Sunday, July 28, 2024

NCI Algorithm Promises to Improve Checkpoint Inhibitor Accuracy

One of the dilemmas in checkpoint inhibitor therapy - which can be quite toxic - is predicting who is the best candidate for a strong response.

An NCI Press release highlights a new tool, LORIS, which is an AI-based algorithm and was developed by Ruppin et al. at NCI and Morris et al. at Sloan-Kettering.

See a Linked In blog by Josie Hayes, here.

See the NCI press release here.

See the Nature Cancer article by Chang et al. (June 3) here.

See a summary algorithm online at NCI here.

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Here's the abstract from Nature Cancer (PMID 38831056):

Despite the revolutionary impact of immune checkpoint blockade (ICB) in cancer treatment, accurately predicting patient responses remains challenging. Here, we analyzed a large dataset of 2,881 ICB-treated and 841 non-ICB-treated patients across 18 solid tumor types, encompassing a wide range of clinical, pathologic and genomic features. 

We developed a clinical score called LORIS (logistic regression-based immunotherapy-response score) using a six-feature logistic regression model. LORIS outperforms previous signatures in predicting ICB response and identifying responsive patients even with low tumor mutational burden or programmed cell death 1 ligand 1 expression. LORIS consistently predicts patient objective response and short-term and long-term survival across most cancer types. Moreover, LORIS showcases a near-monotonic relationship with ICB response probability and patient survival, enabling precise patient stratification. 

As an accurate, interpretable method using a few readily measurable features, LORIS may help improve clinical decision-making in precision medicine to maximize patient benefit. LORIS is available as an online tool at https://loris.ccr.cancer.gov/

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See a July 11 article at JAMA FORUM, "Congress must update FDA regulations for Medical AI," by Scott Gottlieb:

https://jamanetwork.com/journals/jama-health-forum/fullarticle/2821274

 

July 11, 2024   Congress Must Update FDA Regulations for Medical AI   -  Scott Gottlieb, MD

 JAMA Health Forum. 2024;5(7):e242691. doi:10.1001/jamahealthforum.2024.2691

When the US Food and Drug Administration (FDA) cleared the Apple Watch in 2018 for use in detecting irregular heart rhythms, many observers were worried that the agency would become mired by its need to dismantle the device to affirm its functionality. Instead, when Apple came to the FDA with a proverbial mountain of data proving its reliability in real-world settings, it bolstered a regulatory concept that was already forming among the agency’s policymakers: taking a firm-based approach to the regulation of lower-risk medical devices. This approach shifted the regulatory focus from scrutinizing the product itself to the results it generated and the developer’s overall approach to confirming the device’s reliability......