Natera Announces Enrollment of First Patients in SAGITTARIUS: a Randomized, Phase III Clinical Trial in Colon Cancer
Natera has announced the enrollment of the first patients in the SAGITTARIUS clinical trial, a phase III study aimed at using Signatera to guide personalized adjuvant treatment strategies for colon cancer. Sponsored by the AIRC Institute of Molecular Oncology and funded by the European Union Horizon Europe Programme, the study plans to enroll 700-900 patients across more than 20 sites. The trial will compare genotype-guided therapy versus standard chemotherapy for Signatera-positive patients and explore the use of immunotherapy and targeted agents earlier in the disease course. For Signatera-negative patients, the trial will assess treatments chosen by physicians, with options for observation or single-agent capecitabine. SAGITTARIUS involves collaborations with 9 partners in 5 European countries and a network of 26 clinical centers in Italy, Spain, and Germany. The trial aims to personalize treatment approaches and potentially reduce chemotherapy for certain patients.
Natera ha annunciato l'arruolamento dei primi pazienti nello studio clinico SAGITTARIUS, uno studio di fase III volto a utilizzare Signatera per guidare strategie di trattamento adiuvante personalizzate per il cancro al colon. Sponsorizzato dall'Istituto AIRC di Oncologia Molecolare e finanziato dal Programma Horizon Europe dell'Unione Europea, lo studio prevede di arruolare 700-900 pazienti in oltre 20 centri. La sperimentazione confronterà la terapia guidata dal genotipo con la chemioterapia standard per i pazienti positivi a Signatera e esplorerà l'uso dell'immunoterapia e di agenti mirati in fase precoce della malattia. Per i pazienti negativi a Signatera, lo studio valuterà i trattamenti scelti dai medici, con opzioni per osservazione o capecitabina in monoterapia. SAGITTARIUS coinvolge collaborazioni con 9 partner in 5 paesi europei e una rete di 26 centri clinici in Italia, Spagna e Germania. L'obiettivo della sperimentazione è quella di personalizzare gli approcci terapeutici e potenzialmente ridurre la chemioterapia per alcuni pazienti.
Natera ha anunciado la inclusión de los primeros pacientes en el ensayo clínico SAGITTARIUS, un estudio de fase III destinado a utilizar Signatera para guiar estrategias de tratamiento adyuvante personalizadas para el cáncer de colon. Patrocinado por el Instituto AIRC de Oncología Molecular y financiado por el Programa Horizon Europe de la Unión Europea, el estudio planea incluir entre 700 y 900 pacientes en más de 20 sitios. El ensayo comparará la terapia guiada por genotipos contra la quimioterapia estándar para pacientes positivos a Signatera y explorará el uso de inmunoterapia y agentes dirigidos en etapas tempranas de la enfermedad. Para los pacientes negativos a Signatera, el ensayo evaluará tratamientos seleccionados por los médicos, con opciones de observación o capecitabina en monoterapia. SAGITTARIUS implica colaboraciones con 9 socios en 5 países europeos y una red de 26 centros clínicos en Italia, España y Alemania. El objetivo del ensayo es personalizar los enfoques de tratamiento y reducir potencialmente la quimioterapia para ciertos pacientes.
Natera는 SAGITTARIUS 임상 시험에 첫 환자 등록을 발표했습니다. 이 3상 연구는 Signatera를 사용하여 대장암에 대한 맞춤형 보조 치료 전략을 안내하는 것을 목표로 합니다. AIRC 분자 종양학 연구소가 후원하고 유럽 연합 Horizon Europe 프로그램이 자금을 지원하는 이 연구는 20개 이상의 사이트에서 700-900명의 환자를 등록할 계획입니다. 이 시험은 Signatera 양성 환자에 대해 유전자형 기반 치료와 표준 화학 요법을 비교하고 질병의 초기 단계에서 면역 요법 및 표적 치료제의 사용을 탐구합니다. Signatera 음성 환자의 경우, 시험은 의사가 선택한 치료를 평가하며, 관찰이나 단일 약제인 카페시타빈 옵션이 있습니다. SAGITTARIUS는 5개 유럽 국가에서 9개의 파트너와의 협력을 포함하며 이탈리아, 스페인, 독일에 있는 26개의 임상 센터 네트워크를 형성합니다. 이 시험은 치료 접근 방식을 개인화하고 일부 환자에 대해 화학 요법을 잠재적으로 줄이는 것을 목표로 합니다.
Natera a annoncé l'inclusion des premiers patients dans l'essai clinique SAGITTARIUS, une étude de phase III visant à utiliser Signatera pour guider des stratégies de traitement adjuvant personnalisées pour le cancer du colon. Sponsorisé par l'Institut AIRC d'Oncologie Moléculaire et financé par le programme Horizon Europe de l'Union Européenne, l'étude prévoit d'inscrire 700 à 900 patients dans plus de 20 sites. L'essai comparera la thérapie guidée par génotype à la chimiothérapie standard pour les patients positifs au Signatera et explorera l'utilisation de l'immunothérapie et des agents ciblés plus tôt dans l'évolution de la maladie. Pour les patients négatifs au Signatera, l'essai évaluera les traitements choisis par les médecins, avec des options d'observation ou de capécitabine en monothérapie. SAGITTARIUS implique des collaborations avec 9 partenaires dans 5 pays européens et un réseau de 26 centres cliniques en Italie, en Espagne et en Allemagne. L'objectif de l'essai est de personnaliser les approches thérapeutiques et potentiellement de réduire la chimiothérapie pour certains patients.
Natera hat die Einschreibung der ersten Patienten in die klinische Studie SAGITTARIUS angekündigt, eine Phase-III-Studie, die darauf abzielt, Signatera zur Anleitung personalisierter adjuvanter Behandlungsstrategien bei Kolorektalkrebs zu verwenden. Die Studie wird vom AIRC-Institut für Molekulare Onkologie gesponsert und wird durch das Horizont Europa-Programm der Europäischen Union finanziert. Es ist geplant, 700-900 Patienten an mehr als 20 Standorten zu rekrutieren. Die Studie wird die genotyp-gesteuerte Therapie mit der Standard-Chemotherapie für Signatera-positive Patienten vergleichen und den Einsatz von Immuntherapie und zielgerichteten Mitteln in einem früheren Stadium der Erkrankung untersuchen. Für Signatera-negative Patienten wird die Studie Behandlungen bewerten, die von Ärzten ausgewählt wurden, einschließlich Optionsmöglichkeiten für Beobachtung oder Einzelagent Capecitabin. SAGITTARIUS umfasst Kooperationen mit 9 Partnern in 5 europäischen Ländern und ein Netzwerk von 26 klinischen Zentren in Italien, Spanien und Deutschland. Ziel der Studie ist es, die Behandlungsansätze zu personalisieren und möglicherweise die Chemotherapie für bestimmte Patienten zu reduzieren.
- Enrollment of first patients in a significant phase III clinical trial.
- Potential to personalize adjuvant treatment strategies for colon cancer patients.
- Collaboration with 9 partners and 26 clinical centers across Europe.
- Exploration of immunotherapy and targeted therapies earlier in disease course.
- The trial is still in the early stages with results yet to be determined.
Insights
The launch of SAGITTARIUS marks a pivotal shift in colorectal cancer treatment paradigms. This phase III trial with 700-900 patients represents a significant advancement in precision oncology, potentially revolutionizing the standard of care for stage II and III colon cancer patients. The trial's design is particularly sophisticated, using Signatera's MRD testing to stratify patients and personalize treatment decisions - a first of its kind approach in early-stage colon cancer.
The study's dual-arm design is noteworthy: Signatera-positive patients receive targeted therapy based on their tumor's genetic profile, while Signatera-negative patients may avoid unnecessary chemotherapy. This could lead to better outcomes while reducing overtreatment. The multi-country collaboration across 26 clinical centers adds robust credibility to the trial's potential findings.
This trial positions Natera strategically in the precision oncology market. The SAGITTARIUS study could significantly expand Signatera's clinical utility and market penetration in colorectal cancer - a major oncology segment. If successful, this could drive substantial revenue growth through increased test adoption and potential inclusion in treatment guidelines.
The EU Horizon Europe Programme funding and collaboration with prestigious European institutions validates Natera's technology and reduces R&D costs. A positive outcome could establish Signatera as the standard for treatment selection in early-stage colon cancer, creating a significant competitive advantage. The company's
SAGITTARIUS is Natera's first interventional trial using SignateraTM to select patients for targeted therapy in early-stage colon cancer
Approximately 700-900 patients expected to be enrolled across more than 20 sites
The study aims to enroll approximately 700-900 stage III and high-risk stage II colon cancer patients following surgical resection.
- Signatera-positive patients will be randomized to receive either genotype-guided therapy tailored to their individual tumor mutational profile or six months of standard chemotherapy. The trial’s investigational arm will explore the potential of administering immunotherapy or targeted agents approved for metastatic colon cancer earlier in the disease course to increase the proportion of patients cured with adjuvant therapy. This genomically-driven approach will focus on mismatch repair status, POLE, RAS/RAF mutation status, and HER2 amplification status.
- For Signatera-negative patients, the trial will compare physician choice treatments with options for de-escalation to observation or single-agent capecitabine for six months.
SAGITTARIUS includes collaborations with 9 partners in 5 countries in
“The enrollment of the first patients in SAGITTARIUS represents a significant milestone in a trial that has the potential to transform treatment approaches for colorectal cancer,” said Silvia Marsoni, MD, PhD, head of the precision oncology unit at IFOM ETS and scientific coordinator of the SAGITTARIUS Project.
“The trial aims to move beyond the traditional one-size-fits-all, post-surgical standard of care with chemotherapy by introducing a truly personalized treatment approach tailored to each patient,” said Adham Jurdi, MD, senior medical director of oncology at Natera. “Signatera-positive patients will receive adjuvant therapies matched to their specific mutational profiles. Additionally, we are optimistic that the study will generate evidence to support the de-escalation of chemotherapy for Signatera-negative patients.”
Clara Montagut, MD, PhD, head of the gastrointestinal cancer unit at Hospital del Mar in
About the SAGITTARIUS Horizon Europe project
The SAGITTARIUS clinical trial is part of a wider effort, the SAGITTARIUS project, funded by the European Union Horizon Europe Programme. The SAGITTARIUS project, which also includes health cost and quality of life research to comprehensively assess the full cost-effectiveness of interventional liquid biopsy, aims to pave the way for more effective, tailored treatments that enhance both outcomes and quality of life for colon cancer patients, while potentially lowering the cost impact on private and public health systems and reducing treatment disparities. The SAGITTARIUS project is a collaboration of 9 partners in
About IFOM ETS
IFOM ETS - the AIRC Institute of Molecular Oncology is a leading cancer research institute based in
About Signatera
Signatera is a personalized, tumor-informed, molecular residual disease test for patients previously diagnosed with cancer. Custom-built for each individual, Signatera uses circulating tumor DNA to detect and quantify cancer left in the body, identify recurrence earlier than standard-of-care tools, and help optimize treatment decisions. The test is available for clinical and research use and is covered by Medicare for patients with colorectal cancer, breast cancer, ovarian cancer, and muscle-invasive bladder cancer, as well as for immunotherapy monitoring of any solid tumor. Signatera has been clinically validated across multiple cancer types and indications, with published evidence in over 100 peer-reviewed papers.
About Natera
Natera™ is a global leader in cell-free DNA and genetic testing, dedicated to oncology, women’s health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard of care to protect health and inform earlier, more targeted interventions that help lead to longer, healthier lives. Natera’s tests are validated by more than 250 peer-reviewed publications that demonstrate high accuracy. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in
Forward-Looking Statements
All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera’s plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera’s expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to whether the results of clinical or other studies will support the use of our product offerings, the impact of results of such studies, our expectations of the reliability, accuracy, and performance of our tests, or of the benefits of our tests and product offerings to patients, providers, and payers. Additional risks and uncertainties are discussed in greater detail in "Risk Factors" in Natera’s recent filings on Forms 10-K and 10-Q, and in other filings Natera makes with the SEC from time to time. These documents are available at www.natera.com/investors and www.sec.gov.
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Investor Relations: Mike Brophy, CFO, Natera, Inc., 510-826-2350, investor@natera.com
Media: Lesley Bogdanow, VP of Corporate Communications, Natera, Inc., pr@natera.com
Source: Natera, Inc.
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