Mass Spectrometry Classifiers for Cancer Immunotherapy Patient Stratification

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Solution Overview

Problem

Current methods for guiding cancer treatment with immunotherapy drugs, such as nivolumab, struggle to accurately identify patients who will benefit from long-term treatment, particularly those with poor prognosis, leading to misclassification and suboptimal treatment outcomes.

Innovation Solution

Development of new classifiers, including New classifier 1 and New classifier 2, which utilize mass spectrometry data from blood samples to hierarchically classify patients, distinguishing between those with durable benefit from immunotherapy and those with poor prognosis, and guiding treatment decisions based on these classifications.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If current classification methods (e.g., BDX008) are used to guide immunotherapy treatment, then treatment guidance is provided for cancer patients, but patients with poor prognosis are misclassified and do not receive appropriate durable benefit

Engineering Contradiction:
Improveclassification accuracyVSAvoidinformation about durable benefit in poor prognosis patients
Core Design Contradiction:
ReliabilityVSLoss of information

Solution Approach 1:

The patent divides the classification process into multiple sequential classifiers (first classifier identifies poor prognosis patients, second classifier identifies durable benefit within that subgroup). This segmentation allows each classifier to focus on specific aspects of patient stratification, improving overall classification accuracy and preventing misclassification of patients with durable benefit.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent adds a new dimension to the classification by introducing a second classification layer specifically for identifying durable benefit within the poor prognosis subgroup. This dimensional extension captures previously lost information about patients who may have favorable outcomes despite overall poor prognosis, thereby resolving the information loss problem.

Inventive Principle:
Principle #17Another dimension (Dimensionality change)

2Adaptability or versatility

If immunotherapy is administered to all cancer patients regardless of prognosis classification, then treatment access is maximized, but patients with poor prognosis and no durable benefit receive suboptimal treatment

Engineering Contradiction:
Improvetreatment guidance precisionVSAvoidclassification system complexity
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The patent segments the patient population into distinct subgroups through sequential classification: first identifying poor prognosis patients, then identifying those with durable benefit within that subgroup. This segmentation enables tailored treatment guidance that adapts to different patient categories, improving treatment precision without requiring a single overly complex classifier.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent performs preliminary classification to identify poor prognosis patients before conducting the second classification for durable benefit. This preliminary action allows the system to efficiently route patients through appropriate classification pathways, providing adaptable treatment guidance while managing system complexity through structured preprocessing.

Inventive Principle:
Principle #10Preliminary action

Data Source

PatentUS20220026416A1Method for identification of cancer patients with durable benefit from immunotehrapy in overall poor prognosis subgroups
Publication Date: 2022.01.27 BIODESIX INC
  • US20220026416A1 patent drawing
  • US20220026416A1 patent drawing
  • US20220026416A1 patent drawing

AI summary

A blood-based sample from a cancer patient is subject to mass spectrometry and the resulting mass spectral data is classified with the aid of a computer to see if the patient is a member of a class of patients having a poor prognosis. If so, the mass spectral data is further classified with the aid of the computer by a second classifier which identifies whether the patient is nevertheless likely to obtain durable benefit from immunotherapy drugs, e.g., immune checkpoint inhibitors, anti-CTLA4 drugs, and high dose interleukin-2.