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."
Adicet Bio doses first patient in Phase 1 trial of ADI-001 for lupus nephritis
Silo Pharma announces positive preclinical results for SPC-15 in treating stress-related disorders
Endo signs definitive agreement for Paladin Pharma to commercialise Wynzora Cream in Canada
Merck's KEYTRUDA plus chemotherapy receives positive EU opinion for first-line MPM treatment
Sanofi seeks FDA approval for Dupixent in chronic spontaneous urticaria
Azurity Pharmaceuticals' Danziten granted US FDA approval
PTC Therapeutics' gene therapy to treat AADC deficiency receives US FDA accelerated approval
Caliway Biopharmaceuticals' CBL-514 receives EMA Orphan Drug Designation
Jubilant Radiopharma forms collaboration with Simplified Imaging Solutions
Eupraxia Pharmaceuticals reveals additional data from RESOLVE Phase 1b/2a trial of EP-104GI
ResQ Pharma's LipidRescue Kit receives PDUFA date
Johnson & Johnson's nipocalimab granted US FDA Breakthrough Therapy designation
IDEAYA announces IDE034 as development candidate; Secures global license from Biocytogen