Mass Spectrometry Classifier for Melanoma IL2 Therapy Prediction
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Solution Overview
Problem
Current methods lack a reliable test to predict which melanoma patients will benefit from high-dose IL2 therapy, leading to inefficiencies and potential harm due to severe side effects, especially with the emergence of new immunotherapy options.
Innovation Solution
A method involving mass spectrometry and a hierarchical combination of classifiers to analyze blood samples from melanoma patients, identifying specific mass spectral features associated with acute response biological functions to predict patient benefit from high-dose IL2 therapy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If high dose IL2 therapy is administered to melanoma patients, then complete response rate is improved (around 10% cure chance), but severe side effects occur (capillary leak syndrome requiring hospitalization)
Solution Approach 1:
The patent applies preliminary action by developing and applying a predictive test using mass spectrometry analysis of blood samples to identify patients likely to respond to IL2 therapy before treatment begins. This allows clinicians to pre-select appropriate candidates, ensuring that only those with high probability of benefit undergo the risky treatment, thereby maintaining the therapeutic benefit while reducing unnecessary exposure to harmful side effects in non-responders
2Duration of action of stationary object
If high dose IL2 therapy is administered, then durable complete response is achieved in some patients, but hospitalization for 1-2 weeks is required with close monitoring
Solution Approach 1:
The predictive test enables preliminary identification of patients who will achieve durable complete responses, allowing clinicians to plan and optimize treatment schedules. By knowing in advance which patients will benefit, the treatment can be more efficiently organized, potentially reducing unnecessary hospitalization time for patients who would not respond anyway
3Productivity
If predictive tests are developed to identify responding patients, then treatment efficiency is improved, but adequate validation has not been achieved yet
Solution Approach 1:
The patent replaces traditional mechanical/validation-intensive testing approaches with mass spectrometry-based molecular profiling. This substitution enables high-throughput, objective, and reproducible prediction of treatment response based on molecular signatures in blood samples, achieving both improved treatment efficiency through better patient selection and enhanced reliability through the objective, quantifiable nature of mass spectrometry data
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
This approach effectively identifies patients likely to benefit from high-dose IL2 therapy, tripling the complete response rate and providing a more attractive treatment option for advanced melanoma patients, while minimizing side effects.
Implementation Method 1
performing mass spectrometry on a blood-based sample of the patient and obtaining mass spectrometry data of the sample
Data Source
AI summary
A method is disclosed for predicting in advance whether a melanoma patient is likely to benefit from high dose IL2 therapy in treatment of the cancer. The method makes use of mass spectrometry data obtained from a blood-based sample of the patient and a computer configured as a classifier and making use of a reference set of mass spectral data obtained from a development set of blood-based samples from other melanoma patients. A variety of classifiers for making this prediction are disclosed, including a classifier developed from a set of blood-based samples obtained from melanoma patients treated with high dose IL2 as well as melanoma patients treated with an anti-PD-1 immunotherapy drug. The classifiers developed from anti-PD-1 and IL2 patient sample cohorts can also be used in combination to guide treatment of a melanoma patient.