On November 18, 2024 GRAIL, Inc. (Nasdaq: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, reported that the first patient has been tested for eligibility with the investigational GRAIL Non-Small Cell Lung Cancer (NSCLC) ctDNA Assay in the global TROPION-Lung12 Phase 3 study evaluating adjuvant treatment regimens in patients with Stage I adenocarcinoma NSCLC (Press release, Grail, NOV 18, 2024, View Source [SID1234648480]). The study is sponsored by AstraZeneca (LSE/STO/Nasdaq:AZN) in collaboration with Daiichi Sankyo (TSE: 4568).
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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.