NEW YORK – ArcherDx and AstraZeneca have formed a strategic collaboration to develop assays to detect minimal residual disease (MRD) in patients with early-stage non-small cell lung cancer, the companies said on Tuesday.
Under the terms of the agreement, Boulder, Colorado-based ArcherDx will perform exome sequencing of resected non-small cell lung cancer patient samples and generate patient-specific, research-use-only circulating tumor DNA assays.
ArcherDx's assay will be used in AstraZeneca's recently launched Phase III MERMAID-1 trial to evaluate the effect of adjuvant treatment with durvalumab (Imfinzi) plus chemotherapy versus chemotherapy alone on disease-free survival. The trial is in patients with completely resected, stage II and III NSCLC who show evidence of MRD suggesting a high risk of relapse.
ArcherDx said that it plans to use these assays to develop companion diagnostics for AstraZeneca's therapies, and together the companies will seek global regulatory approval pending the successful completion of Phase 3 trials. The ongoing development of these assays is informed by the TRACERx study, funded by Cancer Research UK and led by University College London and the Francis Crick Institute.
"MERMAID-1 is a novel randomized trial using ctDNA to identify patients at high risk of recurrence after surgery who may benefit from intervention with immunotherapy," Charles Swanton, professor at UCL and the Francis Crick Institute, chief clinician at CRUK, and coordinating investigator on MERMAID-1, said in a statement. "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 at AstraZeneca, noted in a statement that while detecting and monitoring for MRD "has proven challenging in solid tumors, the MERMAID-1 trial and this partnership stand to break new ground in lung cancer."
The master collaboration agreement also allows for expansion into additional disease indications and therapeutic categories, ArcherDx said. Financial terms of the agreement were not disclosed.