehmigung für eine erweiterte Verwendung des PATHWAY HER2 (4B5) Tests erhalten, wodurch er der erste begleitende Diagnosetest ist, der Patienten mit HER2-ultralow metastasierendem Brustkrebs identifiziert, die für die ENHERTU-Behandlung geeignet sind. Dieser Fortschritt ist besonders bedeutend, da etwa 20-25% der hormonrezeptorpositiven, HER2-negativen Brustkrebspatienten als HER2-ultralow klassifiziert werden können.
Die STUDIE DESTINY-Breast06 zeigte vielversprechende Ergebnisse mit einer medianen progressionsfreien Überlebenszeit von 13,2 Monaten mit ENHERTU im Vergleich zu 8,1 Monaten mit der Standardchemotherapie. Diese Ausweitung des Tests baut auf der Genehmigung von Roche im Jahr 2022 zur Bewertung des HER2-low-Status auf und stärkt weiter ihre Position in der HER2-Diagnostik und erweitert die Behandlungsoptionen für Brustkrebspatienten.
- First FDA-approved companion diagnostic for HER2-ultralow breast cancer
- Targets a significant market segment (20-25% of HR-positive, HER2-negative breast cancer patients)
- Clinical trial shows 5.1 months improvement in progression-free survival vs standard treatment
- Expands market potential for existing PATHWAY HER2 test
- None.
- As seen in the DESTINY-Breast06 trial, approximately 20-25 percent of hormone receptor (HR)-positive, HER2-negative breast cancer patients may be considered HER2-ultralow.1 These patients may now be eligible for a targeted treatment, which could significantly improve their outcomes.
- The PATHWAY HER2 (4B5) test, the first and only FDA approved companion diagnostic for assessing HER2-low status since 2022, is now also approved to aid in the assessment of HER2-ultralow status for metastatic breast cancer patients.
- HER2 interpretation in breast cancer is evolving. With the introduction of HER2-low and now HER2-ultralow classifications, Roche continues to lead in HER2 diagnostics, helping to expand patient access to personalised treatment.
Basel, 31 January 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has approved a label expansion for the PATHWAY® anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody* to identify patients with HR-positive, HER2-ultralow metastatic breast cancer who may be eligible for treatment with ENHERTU®. ENHERTU is a specifically engineered HER2-directed antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialised by Daiichi Sankyo and AstraZeneca.
Until the introduction of HER2-low status in 2022, HER2 status was categorised as either “positive” or “negative” based on the level of HER2 expression. The PATHWAY HER2 (4B5) test has now received approval to identify a new patient population designated as "HER2-ultralow." HER2-ultralow refers to patients who have very low levels of HER2 expression, even lower than the existing HER2-low category.
“One in eight women in the United States will face invasive breast cancer in their lifetime,” said Matt Sause, CEO of Roche Diagnostics. “The rising incidence of metastatic breast cancer, particularly among younger populations, underscores the urgent need for new diagnostic options. The approval of our test for determining HER2-ultralow status offers new hope to patients by providing a possible path to HER2-targeted treatment where none existed before, helping clinicians transform outcomes for many facing this challenging disease.”
HER2 is a receptor protein that helps cancer cells grow quickly. To determine a patient’s HER2 status, pathologists evaluate, or score, the level of HER2 receptor protein expressed in breast cancer tissue samples. The PATHWAY HER2 (4B5) test was used as part of the DESTINY-Breast06 trial, which showed a median progression-free survival of 13.2 months with ENHERTU compared to 8.1 months with the standard of care (chemotherapy) in the overall trial population of patients with HER2-low and HER2-ultralow metastatic breast cancer. An exploratory analysis showed the results were consistent between patients with HER2-low and HER2-ultralow expression.2
The FDA approval of the new HER2-ultralow indication expands on the intended use for Roche’s on-market PATHWAY anti-HER2 (4B5) test, proven in delivering timely, clear, and confident results. The launch further strengthens and differentiates Roche’s comprehensive breast cancer solutions portfolio, aiding patients and providers in making informed decisions to improve outcomes.
About PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Antibody
Roche’s pre-diluted PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody, used in combination with the fully automated BenchMark IHC/ISH slide staining instrument, standardises all immunohistochemistry (IHC) processes from baking through staining and reduces the possibility of human error.3 It also minimises inherent variability resulting from individual reagent dilution and other processes found in manual and semi-automated IHC methods. The Roche HER2 (4B5) clone achieves consistently high proficiency assessment scores compared to other clones 4 and demonstrates high concordance with HER2 FISH,5,6 empowering laboratories to employ the most widely adopted and reliable HER2-IHC primary antibody.
About Roche
Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.
For over 125 years, sustainability has been an integral part of Roche’s business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045.
Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.
For more information, please visit www.roche.com.
* Hereafter referred to as PATHWAY HER2 (4B5) test
All trademarks used or mentioned in this release are protected by law.
References
[1] Salgado RF, et al. LBA21 - Human epidermal growth factor receptor 2 (HER2)-low and HER2-ultralow status determination in tumors of patients (pts) with hormone receptor–positive (HR+) metastatic breast cancer (mBC) in DESTINY-Breast06 (DB-06). Annals of Oncology. (2024) 35 (suppl_2): 1-72. 10.1016/annonc/annonc1623.
[2] Bardia A, et. al. Trastuzumab Deruxtecan after Endocrine Therapy in Metastatic Breast Cancer, New England Journal of Medicine. 2024; 391:2110-2122
[3] PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody Package Insert
[4] NORDIQC HER2 IHC Assessment Run B37 2024
[5] Mayr D, et al. Comprehensive immunohistochemical analysis of Her-2/neu oncoprotein overexpression in breast cancer: HercepTest™ (Dako) for manual testing and Her-2/neuTest 4B5 (VENTANA) for VENTANA BenchMark automatic staining system with correlation to results of BenchMark automatic staining system with correlation to results of fluorescence in situ hybridization (FISH). Virchows Archiv. 2009; 454(3):241–248.
[6] Brügmann A, Lelkaitis G, Nielsen S, et al. Testing HER2 in breast cancer: a comparative study on BRISH, FISH, and IHC. Appl Immunohistochem Mol Morphol. 2011;19(3):203-211.
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FAQ
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How does Roche's (RHHBY) PATHWAY HER2 test classify HER2 status in breast cancer patients?
