Natera Announces Completion of Signatera™ Analysis from the CALGB (Alliance)/SWOG 80702 Randomized, Phase III Clinical Trial in Colorectal Cancer
Natera (NASDAQ: NTRA) announced the completion of a study using Signatera from the CALGB (Alliance)/SWOG 80702 randomized, phase III clinical trial. This study evaluated the benefit of adding celecoxib to standard postoperative treatment FOLFOX in stage III colorectal cancer (CRC) patients. The analysis included 1,011 patients with post-surgical plasma samples, focusing on Signatera’s ability to identify a subgroup of patients who may benefit from celecoxib addition. Primary and secondary endpoints were disease-free survival (DFS) and overall survival (OS), respectively. Although celecoxib addition did not significantly improve DFS, NSAIDs like celecoxib have shown promise in benefiting certain CRC subpopulations. Results will be presented at the ASCO GI symposium in January 2024.
Natera (NASDAQ: NTRA) ha annunciato il completamento di uno studio che ha utilizzato Signatera nell'ambito dello studio randomizzato, fase III CALGB (Alliance)/SWOG 80702. Questo studio ha valutato i benefici di aggiungere celecoxib al trattamento post-operatorio standard FOLFOX nei pazienti con carcinoma colorettale (CRC) di stadio III. L'analisi ha incluso 1.011 pazienti con campioni di plasma post-operatorio, concentrandosi sulla capacità di Signatera di identificare un sottogruppo di pazienti che potrebbero beneficiare dall'aggiunta di celecoxib. Gli endpoint primari e secondari erano la sopravvivenza libera da malattia (DFS) e la sopravvivenza generale (OS), rispettivamente. Sebbene l'aggiunta di celecoxib non abbia migliorato significativamente il DFS, gli FANS come il celecoxib hanno mostrato promesse nel beneficio di certe subpopolazioni di CRC. I risultati saranno presentati al simposio ASCO GI nel gennaio 2024.
Natera (NASDAQ: NTRA) anunció la finalización de un estudio que utilizó Signatera en el ensayo clínico aleatorio de fase III CALGB (Alliance)/SWOG 80702. Este estudio evaluó el beneficio de añadir celecoxib al tratamiento postoperatorio estándar FOLFOX en pacientes con cáncer colorrectal (CCR) en estadio III. El análisis incluyó a 1.011 pacientes con muestras de plasma postquirúrgico, centrándose en la capacidad de Signatera para identificar un subgrupo de pacientes que podrían beneficiarse de la adición de celecoxib. Los puntos finales primarios y secundarios fueron la supervivencia libre de enfermedad (DFS) y la supervivencia general (OS), respectivamente. Aunque la adición de celecoxib no mejoró significativamente el DFS, los AINE como el celecoxib han mostrado potencial en beneficiar a ciertas subpoblaciones de CCR. Los resultados se presentarán en el simposio ASCO GI en enero de 2024.
네일러 (NASDAQ: NTRA)는 CALGB (Alliance)/SWOG 80702 무작위, 3상 임상 시험에서 Signatera를 사용한 연구가 완료되었음을 발표했습니다. 이 연구는 III기 대장암 (CRC) 환자에게 표준 수술 후 치료 FOLFOX에 celecoxib을 추가하는 것의 이점을 평가했습니다. 분석에는 1,011명의 수술 후 혈장 샘플을 가진 환자가 포함되었으며, Signatera가 celecoxib 추가로 혜택을 받을 수 있는 환자 하위 그룹을 식별하는 능력에 초점을 맞췄습니다. 주요 및 부차적 목표는 각각 질병 없는 생존율 (DFS)와 전체 생존율 (OS)였습니다. celecoxib 추가가 DFS를 유의미하게 개선하지는 않았지만, celecoxib와 같은 NSAID는 특정 CRC 서브집단에 혜택을 줄 가능성을 보여주었습니다. 결과는 2024년 1월 ASCO GI 심포지엄에서 발표될 예정입니다.
Natera (NASDAQ: NTRA) a annoncé l'achèvement d'une étude utilisant Signatera dans le cadre de l'essai clinique randomisé de phase III CALGB (Alliance)/SWOG 80702. Cette étude a évalué l'avantage d'ajouter celecoxib au traitement postopératoire standard FOLFOX chez les patients atteints de cancer colorectal (CCR) au stade III. L'analyse a inclus 1.011 patients avec des échantillons de plasma post-chirurgical, en se concentrant sur la capacité de Signatera à identifier un sous-groupe de patients susceptibles de bénéficier de l'ajout de celecoxib. Les principaux et secondaires étaient la survie sans maladie (DFS) et la survie globale (OS), respectivement. Bien que l'ajout de celecoxib n'ait pas amélioré significativement le DFS, les AINS comme le celecoxib ont montré des promesses dans l'apport d'avantages à certaines sous-populations de CCR. Les résultats seront présentés au symposium ASCO GI en janvier 2024.
Natera (NASDAQ: NTRA) gab den Abschluss einer Studie bekannt, die Signatera aus der randomisierten, Phase-III-Klinikstudie CALGB (Alliance)/SWOG 80702 verwendete. Diese Studie bewertete den Nutzen der Hinzufügung von celecoxib zur Standardbehandlung nach der Operation FOLFOX bei Patienten mit kolorektalem Krebs (CRC) im Stadium III. Die Analyse umfasste 1.011 Patienten mit postchirurgischen Plasma-Proben und konzentrierte sich auf die Fähigkeit von Signatera, eine Untergruppe von Patienten zu identifizieren, die von der Hinzufügung von celecoxib profitieren könnten. Die primären und sekundären Endpunkte waren das krankheitsfreie Überleben (DFS) und das Gesamtüberleben (OS). Obwohl die Hinzufügung von celecoxib DFS nicht signifikant verbesserte, haben NSAIDs wie celecoxib in bestimmten CRC-Unterpopulationen vielversprechende Vorteile gezeigt. Die Ergebnisse werden im Januar 2024 auf dem ASCO GI-Symposium präsentiert.
- Completion of a significant study involving >1,000 patients.
- Potential to identify subgroups benefiting from celecoxib addition using Signatera.
- Upcoming presentation of results at ASCO GI 2024.
- Addition of celecoxib did not significantly improve disease-free survival.
Insights
This study represents a significant milestone in personalized cancer treatment, analyzing over 1,000 colorectal cancer patients to evaluate Signatera's potential in guiding treatment decisions. The completion of this analysis from the CALGB/SWOG 80702 trial is particularly noteworthy as it explores the possibility of identifying specific patient subgroups who could benefit from adding celecoxib to standard FOLFOX chemotherapy.
The study's importance stems from several key factors:
- It's the first large-scale randomized trial investigating Signatera's role in treatment selection
- It addresses an unmet need in colorectal cancer treatment, where no new drugs have been approved in over 20 years
- It could potentially establish a new biomarker-guided approach to treatment optimization
The upcoming presentation at ASCO GI in January 2024 could significantly impact Natera's market position if the results demonstrate Signatera's effectiveness in patient stratification. This could expand the test's clinical utility and drive increased adoption in oncology practices.
First-of-its-kind study of >1K patients evaluating the impact of adjuvant treatment escalation in patients tested with Signatera™; results to be presented at ASCO GI in Jan. 2025
This pre-specified analysis includes
Additional details on CALGB (Alliance)/SWOG 80702
In the CALGB (Alliance)/SWOG 80702 trial, patients were randomized to receive standard-of-care adjuvant chemotherapy FOLFOX (+/-) celecoxib, a non-steroidal anti-inflammatory drug (NSAID). Although the results showed that the addition of celecoxib did not significantly improve disease-free survival1, NSAIDs have shown promise in benefiting certain subpopulations in CRC, including reducing the risk of developing precancerous colon polyps. In addition, NSAIDs are typically well-tolerated, widely available, and generally low-cost.
“We see this trial as one of the most important in the space given its size, randomized design, and indication,” said Alexey Aleshin, MD, MBA, general manager of oncology and chief medical officer of Natera. “There is a clear need for additional adjuvant treatment options for patients with colorectal cancer as there has not been a new drug approval in the space in over 20 years. We are hopeful that Signatera-guided therapy selection can help open the door to effective treatment options in CRC, personalized to the patients who are most likely to benefit.”
Results have been accepted as a late-breaking abstract to be shared at the American Society of Clinical Oncology Gastrointestinal Symposium (ASCO GI), which takes place from Jan. 23-25, 2024 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 more than 90 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
- Meyerhardt JA, Shi Q, Fuchs CS, et al. Effect of Celecoxib vs Placebo Added to Standard Adjuvant Therapy on Disease-Free Survival Among Patients With Stage III Colon Cancer: The CALGB/SWOG 80702 (Alliance) Randomized Clinical Trial. JAMA. 2021;325(13):1277-1286. doi:10.1001/jama.2021.2454
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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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