Scoring methods for anti-pd therapy eligibility and compositions for performing same
AssigneesAgilent Technologies, Inc., Merck Sharp & Dohme Corp.
InventorsKarina Kulangara, Nancy Zhang, David Stanforth, Greg Angelides, Stephanie Waldroup
Life of this patent
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Abstract
Aspects of the present disclosure provide methods for determining the eligibility of a subject having a malignancy for treatment with an anti-PD therapeutic agent based on a Combined Positive Score (CPS) for a tumor tissue sample from the subject. Compositions and kits or performing the disclosed methods are also provided.
Claims20
A method for determining the eligibility of a subject having a malignancy for treatment with an anti-PD therapeutic agent, the method comprising:
- determining the number of viable PD-L1 positive tumor cells, the number of viable PD-L1 negative tumor cells, and the number of viable PD-L1 positive mononuclear inflammatory cells (MIC) in a tumor tissue sample from a subject having a malignancy;
- calculating a combined positive score (CPS) for the tumor tissue sample using the formula:
- C
-
-
- P
-
-
- S
- =
- PD
-
- -
-
- L
-
- 1
-
-
- positive
-
-
- tumor
-
-
- cells
- +
- PD
-
- -
-
- L
-
- 1
-
-
- positive
-
-
- MIC
- PD
-
- -
-
- L
-
- 1
-
-
- positive
-
-
- tumor
-
-
- cells
- +
- PD
-
- -
-
- L
-
- 1
-
-
- negative
-
-
- tumor
-
-
- cells
- ×
- 100
-
- %
- wherein the subject is eligible for treatment with an anti-PD therapeutic agent when the CPS is above a threshold.
A kit for determining the eligibility of a subject having a malignancy for treatment with an anti-PD therapeutic agent, comprising:
- a detectable PD-L1 specific binding agent;
- and
- instructions for calculating a combined positive score (CPS).
Dependencies are inferred from the claim text.