The partnership will apply ArcherDX’s personalised cancer monitoring technology to identify minimal residual disease) in patients with early-stage non-small cell lung cancer
AstraZeneca has selected genomic analysis company ArcherDX’s personalised cancer assays for the detection of minimal residual disease in lung cancer trials.
The companies will work together to apply personalised cancer monitoring (PCM) technology to identify minimal residual disease (MRD) in patients with early-stage non-small cell lung cancer (NSCLC).
ArcherDX has already secured breakthrough device designation from the US Food and Drug Administration (FDA) for its PCM technology, which is intended to identify MRD in early-stage cancer patients following surgery.
AstraZeneca oncology R&D executive vice president José Baselga said: “While detecting and monitoring for minimal residual disease has proven challenging in solid tumours, the MERMAID-1 trial and this partnership stand to break new ground in lung cancer.”
AstraZeneca will use ArcherDX’s personalised assay in the recently launched phase III MERMAID-1 trial
AstraZeneca will use ArcherDX’s personalised assay in the recently launched phase III MERMAID-1 trial to assess the efficacy of adjuvant treatment with Imfinzi (durvalumab) plus chemotherapy versus chemotherapy alone on disease-free survival (DFS).
MERMAID-1 is a randomised, multi-centre, double-blind and placebo-controlled phase III trial designed to assess adjuvant Imfinzi in combination with chemotherapy against standard-of-care chemotherapy in around 330 patients diagnosed with resectable (Stage II-III) NSCLC who have undergone complete resection of the primary tumour.
According to the company, the study is in patients with completely resected, stage II and III NSCLC who show evidence of MRD suggesting a high risk of relapse.
The application of ctDNA will help evaluate the presence of MRD and offer significant information on the working of treatment and notifying regarding the prognosis, as well as helps in the detection of cancer returned cancer in the patient.
As per terms of the deal, ArcherDX will conduct whole exome sequencing of NSCLC patient samples and generate sensitive, personalised ctDNA assays to assess for MRD, which remains after a patient’s successful surgery.
The ongoing development of these assays is said to be informed by the TRACERx study, funded by Cancer Research UK and led by UCL and the Francis Crick Institute.
Imfinzi is being assessed in a broad development programme in lung cancer with various ongoing phase III studies in earlier stages of NSCLC in potentially curative settings.
ArcherDX CEO and co-founder Jason Myers said: “While there has been progress in improving adoption of precision oncology for patients with late-stage cancers, there is a pressing need to accelerate access to precision oncology for all patients diagnosed with cancer regardless of the stage or location of the care setting.”
Recently, ArcherDX has secured breakthrough device designation from the US Food and Drug Administration (FDA) for its next-generation sequencing (NGS) device, which is currently under development.