AstraZeneca collaborates with ArcherDX to use personalised cancer assays to detect minimal residual disease in lung cancer trials

Collaboration to focus on newly launched global Phase III MERMAID-1 trial for patients with resected, early-stage non-small cell lung cancer

AstraZeneca will collaborate with ArcherDX, a genomic analysis company focused on precision oncology, to use personalised cancer monitoring to detect minimal residual disease (MRD) in patients with early-stage non-small cell lung cancer (NSCLC).

ArcherDX’s personalised assay will be used in AstraZeneca’s recently launched Phase III MERMAID-1 trial to evaluate the effect of adjuvant treatment with Imfinzi (durvalumab) plus chemotherapy versus chemotherapy alone on disease-free survival (DFS). The trial is in patients with completely resected, Stage II and III NSCLC who show evidence of MRD suggesting a high risk of relapse.

MRD describes a very small number of otherwise undetectable cancer cells that shed circulating tumour DNA (ctDNA) in the blood. Monitoring for the presence of MRD using ctDNA may provide valuable information on how well a treatment is working, inform prognosis, and detect if a patient’s cancer has returned. Ultimately, MRD detection may enable physicians to intervene earlier and tailor the best treatment options for individual cancer patients.

Charles Swanton, MD, PhD, Professor at UCL and the Francis Crick Institute, Chief Clinician at Cancer Research UK, leader of Tracking Cancer Evolution through Therapy (Rx) (TRACERx) and international coordinating investigator in the MERMAID-1 trial, said: “MERMAID-1 is a novel randomised trial using ctDNA to identify patients at high risk of recurrence after surgery who may benefit from intervention with immunotherapy. We hope this approach will lead to better patient outcomes by intensifying treatment for patients most likely to relapse, while avoiding additional chemotherapy after surgery when not needed.”

José Baselga, Executive Vice President of Oncology R&D, 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. This innovative endeavour is reflective of our strategy to improve cancer outcomes by treating patients as early as possible. It is in this early setting that the chance of cure is higher and identifying personalised, effective treatments could increase survival and improve quality of life.”

Jason Myers, Chief Executive Officer and co-founder of ArcherDX, 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. AstraZeneca shares this critical mission, and we are pleased to partner with them in the development of biomarker-driven therapies and the expansion of personalised cancer monitoring for all patients.”

Under the terms of the agreement, ArcherDX will perform whole exome sequencing of NSCLC patient samples and generate highly sensitive, personalised ctDNA assays to test for MRD that remains after a patient’s successful surgery. The ongoing development of these assays is informed by the TRACERx study, funded by Cancer Research UK and led by UCL and the Francis Crick Institute.

Imfinzi is being tested in an extensive development programme in lung cancer with several ongoing Phase III trials in earlier stages of NSCLC in potentially curative settings.

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