GRAIL, Inc. has announced that the first patient has been tested with its investigational Non-Small Cell Lung Cancer (NSCLC) ctDNA Assay in AstraZeneca's global TROPION-Lung12 Phase 3 study. This trial is evaluating adjuvant treatment regimens in patients with Stage I adenocarcinoma NSCLC and is being conducted under an FDA-approved Investigational Device Exemption application held by GRAIL.
The TROPION-Lung12 trial (NCT06564844) leverages GRAIL's targeted methylation platform to detect circulating tumor DNA (ctDNA). This blood-only approach eliminates the need for tissue analysis and bespoke panel development, streamlining integration into pharmaceutical clinical trial workflows. Patients will be screened with the GRAIL assay before surgery to determine their eligibility for post-surgery randomization to an adjuvant treatment regimen.
Potential Impact on Patient Selection
"We're excited to continue our strategic collaboration with AstraZeneca with the use of our novel assay in the TROPION-Lung12 study," said Harpal Kumar, President, International Business & Biopharma, at GRAIL. "We hope this study will further demonstrate the potential of GRAIL's Methylation Platform to enhance patient selection for cancer treatment."
The ctDNA detection approach, which doesn't require tumor tissue, offers oncologists a rapid, accessible method to refine patients' diagnostic and prognostic profiles for better-guided cancer therapy. This marks one of the first instances where a ctDNA assay is used in a clinical trial of early-stage lung cancer patients to identify those most likely to benefit from further treatment. The hope is that this approach could provide substantial additional benefit for patients diagnosed with Stage 1 lung cancer.
Identifying Patients at Risk of Recurrence
Cristian Massacesi, MD, Chief Medical Officer and Oncology Chief Development Officer at AstraZeneca, stated, "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." He added that the strategy deployed in this trial illustrates their commitment to both detect cancer earlier and use those early insights to enable more personalized treatment decisions for the benefit of patients.
Collaboration for Companion Diagnostics
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.
Assay performance was previously reported in the Journal of Thoracic Oncology and presented at the 2023 North America Conference on Lung Cancer.
