First of its Kind Colorectal Cancer Data from Prospective GALAXY Study Released at ESMO; Demonstrates Signatera';s Ability to Predict Overall Survival
Natera, Inc. (NASDAQ: NTRA) announced new data from the GALAXY arm of the CIRCULATE-Japan trial at the 2024 ESMO Congress. The study, involving 2,240 patients with stage II-IV colorectal cancer, demonstrated Signatera's ability to predict overall survival (OS) and adjuvant chemotherapy (ACT) benefit. Key findings include:
1. Signatera-positive patients showed 9.68 times higher risk of death compared to Signatera-negative patients.
2. Signatera-positive patients receiving ACT had a 50% reduction in death risk.
3. Signatera status was the most significant predictor of recurrence across all pathologic stages.
4. Sustained Signatera clearance after ACT was associated with 100% 24-month OS.
These results highlight Signatera's potential to improve outcomes for colorectal cancer patients through personalized treatment decisions.
Natera, Inc. (NASDAQ: NTRA) ha annunciato nuovi dati dall'braccio GALAXY dello studio CIRCULATE-Japan al Congresso ESMO 2024. Lo studio, che coinvolgeva 2.240 pazienti con cancro colorettale in stadio II-IV, ha dimostrato la capacità di Signatera di prevedere la sopravvivenza globale (OS) e il beneficio della chemioterapia adiuvante (ACT). I risultati chiave includono:
1. I pazienti positivi a Signatera mostrano un rischio di morte 9,68 volte più alto rispetto ai pazienti negativi a Signatera.
2. I pazienti positivi a Signatera che ricevono ACT hanno un riduzione del 50% del rischio di morte.
3. Lo stato di Signatera è stato il predittore più significativo di recidiva in tutti i stadi patologici.
4. Una clearance sostenuta di Signatera dopo ACT è stata associata a un OS del 100% a 24 mesi.
Questi risultati evidenziano il potenziale di Signatera di migliorare gli esiti per i pazienti affetti da cancro colorettale attraverso decisioni di trattamento personalizzate.
Natera, Inc. (NASDAQ: NTRA) anunció nuevos datos de la rama GALAXY del ensayo CIRCULATE-Japan en el Congreso ESMO 2024. El estudio, que involucró a 2.240 pacientes con cáncer colorrectal en estadio II-IV, demostró la capacidad de Signatera para predecir la supervivencia global (OS) y el beneficio de la quimioterapia adyuvante (ACT). Los hallazgos clave incluyen:
1. Los pacientes positivos a Signatera mostraron un riesgo de muerte 9,68 veces mayor en comparación con los pacientes negativos a Signatera.
2. Los pacientes positivos a Signatera que recibieron ACT tuvieron una reducción del 50% en el riesgo de muerte.
3. El estado de Signatera fue el predictor más significativo de recurrencia en todas las etapas patológicas.
4. La eliminación sostenida de Signatera después de ACT se asoció con un OS del 100% a 24 meses.
Estos resultados destacan el potencial de Signatera para mejorar los resultados en pacientes con cáncer colorrectal a través de decisiones de tratamiento personalizadas.
Natera, Inc. (NASDAQ: NTRA)는 2024 ESMO Congress에서 CIRCULATE-Japan 시험의 GALAXY 팔에서 새로운 데이터를 발표했습니다. 이번 연구는 2,240명의 환자를 대상으로 2기에서 4기 대장암을 연구했으며, Signatera가 전체 생존율 (OS)과 보조 화학 요법 (ACT)의 이점을 예측하는 능력을 입증했습니다. 주요 발견 사항은 다음과 같습니다:
1. Signatera 양성 환자는 Signatera 음성 환자에 비해 사망 위험이 9.68배 높음을 보여주었습니다.
2. ACT를 받은 Signatera 양성 환자는 사망 위험이 50% 감소했습니다.
3. Signatera 상태는 모든 병리학적 단계에서 재발의 가장 중요한 예측 인자였습니다.
4. ACT 후 Signatera 클리어런스가 유지되는 것은 24개월 OS 100%과 관련이 있었습니다.
이 결과는 개인화된 치료 결정을 통해 대장암 환자의 치료 결과를 향상시킬 수 있는 Signatera의 잠재력을 강조합니다.
Natera, Inc. (NASDAQ: NTRA) a annoncé de nouvelles données provenant du bras GALAXY de l'essai CIRCULATE-Japan lors du Congrès ESMO 2024. L'étude, impliquant 2.240 patients atteints de cancer colorectal au stade II-IV, a démontré la capacité de Signatera à prédire la survie globale (OS) et les bénéfices de la chimiothérapie adjuvante (ACT). Les résultats clés incluent :
1. Les patients positifs à Signatera présentaient un risque de mortalité 9,68 fois supérieur à celui des patients négatifs à Signatera.
2. Les patients positifs à Signatera recevant l'ACT avaient une réduction de 50% du risque de mortalité.
3. Le statut de Signatera était le prédicteur le plus significatif de récidive dans tous les stades pathologiques.
4. Une élimination soutenue de Signatera après l'ACT était associée à un OS de 100% à 24 mois.
Ces résultats soulignent le potentiel de Signatera à améliorer les résultats pour les patients atteints de cancer colorectal grâce à des décisions de traitement personnalisées.
Natera, Inc. (NASDAQ: NTRA) gab beim ESMO-Kongress 2024 neue Daten vom GALAXY-Arm der CIRCULATE-Japan-Studie bekannt. Die Studie, an der 2.240 Patienten mit kolorektalem Krebs im Stadium II-IV beteiligt waren, zeigte die Fähigkeit von Signatera, die gesamte Überlebenszeit (OS) sowie den Nutzen der adjuvanten Chemotherapie (ACT) vorherzusagen. Die wichtigsten Ergebnisse umfassen:
1. Patienten, die positiv auf Signatera getestet wurden, hatten ein 9,68-fach höheres Sterberisiko im Vergleich zu Patienten, die negativ auf Signatera getestet wurden.
2. Signatera-positive Patienten, die ACT erhielten, hatten ein 50% geringeres Sterberisiko.
3. Der Signatera-Status war der wichtigste Prädiktor für das Wiederauftreten in allen pathologischen Stadien.
4. Eine anhaltende Signatera-Clearance nach ACT war mit einem 100% OS über 24 Monate assoziiert.
Diese Ergebnisse unterstreichen das Potenzial von Signatera, die Ergebnisse für Patienten mit kolorektalem Krebs durch personalisierte Behandlungsentscheidungen zu verbessern.
- Signatera demonstrated ability to predict overall survival with a 9.68 hazard ratio
- Signatera-positive patients showed 50% reduction in death risk when treated with adjuvant chemotherapy
- Signatera status was the most significant predictor of recurrence across all pathologic stages
- Sustained Signatera clearance after adjuvant chemotherapy associated with 100% 24-month overall survival
- Large study size of 2,240 patients provides robust data for Signatera's efficacy
- None.
The GALAXY study results represent a significant advancement in colorectal cancer (CRC) management. The data demonstrates Signatera's remarkable ability to predict overall survival and chemotherapy benefit. Key findings include:
- Signatera-positive patients showed a 9.68 times higher risk of death compared to Signatera-negative patients.
- Signatera-positive patients receiving adjuvant chemotherapy (ACT) had a
50% reduced risk of death, surpassing the16% reduction seen in the MOSAIC trial. - Sustained Signatera clearance after ACT correlated with 100% 24-month overall survival.
These results suggest Signatera could revolutionize CRC treatment decisions, potentially sparing Signatera-negative patients from unnecessary chemotherapy while ensuring high-risk patients receive potentially life-saving treatment.
The GALAXY study's findings are groundbreaking for CRC management. The 10-fold survival advantage at 36 months based on ctDNA status is unprecedented. This far exceeds the prognostic value of current biomarkers. The study also validates ctDNA clearance as a surrogate endpoint for long-term outcomes, which could accelerate future clinical trials. Importantly, the data shows Signatera can identify patients who truly benefit from ACT, potentially changing treatment paradigms. The 100% 24-month survival for patients with sustained ctDNA clearance is particularly striking. This could lead to more personalized treatment strategies, potentially improving outcomes while reducing overtreatment in low-risk patients.
The GALAXY study results are highly positive for Natera (NASDAQ: NTRA). The data significantly strengthens Signatera's value proposition in the
- Potential for increased adoption and reimbursement of Signatera in CRC management
- Possible expansion into other cancer types, broadening Natera's market reach
- Enhanced competitive position against other liquid biopsy tests
The ability to predict chemotherapy benefit could lead to substantial healthcare cost savings, further driving adoption. With these results, Natera is well-positioned to capture a larger share of the growing precision oncology market, potentially boosting long-term revenue growth and profitability.
Shows nearly 10x advantage in overall survival at 36 months based on ctDNA status and affirms Signatera’s ability to predict chemotherapy benefit
Shows a
This latest analysis, which will also be published in Nature Medicine on September 16, provides the first evidence of the ability of Signatera-based molecular residual disease (MRD) detection to predict overall survival (OS). The data also demonstrates Signatera’s ability to predict adjuvant chemotherapy (ACT) benefit in resectable CRC, with ctDNA clearance as an indicator of a superior survival benefit compared to no clearance.
In the study, 2,240 patients with stage II–IV CRC were monitored using Signatera after curative-intent surgery with a median follow-up of 23 months. Key takeaways include:
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Signatera status was predictive of overall survival. Signatera-positivity in the post-op MRD window was found to be significantly associated with worse OS compared to Signatera-negative patients (HR: 9.68, p-value < 0.01) with a 36-month OS of
71.80% vs.96.0% , respectively. This 10x advantage in overall survival compares favorably to all known guideline-recommended biomarkers that have HRs for overall survival in a range of 1-4. -
Signatera status was predictive of an overall survival benefit from adjuvant chemotherapy.
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High-risk stage II and stage III-IV patients who were Signatera-positive after surgery and received ACT demonstrated superior OS (adjusted HR: 0.53, p-value = 0.05), corresponding to a
50% reduction in the risk of death when treated with ACT. By comparison, the MOSAIC trial1, which was the last practice-changing study in adjuvant CRC, demonstrated a16% reduction in risk of death (HR: 0.84, p-value = 0.05). - Signatera-negative patients did not derive an OS benefit from ACT (adjusted HR: 0.53, p-value = 0.13).
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High-risk stage II and stage III-IV patients who were Signatera-positive after surgery and received ACT demonstrated superior OS (adjusted HR: 0.53, p-value = 0.05), corresponding to a
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Signatera status remained the most significant predictor of recurrence. Signatera-positivity after surgery was the single most significant prognostic factor associated with inferior DFS (HR 12.08, p-value <0.01) and OS (HR 9.87, p-value <0.01) in a multivariate analysis that included all clinicopathologic risk factors currently in use. This is also reflected by the 36-month DFS difference between Signatera-positive and Signatera-negative patients at
16.7% (95% CI: 12.1–21.9% ) versus83.5% (95% CI:81.2% –85.6% ), respectively. The association of Signatera-positivity with a significantly increased risk for recurrence was observed across all pathologic stages. -
Sustained Signatera clearance after ACT was associated with improved survival. Patients who clear ctDNA and remained Signatera-negative (referred to as “sustained clearance”) had superior survival benefit with 24-month OS of
100% . This compares to patients who cleared ctDNA for a period of time but later become Signatera-positive (referred to as “transient clearance”), with 24-month OS of82% , and patients who did not achieve ctDNA clearance, with 24-month OS of61% . This finding further supports the utility of sustained ctDNA clearance as a surrogate endpoint for long-term outcomes.
“We now have compelling prospective evidence from a large trial of more than 2,200 patients that clearly reinforces the link between MRD status and overall survival,” said Yoshiaki Nakamura, MD, PhD, co-author of the paper and principal investigator of the study from the National Cancer Center Hospital East in Kashiwa,
“The GALAXY data released today builds on an earlier analysis from the same study that was published in Nature Medicine in 2023,” said Minetta Liu, MD, chief medical officer of oncology at Natera. “Introducing 36-month, first-of-its-kind data on overall survival is an important milestone that reinforces the potential to improve outcomes for patients diagnosed with colorectal cancer. The updated data affirms ctDNA status as a critical measure both for prognosis and for predicting which patients may truly benefit from adjuvant chemotherapy.”
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 more than 70 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 200 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.
References
- Thierry André et al., Improved Overall Survival With Oxaliplatin, Fluorouracil, and Leucovorin As Adjuvant Treatment in Stage II or III Colon Cancer in the MOSAIC Trial. JCO 27, 3109-3116(2009). DOI:10.1200/JCO.2008.20.6771
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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.
FAQ
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