Natera Announces Successful Readout of Randomized, Phase III CALGB (Alliance) / SWOG 80702 Clinical Trial in Colorectal Cancer
Natera (NTRA) announced significant results from two clinical trials in colorectal cancer (CRC). The Phase III CALGB/SWOG 80702 study, involving ~1,000 patients, demonstrated that Signatera-positive patients treated with both chemotherapy and celecoxib showed a 40% improvement in overall survival compared to chemotherapy alone.
Key findings revealed that adding celecoxib to standard chemotherapy significantly improved disease-free survival (DFS) in Signatera-positive patients, with a three-year DFS of 44.1% versus 26.6%. The study also confirmed Signatera's effectiveness in predicting recurrence.
Additionally, the ALTAIR clinical trial, studying 243 Signatera-positive patients, showed promising results for stage IV CRC patients treated with Trifluridine/Tipiracil (FTD/TPI). These patients demonstrated a median DFS of 9.76 months compared to 3.96 months in the placebo group, marking a significant advancement in personalized medicine for CRC treatment.
Natera (NTRA) ha annunciato risultati significativi da due studi clinici sul cancro colorettale (CRC). Lo studio di Fase III CALGB/SWOG 80702, che ha coinvolto circa 1.000 pazienti, ha dimostrato che i pazienti Signatera-positivi trattati con chemioterapia e celecoxib hanno mostrato un miglioramento del 40% nella sopravvivenza complessiva rispetto a quelli trattati solo con chemioterapia.
I risultati chiave hanno rivelato che l'aggiunta di celecoxib alla chemioterapia standard ha migliorato significativamente la sopravvivenza libera da malattia (DFS) nei pazienti Signatera-positivi, con una DFS a tre anni del 44,1% rispetto al 26,6%. Lo studio ha anche confermato l'efficacia di Signatera nel predire le recidive.
Inoltre, il trial clinico ALTAIR, che ha studiato 243 pazienti Signatera-positivi, ha mostrato risultati promettenti per i pazienti con CRC di stadio IV trattati con Trifluridina/Tipiracil (FTD/TPI). Questi pazienti hanno dimostrato una DFS mediana di 9,76 mesi rispetto ai 3,96 mesi nel gruppo placebo, segnando un avanzamento significativo nella medicina personalizzata per il trattamento del CRC.
Natera (NTRA) anunció resultados significativos de dos ensayos clínicos sobre el cáncer colorrectal (CRC). El estudio de Fase III CALGB/SWOG 80702, que involucró a aproximadamente 1.000 pacientes, demostró que los pacientes Signatera-positivos tratados con quimioterapia y celecoxib mostraron una mejora del 40% en la supervivencia general en comparación con la quimioterapia sola.
Los hallazgos clave revelaron que añadir celecoxib a la quimioterapia estándar mejoró significativamente la supervivencia libre de enfermedad (DFS) en pacientes Signatera-positivos, con un DFS a tres años del 44,1% frente al 26,6%. El estudio también confirmo la efectividad de Signatera para predecir la recurrencia.
Además, el ensayo clínico ALTAIR, que estudió a 243 pacientes Signatera-positivos, mostró resultados prometedores para pacientes con CRC en estadio IV tratados con Trifluridina/Tipiracil (FTD/TPI). Estos pacientes demostraron una DFS mediana de 9,76 meses comparada con los 3,96 meses en el grupo de placebo, marcando un avance significativo en la medicina personalizada para el tratamiento del CRC.
Natera (NTRA)는 대장암(CRC)에 대한 두 가지 임상 시험에서 중요한 결과를 발표했습니다. 약 1,000명의 환자가 참여한 3상 CALGB/SWOG 80702 연구에서, Signatera-양성 환자들은 화학요법과 세레콕시브 치료를 받았을 때 단독 화학요법 치료를 받은 환자들에 비해 전체 생존율이 40% 향상된 것으로 나타났습니다.
주요 결과는 세레콕시브를 표준 화학요법에 추가하는 것이 Signatera-양성 환자들의 질병 무병 생존율(DFS)을 크게 향상시켰으며, 3년 DFS가 44.1%로 26.6%에 비해 높다는 사실을 밝혔습니다. 이 연구는 또한 재발 예측에 있어 Signatera의 효과를 확인했습니다.
또한 243명의 Signatera-양성 환자를 조사한 ALTAIR 임상 시험에서는 Trifluridine/Tipiracil (FTD/TPI)로 치료 받은 IV기 CRC 환자들에게 유망한 결과가 나타났습니다. 이 환자들은 위약 그룹의 3.96개월에 비해 9.76개월의 중위 DFS를 보였으며, CRC 치료를 위한 개인 맞춤 의학에서 중요한 진전을 의미합니다.
Natera (NTRA) a annoncé des résultats significatifs de deux essais cliniques sur le cancer colorectal (CRC). L'étude de Phase III CALGB/SWOG 80702, impliquant environ 1.000 patients, a démontré que les patients Signatera-positifs traités avec une chimiothérapie et du célecoxib ont montré une amélioration de 40% de la survie globale par rapport à ceux traités uniquement par chimiothérapie.
Les résultats clés ont révélé que l'ajout de célecoxib à la chimiothérapie standard améliorait significativement la survie sans maladie (DFS) chez les patients Signatera-positifs, avec une DFS sur trois ans de 44,1% contre 26,6%. L'étude a également confirmé l'efficacité de Signatera dans la prédiction des rechutes.
De plus, l'essai clinique ALTAIR, qui a étudié 243 patients Signatera-positifs, a montré des résultats prometteurs pour les patients atteints de CRC stade IV traités avec Trifluridine/Tipiracil (FTD/TPI). Ces patients ont montré une DFS médiane de 9,76 mois par rapport à 3,96 mois dans le groupe placebo, marquant une avancée significative dans la médecine personnalisée pour le traitement du CRC.
Natera (NTRA) gab bedeutende Ergebnisse aus zwei klinischen Studien zu kolorektalem Krebs (CRC) bekannt. Die Phase-III-Studie CALGB/SWOG 80702, an der etwa 1.000 Patienten beteiligt waren, zeigte, dass Signatera-positive Patienten, die sowohl mit Chemotherapie als auch mit Celecoxib behandelt wurden, eine Verbesserung der Gesamtüberlebensrate um 40% im Vergleich zur alleinigen Chemotherapie erzielten.
Wichtige Ergebnisse zeigten, dass die Hinzufügung von Celecoxib zur Standardchemotherapie die krankheitsfreie Überlebenszeit (DFS) bei Signatera-positiven Patienten signifikant verbesserte, mit einer dreijährigen DFS von 44,1% gegenüber 26,6%. Die Studie bestätigte auch die Wirksamkeit von Signatera bei der Vorhersage von Rückfällen.
Zusätzlich zeigte die ALTAIR-Studie, die 243 Signatera-positive Patienten untersuchte, vielversprechende Ergebnisse für Patienten mit im Stadium IV пребасрелалным (FTD/TPI) behandelt wurden. Diese Patienten hatten eine mediane DFS von 9,76 Monaten im Vergleich zu 3,96 Monaten in der Placebo-Gruppe, was einen bedeutenden Fortschritt in der personalisierten Medizin für die CRC-Behandlung darstellt.
- 40% improvement in overall survival for Signatera-positive patients with celecoxib + chemotherapy
- Significant DFS improvement (44.1% vs 26.6%) in Signatera-positive patients
- Strong predictive capability of Signatera for cancer recurrence confirmed
- Significant benefit in stage IV patients (9.76 vs 3.96 months DFS) with FTD/TPI treatment
- ALTAIR trial's overall results did not reach statistical significance (HR, 0.79; P = 0.107)
Insights
The CALGB/SWOG 80702 trial results represent a paradigm shift in colorectal cancer treatment personalization. The study of approximately 1,000 patients demonstrates the powerful predictive capabilities of Signatera in identifying patients who will benefit from additional treatment. The incorporation of celecoxib, an affordable and well-tolerated NSAID, alongside standard FOLFOX chemotherapy showed remarkable improvements in both disease-free and overall survival for Signatera-positive patients.
The data is particularly compelling for several reasons: First, the hazard ratio of 0.55 for DFS and 0.58 for OS represents a substantial clinical benefit. Second, the clear stratification between Signatera-positive and negative patients (HR 7.14 for DFS) demonstrates the test's exceptional predictive value. Third, this represents the first major advancement in adjuvant colorectal cancer treatment in over two decades.
The complementary ALTAIR trial data further strengthens Signatera's utility, particularly in stage IV patients where FTD/TPI treatment showed a significant improvement in DFS (9.76 vs 3.96 months). This multi-trial validation establishes Signatera as a important tool in treatment decision-making and represents a major step forward in precision oncology.
These landmark trial results substantially enhance Natera's market position in the $50+ billion cancer diagnostics market. The successful validation of Signatera in a large-scale randomized trial creates multiple value drivers: First, it establishes Signatera as an essential tool for treatment optimization in colorectal cancer, potentially expanding its adoption across major cancer centers. Second, the use of an affordable, generic drug (celecoxib) as the companion therapy significantly reduces barriers to adoption and could accelerate insurance coverage.
The dual validation from both CALGB/SWOG and ALTAIR trials strengthens Natera's competitive moat in minimal residual disease (MRD) testing. The robust predictive value demonstrated in these trials, particularly the striking hazard ratios, positions Signatera as a potential standard of care in colorectal cancer management. This could drive substantial market share gains and support premium pricing for the test.
The implications for Natera's growth trajectory are significant, as colorectal cancer represents a major market opportunity with over 150,000 new cases annually in the US alone. The ability to stratify patients for targeted therapy optimization could drive both testing volumes and reimbursement rates higher.
Readout of ~1K patients at ASCO GI 2025 demonstrates that Signatera™ positive patients treated with both chemotherapy and celecoxib had a
Additional ASCO GI poster highlights data from the
This first-of-its-kind study evaluated whether Signatera-positive patients benefit from an escalation in adjuvant treatment. In the trial, Signatera was used to evaluate the benefit of adding celecoxib, a non-steroidal anti-inflammatory drug (NSAID), to standard of care (SOC) adjuvant chemotherapy with FOLFOX in the management of stage III colorectal cancer (CRC). The pre-specified analysis included approximately 1,000 patients with available post-surgical plasma samples, who were randomized to receive FOLFOX (+/-) celecoxib.
Key findings included:
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Signatera-positivity after surgery was predictive of a disease-free survival (DFS) and overall survival (OS) benefit with the addition of celecoxib to adjuvant FOLFOX. The addition of celecoxib to SOC chemotherapy significantly improved DFS compared to placebo (HR 0.55,
95% CI 0.39-0.80; p=0.001) among Signatera-positive patients with a three-year DFS of44.1% versus26.6% . Similar results were seen for OS (HR 0.58,95% CI 0.38-0.90; p=0.013). No survival benefit was seen by adding celecoxib to chemotherapy in Signatera-negative patients. -
Signatera status after surgery and prior to starting adjuvant therapy was highly predictive of recurrence. Signatera-positivity was significantly associated with worse DFS (HR 7.14,
95% CI: 5.54-9.21; p<0.0001) and OS (HR 6.72,95% CI: 4.91-9.18; p<0.0001).
“The results from the CALGB (Alliance) / SWOG 80702 study mark an unprecedented moment in personalized medicine for patients with colorectal cancer,” said Alexey Aleshin, M.D., corporate chief medical officer and general manager of oncology for Natera. “We demonstrated Signatera’s ability to predict a benefit in both disease-free survival and overall survival for Signatera-positive patients from the addition of celecoxib, an extremely accessible, affordable, and well-tolerated therapy. These data also offer compelling evidence to address an unmet need in adjuvant colorectal cancer treatment, where there has not been a new drug approval in over 20 years.”
The results of the randomized, double-blind
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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250124878004/en/
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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