Caris Molecular Intelligence has the highest clinical utility and is improving patient outcomes in clinical practice
In precision medicine in cancer, clinical utility is defined as the generation of clinical useful and relevant information that can change the course of the disease for a patient, resulting in improved outcomes.1 A recent review article2 has evaluated the clinical utility of Caris Molecular Intelligence (CMI), how it is being used in clinical practice and how it is improving outcomes for cancer patients. The authors recognised that the empiric choice of treatment has a poor response rate for patients who have been previously treated, or for those with rare types of cancer. It has been estimated that the overall response rate for cancer treatment is 35% but that this may decrease to around 6-10% over successive lines of treatment. For these patients, the authors found that CMI can provide “valuable insights … as to which treatments could be beneficial and … which would be best to avoid.”1
The authors detailed the extensive literature review process of CMI to review new predictive biomarker data and to check current associations against new evidence. The authors discussed the SHIVA study,2 which was the first randomised controlled trial to compare molecularly targeted treatments with conventional therapy. They highlighted some dangers in interpreting the results of the SHIVA study, in particular, the risk in extrapolating data from preclinical and animal models into the clinic. In stark contrast to evidence from preclinical or animal models, over 95% of the drug–biomarker associations with CMI are based on level 1 or level 2 evidence. The ~4% of level 3 data includes biomarkers/treatment associations which have been included in the National Comprehensive Cancer Network (NCCN) guidelines.3
The authors stated that proteins, gene expression and mutations, and gene arrangements should be used as predictive biomarkers as they “better reflect the dynamic state of the tumour process.” In addition, they reasoned that using an approach that incorporates multiple technologies is imperative. This underscores the approach that CMI takes with regard to molecular profiling, using a multiplatform CGP+ approach to test tumour DNA, RNA and proteins.
In the review, the clinical evidence supporting the use of CMI was appraised. The authors stated that the “majority of patients profiled are treated in line with the report and a significantly longer overall survival has been observed in many patients.” The review noted that in 10 physician-led studies, 75% of patients were treated in line with the recommendations of the CMI report.
The authors said that the “promising results observed with CMI” was due to the unique approach that Caris takes, which includes “comprehensive, continuous study of the medical literature, highest quality multi-technology platform laboratory assessments and an actionable report that gets reviewed and explained to the treating physicians by an expert in the field.”
They concluded that “with its ‘easy to read’ report, expert help and high clinical utility, this service is readily applicable in each cancer center, whether university, regional hospital and private practice.”2
- Caris Molecular Intelligence has been appraised in a recent review article, in which its quality control, clinical utility, and ability to improve patient outcomes was evaluated.
- CMI’s multiplatform CGP+ approach which incorporates testing of tumour DNA, RNA, and proteins was demonstrated as more effectively reflecting the dynamic nature of tumours than single technology testing (e.g. testing with Next Generation Sequencing alone).
- The high clinical utility of CMI makes it readily applicable to clinical practice, especially for patients with rare, metastatic or advanced cancers who have exhausted standard of care treatment options.
- Janssens J, Gallagher WM, Dean A, Ussia G, Stamp G. Tumor profiling-directed precision cancer therapy – comparison of commercial and academic clinical utility. Int J Surg Surgical Proced. 2017; 2: 123. [PDF]
- Ussia G, Leonard R, Janssens J. Multi-platform tumour profiling delivers the highest clinical utility and improves patient outcomes in today’s routine clinical practice. Int J Surg Surgical Proced. 2016; 1:107. [PDF]
- Le Tourneau C, Delord JP, Gonclaves A, et al. Molecularly targeted therapy based on tumour molecular profiling versus conventional therapy for advanced cancer (SHIVA): A multicentre, openlabel, proof-of-concept, randomised, controlled phase 2 trial. Lancet Oncol. 2015; 16:1324-1334. [Full text]
- Russell K, Shunyakov L, Dicke KA, et al. A practical approach to aid physician interpretation of clinically actionable predictive biomarker results in a multi-platform tumor profiling service. Front Pharmacol. 2014; 5:76. [Full text]
- Russell KJ, Janssens J, Dean A, et al. Comparison of utility cost in three commercially available precision medicine approaches in oncology. Value in Health. 20(9):A590. [PDF]