IMMUNOLOGICAL MARKERS FOR ADJUVANT THERAPY IN MELANOMA
The present invention concerns embodiments for determining whether an individual in need of immunotherapy will be responsive to the immunotherapy. Determination of one or more SNPs in particular genes is predictive of responsiveness to immunotherapy, particularly in individuals that have melanoma, for example. In certain embodiments, the SNPs are in ITGB2, SP1 1O, ILIB, IL23R, SLC11A1, IL12B, CCR5, TNF, ILIO, CXCL12, BTNL2, ANKRD20A4, CD 14, P2X7, IL8, TLR2, and/or CD209.
1 . A method of determining whether or not an individual will be responsive to immunotherapy, comprising the step of providing a representative value for a specific allelic configuration in one or more single nucleotide polymorphisms (SNPs) in nucleic acid from a sample from the individual and comparing the representative value to a pre-determined threshold value, wherein when the representative value is greater than the threshold, the individual will respond to the immunotherapy, wherein the SNPs are located in ITGB2, SP110, IL1B, IL23R, SLC11A1, IL12B, CCR5, TNF, IL10, CXCL12, BTNL2, ANKRD20A4, CD14, P2X7, IL8, TLR2, and/or CD209.
2 . The method of claim 1 , wherein the SNP is at least one of the SNPs identified in Table 1.
3 . The method of claim 1 , wherein the SNPs are all of the SNPs identified in Table 1.
4 . The method of claim 1 , wherein the immunotherapy comprises Bacillus Calmette-Guérin (BCG), cytokine therapy, monoclonal antibody-based therapy, anti-PD1/PD1-ligand therapy, MAPKinase inhibitor, anti-toll like receptor (TLR) therapy, dabrafenib, tumor-infiltrating lymphocyte therapies, or a combination thereof.
5 . The method of claim 4 , wherein the cytokine therapy comprises interferon (IFN), interleukin-2 (IL-2) therapy, or a combination thereof.
6 . The method of claim 4 , wherein the monoclonal antibody-based treatment comprises ipilimumab, vemurafenib, sorafenib, or a combination thereof.
7 . The method of claim 1 , wherein the individual has melanoma.
8 . The method of claim 1 , wherein the individual has received or is receiving a melanoma therapy.
9 . The method of claim 8 , wherein the melanoma therapy comprises surgery, radiation, chemotherapy, or immunotherapy.
10 . The method of claim 1 , wherein the individual is human.
11 . The method of claim 1 , wherein the sample is tissue biopsy, serum, or blood.
12 . The method of claim 1 , further comprising the step of obtaining the sample from the individual.
13 . The method of claim 1 , wherein DNA is isolated from the sample.
14 . The method of claim 1 , wherein RNA is isolated from the sample.
15 . The method of claim 1 , wherein at least part of the nucleic acid from the sample is amplified prior to detection.
16 . A method of treating an individual for cancer, wherein the cancer treatment comprises immunotherapy, comprising the step of providing an effective amount of the immunotherapy to the individual when a representative value for a specific allelic configuration in one or more single nucleotide polymorphisms (SNPs) in nucleic acid from a sample from the individual is greater than a pre-determined threshold value, wherein the SNPs are in genes selected from the group consisting of ITGB2, SP110, IL1B, IL23R, SLC11A1, IL12B, CCR5, TNF, IL10, CXCL12, BTNL2, ANKRD20A4, CD14, P2X7, IL8, TLR2, CD209; and a combination thereof.
17 . The method of claim 16 , wherein the SNP is at least one of the SNPs identified in Table 1.
18 . The method of claim 16 , wherein the SNPs are all of the SNPs identified in Table 1.
19 . The method of claim 16 , wherein the immunotherapy comprises Bacillus Calmette-Guérin (BCG), cytokine therapy, monoclonal antibody-based therapy, anti-PD1/PD1-ligand therapy, MAPKinase inhibitor, anti-TLR therapy, or a combination thereof.
20 . The method of claim 16 , further comprising the step of providing an anti-cancer agent to the individual.
21 . The method of claim 16 , further comprising the step of identifying an individual in need of the cancer treatment.
22 . The method of claim 16 , wherein the cancer is melanoma.
23 . The method of claim 22 , wherein the individual has had surgical removal of at least part of the melanoma.