Policy & Regulation
GRAIL reports first patient tested with blood-based assay in TROPION-Lung12 Phase 3 study
19 November 2024 -

GRAIL Inc (Nasdaq: GRAL), a US-based healthcare company involved in early cancer detection, announced on Monday 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 assessing adjuvant treatment regimens in patients with Stage I adenocarcinoma NSCLC.

UK-based AstraZeneca (LSE/STO/Nasdaq:AZN) is sponsoring the study in partnership with Japan-based Daiichi Sankyo (TSE: 4568).

Carried out under an FDA-approved Investigational Device Exemption application held by GRAIL, the study leverages GRAIL's targeted methylation platform to detect ctDNA. With GRAIL's blood-only approach, tissue analysis and bespoke panel development are not needed, enabling simple integration into pharmaceutical clinical trial workflows. Patients will be screened with the GRAIL assay prior to surgery to inform eligibility for post-surgery randomisation to an adjuvant treatment regimen.

Harpal Kumar, GRAIL president, International Business & Biopharma, said: "GRAIL's ctDNA detection approach, which does not require tumour 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."

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