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Caris Life Sciences launches MI FOLFOXai to determine FOLFOX chemotherapy benefit for CRC patients

Mon, 04/20/2020 - 15:09
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First AI-powered FOLFOX predictor to guide first-line metastatic colorectal cancer treatment

Caris Life Sciences has launched the MI FOLFOXai, the newest addition to the company's suite of comprehensive molecular science offerings. MI FOLFOXai is an Artificial Intelligence (AI)-based predictor of response to FOLFOX chemotherapy in metastatic colorectal cancer that demonstrated approximately 50 percent improvement in overall survival across two independent validation studies. Using Caris Molecular Intelligence tumor profiling results, this AI-powered predictor 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 randomised 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.

"FOLFOX is part of an NCCN Guidelines recommended first-line treatment regimen for the roughly 35,000 patients in the US newly diagnosed with metastatic colorectal cancer each year, and initiating the most appropriate therapy at this stage can be critical to successfully altering the course of disease," said Dr W Michael Korn, Chief Medical Officer of Caris. "Clinical outcomes from MI FOLFOXai validations represent a mean overall survival of nearly 50%, making it imperative to get this information to patients and their physicians as soon as possible."

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.

"We are excited to bring the world's first fully validated AI based treatment algorithm to patients suffering from CRC. MI FOLFOXai will help physicians better determine the relative benefit patients will receive from the FOLFOX chemotherapy regimen and improve clinical outcomes," said David Spetzler, President and Chief Scientific Officer. "Precision medicine powered by AI has enormous potential in cancer profiling, as well as other areas of medicine, and we look forward to continuing to release additional AI-based molecular intelligence products in the near future."