Caris Life Sciences develops AI-powered predictor of chemotherapy sensitivity in MCC

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Caris Life Sciences launched MI FOLFOXai, an artificial intelligence-based predictor of response to FOLFOX chemotherapy in metastatic colorectal cancer that demonstrated approximately 50% improvement in overall survival across two independent validation studies.

The AI-powered predictor is using Caris Molecular Intelligence tumor profiling results, and is intended to gauge a patient’s likelihood of benefit from FOLFOX as a first-line regimen in combination with bevacizumab.

MI FOLFOXai was validated using two independent data sets to compare the increased benefit arm to the decreased benefit arm. The first study was a blinded, prospective analysis from retrospectively tested samples from the randomized phase III TRIBE2 study. This study showed a median overall survival improvement of 6.9 months. The second study involved several hundred cases with real-world evidence that showed a median overall survival increase of 11.8 months.

MI FOLFOXai was developed using a subset of results from the company’s proprietary Caris Molecular Intelligence platform, which includes next generation sequencing for DNA mutations, copy number alterations, insertions/deletions; whole transcriptome sequencing for RNA fusions and variant transcripts; and protein testing via immunochemistry. Machine learning algorithms were then used to create a molecular signature that was validated using the two independent data sets to compare the increased benefit arm to the decreased benefit arm.

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I have spent over 20 years running a tumor imaging metrics core at an academic cancer center. In that time, I have watched clinical trial enrollment concentrate at a relatively small number of flagship academic institutions. Unfortunately, trials do not propagate well to the community sites where most patients prefer to receive care. The explanations usually offered for why this happens have never fully accounted for what I observed.

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