GRAIL Announces First Patient Tested With Blood-Based Assay in Global Phase 3 Adjuvant Lung Cancer Study
GRAIL announced the first patient testing in the global TROPION-Lung12 Phase 3 study using their Non-Small Cell Lung Cancer (NSCLC) ctDNA Assay. The study, conducted under FDA approval, evaluates adjuvant treatments in Stage I adenocarcinoma NSCLC patients. The trial is sponsored by AstraZeneca in collaboration with Daiichi Sankyo.
GRAIL's blood-based methylation platform detects ctDNA without requiring tissue analysis, streamlining integration into clinical trials. Patients will be screened pre-surgery to determine eligibility for post-surgery treatment. This marks one of the first uses of ctDNA assay in early-stage lung cancer trials to identify patients who may benefit from additional treatment.
GRAIL ha annunciato il primo test su pazienti nello studio globale TROPION-Lung12 di Fase 3 utilizzando il loro Assay ctDNA per il Carcinoma Polmonare Non a Piccole Cellule (NSCLC). Lo studio, condotto con l'approvazione della FDA, valuta i trattamenti adiuvanti nei pazienti con adenocarcinoma NSCLC di Stadio I. La sperimentazione è sponsorizzata da AstraZeneca in collaborazione con Daiichi Sankyo.
La piattaforma di metilazione basata su sangue di GRAIL rileva il ctDNA senza richiedere un'analisi tessutale, semplificando l'integrazione nelle sperimentazioni cliniche. I pazienti saranno sottoposti a screening prima dell'intervento chirurgico per determinare l'idoneità al trattamento post-operatorio. Questo rappresenta uno dei primi utilizzi dell'assay ctDNA nelle sperimentazioni sul cancro ai polmoni in fase iniziale per identificare i pazienti che potrebbero beneficiare di un trattamento aggiuntivo.
GRAIL anunció la primera prueba en pacientes en el estudio global TROPION-Lung12 de Fase 3 utilizando su Ensayo de ctDNA para el Cáncer de Pulmón No de Pequeñas Células (NSCLC). El estudio, realizado bajo la aprobación de la FDA, evalúa tratamientos adyuvantes en pacientes con adenocarcinoma NSCLC en Etapa I. El ensayo está patrocinado por AstraZeneca en colaboración con Daiichi Sankyo.
La plataforma de metilación basada en sangre de GRAIL detecta ctDNA sin requerir análisis de tejido, optimizando la integración en ensayos clínicos. Los pacientes serán evaluados antes de la cirugía para determinar su elegibilidad para el tratamiento postoperatorio. Esto marca uno de los primeros usos del ensayo ctDNA en ensayos de cáncer de pulmón en etapa temprana para identificar a los pacientes que podrían beneficiarse de un tratamiento adicional.
GRAIL은 비소세포폐암(NSCLC) ctDNA 분석을 사용한 글로벌 TROPION-Lung12 3상 연구에서 첫 번째 환자 테스트를 발표했습니다. FDA의 승인을 받은 이 연구는 1기 선암 NSCLC 환자에서 보조 치료를 평가합니다. 이 시험은 AstraZeneca가 Daiichi Sankyo와 협력하여 후원하고 있습니다.
GRAIL의 혈액 기반 메틸화 플랫폼은 조직 분석 없이 ctDNA를 감지하여 임상 시험에 통합하는 과정을 간소화합니다. 환자들은 수술 전 스크리닝을 통해 수술 후 치료에 대한 적격성을 판단받습니다. 이는 초기 단계 폐암 임상 시험에서 추가 치료의 혜택을 받을 수 있는 환자를 식별하기 위한 ctDNA 분석의 첫 번째 사용 중 하나입니다.
GRAIL a annoncé le premier test patient dans l'étude mondiale TROPION-Lung12 de phase 3 utilisant leur Essai ctDNA pour le Cancer du Poumon Non à Petites Cellules (NSCLC). L'étude, réalisée sous l'approbation de la FDA, évalue les traitements adjuvants chez les patients atteints d'adénocarcinome NSCLC au stade I. L'essai est parrainé par AstraZeneca en collaboration avec Daiichi Sankyo.
La plateforme de méthylation basée sur le sang de GRAIL détecte le ctDNA sans nécessiter d'analyse tissulaire, facilitant ainsi l'intégration dans les essais cliniques. Les patients seront dépistés avant la chirurgie pour déterminer leur éligibilité à un traitement post-opératoire. Cela marque l'un des premiers usages de l'essai ctDNA dans les essais de cancer du poumon à un stade précoce pour identifier les patients qui pourraient bénéficier d'un traitement supplémentaire.
GRAIL hat die erste Patiententestung in der globalen TROPION-Lung12-Studie der Phase 3 angekündigt, in der ihr ctDNA-Assay für nicht-kleinzelliges Lungenkarzinom (NSCLC) verwendet wird. Die Studie, die unter FDA-Genehmigung durchgeführt wird, bewertet adjuvante Behandlungen bei Patienten mit Adenokarzinom im Stadium I (NSCLC). Die Studie wird von AstraZeneca in Zusammenarbeit mit Daiichi Sankyo gesponsert.
Die blutbasierte Methylierungsplattform von GRAIL erkennt ctDNA, ohne eine Gewebeanalyse zu erfordern, was die Integration in klinische Studien vereinfacht. Die Patienten werden vor der Operation gescreent, um ihre Eignung für die postoperative Behandlung zu bestimmen. Dies ist eines der ersten Male, dass ctDNA-Assays in frühen Lungenkrebsstudien verwendet werden, um Patienten zu identifizieren, die von einer zusätzlichen Behandlung profitieren könnten.
- FDA-approved Investigational Device Exemption obtained for the ctDNA Assay
- Strategic collaboration with major pharmaceutical companies (AstraZeneca and Daiichi Sankyo)
- Innovative blood-only approach eliminates need for tissue analysis
- Successfully initiated Phase 3 clinical trial for lung cancer screening
- None.
Insights
The initiation of patient testing in TROPION-Lung12 represents a significant milestone in early-stage lung cancer diagnostics. GRAIL's blood-based ctDNA assay could revolutionize patient selection for adjuvant therapy by offering a less invasive alternative to tissue biopsies. The collaboration with AstraZeneca and Daiichi Sankyo adds substantial credibility to this Phase 3 study.
The key differentiator is GRAIL's targeted methylation platform, which eliminates the need for tissue analysis and custom panel development. This could significantly streamline the diagnostic process and accelerate treatment decisions. For Stage I adenocarcinoma NSCLC patients, early identification of those at higher risk of recurrence could lead to more targeted and effective treatment strategies.
The FDA's approval of the Investigational Device Exemption further validates the potential of this approach. Previous performance data published in the Journal of Thoracic Oncology provides a strong foundation for this larger-scale validation study.
This Phase 3 trial marks a important commercial milestone for GRAIL, particularly in expanding its biopharma partnerships. The collaboration with pharmaceutical giants AstraZeneca and Daiichi Sankyo could significantly accelerate market adoption of GRAIL's diagnostic platform. Success in this trial could position GRAIL as a leader in companion diagnostics for cancer treatment.
The companion diagnostic (CDx) market represents a substantial revenue opportunity, with pharmaceutical companies increasingly seeking precision medicine approaches. GRAIL's blood-based testing platform could capture significant market share by offering a more efficient and scalable solution compared to traditional tissue-based methods.
The study, which is being conducted under an FDA-approved Investigational Device Exemption application, held by GRAIL, leverages GRAIL's targeted methylation platform to detect ctDNA. With GRAIL's blood-only approach, tissue analysis and bespoke panel development are not required, enabling simple integration into pharmaceutical clinical trial workflows. In TROPION-Lung12, patients will be screened with the GRAIL assay prior to surgery to inform eligibility for post-surgery randomization to an adjuvant treatment regimen (NCT06564844). Assay performance was previously reported in the Journal of Thoracic Oncology and presented at the 2023 North America Conference on Lung Cancer.
"We're excited to continue our strategic collaboration with AstraZeneca with the use of our novel assay in the TROPION-Lung12 study. We hope this study will further demonstrate the potential of GRAIL's Methylation Platform to enhance patient selection for cancer treatment," said Harpal Kumar, President, International Business & Biopharma, at GRAIL. "GRAIL's ctDNA detection approach, which does not require tumor tissue, has the potential to offer oncologists a rapid, accessible method to help refine patients' diagnostic and prognostic profiles for better guided cancer therapy. This is among the first times a ctDNA assay has been used in a clinical trial of early-stage lung cancer patients to identify those most likely to benefit from further treatment. As such, we hope this approach could provide substantial additional benefit for patients diagnosed with Stage 1 lung cancer."
"In TROPION-Lung12, screening for ctDNA is intended to identify the patients at an increased risk of disease recurrence after surgery and thus most likely to benefit from adjuvant therapy," said Cristian Massacesi, MD, Chief Medical Officer and Oncology Chief Development Officer, AstraZeneca. "The novel strategy we are deploying in this trial illustrates our commitment to both detect cancer earlier and use those early insights to enable more personalized treatment decisions for the benefit of patients."
In 2022, GRAIL announced a broad strategic collaboration with AstraZeneca to develop and commercialize companion diagnostic (CDx) assays for use with AstraZeneca's therapies. GRAIL is committed to leveraging its blood-based methylation testing for patient care by developing fit-for-purpose diagnostics to enable precision oncology strategies with biopharma partners.
About GRAIL
GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art machine learning, software, and automation to detect and identify multiple deadly cancer types in earlier stages. GRAIL's targeted methylation-based platform can support the continuum of care for screening and precision oncology, including multi-cancer early detection in symptomatic patients, risk stratification, minimal residual disease detection, biomarker subtyping, treatment and recurrence monitoring. GRAIL is headquartered in
For more information, visit grail.com.
Laboratory/Test Information
GRAIL's clinical laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and accredited by the College of American Pathologists. GRAIL's clinical laboratory is regulated under CLIA to perform high-complexity testing. GRAIL's current product offerings have not been cleared or approved by the
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Forward-looking statements relate to the future and, accordingly, are subject to inherent uncertainties, risks, and changes in circumstances that are difficult to predict and many of which are outside of GRAIL's control. Although GRAIL believes the expectations and projections expressed or implied by the forward-looking statements are reasonable, GRAIL cannot guarantee future results, level of activity, performance, or achievements. GRAIL's actual results and financial condition may differ materially from those indicated in the forward-looking statements. Except to the extent required by law, GRAIL undertakes no obligation to update any of these forward-looking statements after the date of this press release to conform its prior statements to actual results or revised expectations or to reflect new information or the occurrence of unanticipated events.
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FAQ
What is the purpose of GRAIL's TROPION-Lung12 Phase 3 study for NSCLC (GRAL)?
How does GRAIL's ctDNA Assay work in the Phase 3 lung cancer study (GRAL)?
Who are the partners involved in GRAIL's TROPION-Lung12 Phase 3 study (GRAL)?
