GRAIL Announces First Patient Tested With Blood-Based Assay in Global Phase 3 Adjuvant Lung Cancer Study

MENLO PARK, Calif. , Nov. 18 , 2024 /PRNewswire/ -- GRAIL, Inc.

(Nasdaq: GRAL ), a healthcare company whose mission is to detect cancer early when it can be cured, today announced 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. The study is sponsored by AstraZeneca (LSE/STO/Nasdaq: AZN ) in collaboration with Daiichi Sankyo (TSE: 4568). 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 canc.