Abstract: In alternative embodiments, provided are immunohistochemistry (IHC) methods for determining and scoring reproducibly the extent of nuclear expression of protein Ki-67 (also known as MK167) in a tissue sample. In alternative embodiments, provided are methods for diagnosing, treating or ameliorating or assessing the risk of recurrence for a cancer or a tumor using an IHC method as provided herein. In alternative embodiments, provided are kits comprising components and instructions for practicing methods as provided herein.

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. In certain embodiments, the method includes determining, by immunohistochemistry, the number of PD-L1 positive malignant cells in a tumor tissue section as well as the number of infiltrating non-malignant cells and/or non-malignant cells of the stromal interface area. The infiltrating non-malignant cells and/or non-malignant cells of the stromal interface area are positive for a marker selected from PD-L1, CD8, CD68, and any combination thereof. Compositions and kits or performing the disclosed methods are also provided.

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. In certain embodiments, the method includes determining, by immunohistochemistry, the number of PD-L1 positive malignant cells in a tumor tissue section as well as the number of infiltrating non-malignant cells and/or non-malignant cells of the stromal interface area. The infiltrating non-malignant cells and/or non-malignant cells of the stromal interface area are positive for a marker selected from PD-L1, CD8, CD68, and any combination thereof. Compositions and kits or performing the disclosed methods are also provided.