Biomarkers /
ABL1 T315I
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Biomarker-Directed Therapies
ABL1 T315I is a predictive biomarker for use of ponatinib, bosutinib, dasatinib, imatinib, and nilotinib in patients.
Of the therapies with ABL1 T315I as a predictive biomarker, 1 is FDA-approved and 5 have NCCN guidelines in at least one clinical setting.
Acute lymphoblastic leukemia and chronic myeloid leukemia have the most therapies targeted against ABL1 T315I or its related pathways [5].
Bosutinib +
Acute Lymphoblastic Leukemia -
Chronic Myeloid Leukemia -
Dasatinib +
Acute Lymphoblastic Leukemia -
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Biomarker Criteria:
Sample must match all of the following:
Sample must match one or more of the following: Sample must match all of the following: |
Predicted Response: Acquired Resistance |
| Clinical Setting(s): Refractory (NCCN) |
Chronic Myeloid Leukemia -
Imatinib +
Acute Lymphoblastic Leukemia -
|
Biomarker Criteria:
Sample must match all of the following:
Sample must match one or more of the following: Sample must match all of the following: |
Predicted Response: Acquired Resistance |
| Clinical Setting(s): Refractory (NCCN) |
Chronic Myeloid Leukemia -
|
Biomarker Criteria:
Sample must match all of the following:
Sample must match one or more of the following: Sample must match all of the following: |
Predicted Response: Acquired Resistance |
| Clinical Setting(s): Refractory (NCCN) |
Nilotinib +
Acute Lymphoblastic Leukemia -
Chronic Myeloid Leukemia -
|
Biomarker Criteria:
Sample must match all of the following:
Sample must match one or more of the following: Sample must match all of the following: |
Predicted Response: Acquired Resistance, Primary Resistance |
| Clinical Setting(s): Refractory (NCCN), Relapse (NCCN) | |
| Note: Applies if the cancer is resistant or intolerant to prior therapy that included imatinib. |
Ponatinib +
Acute Lymphoblastic Leukemia -
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Biomarker Criteria:
Sample must match all of the following:
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Predicted Response: Primary Sensitivity |
| Clinical Setting(s): Maintenance therapy (FDA, NCCN), Refractory (FDA, NCCN), Relapse (FDA, NCCN), Treatment Induction (FDA, NCCN) | |
| Note: Indicated for T315I-positive Ph+ ALL. |
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Biomarker Criteria:
Sample must match one or more of the following:
|
Predicted Response: Primary Sensitivity |
| Clinical Setting(s): Maintenance therapy (FDA, NCCN), Refractory (FDA, NCCN), Relapse (FDA, NCCN), Treatment Induction (FDA, NCCN) | |
| Note: Indicated for T315I-positive Ph+ ALL. |
Chronic Myeloid Leukemia -
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Biomarker Criteria:
Sample must match all of the following:
|
Predicted Response: Primary Sensitivity |
| Clinical Setting(s): Refractory (FDA, NCCN), Relapse (FDA, NCCN) | |
| Note: Indicated for T315I-positive CML (chronic phase, accelerated phase, or blast phase). |
Clinical Trials
ABL1 T315I serves as an inclusion eligibility criterion in 6 clinical trials, of which 5 are open and 1 is closed. Of the trials that contain ABL1 T315I as an inclusion criterion, 2 are phase 1 (1 open), 1 is phase 1/phase 2 (1 open), 2 are phase 2 (2 open), and 1 is phase 3 (1 open).
Trials with ABL1 T315I in the inclusion eligibility criteria most commonly target chronic myeloid leukemia and B-cell acute lymphoblastic leukemia [5].
Hqp1351, cyclophosphamide, ponatinib, allogeneic hematopoietic stem cell transplantation, and avelumab are the most frequent therapies in trials with ABL1 T315I as an inclusion criteria [5].
Significance of ABL1 T315I in Diseases
Chronic Myeloid Leukemia +
ABL1 T315I is an inclusion criterion in 5 clinical trials for chronic myeloid leukemia, of which 4 are open and 1 is closed. Of the trials that contain ABL1 T315I and chronic myeloid leukemia as inclusion criteria, 2 are phase 1 (1 open), 1 is phase 1/phase 2 (1 open), and 2 are phase 2 (2 open) [5].
Ponatinib has evidence of efficacy in patients with ABL1 T315I in chronic myeloid leukemia [5].
Acute Lymphoblastic Leukemia +
ABL1 T315I is an inclusion criterion in 1 clinical trial for acute lymphoblastic leukemia, of which 1 is open and 0 are closed. Of the trial that contains ABL1 T315I and acute lymphoblastic leukemia as inclusion criteria, 1 is phase 1/phase 2 (1 open) [5].
Ponatinib has evidence of efficacy in patients with ABL1 T315I in acute lymphoblastic leukemia [5].
Acute Myeloid Leukemia +
ABL1 T315I is an inclusion criterion in 2 clinical trials for acute myeloid leukemia, of which 2 are open and 0 are closed. Of the trials that contain ABL1 T315I and acute myeloid leukemia as inclusion criteria, 1 is phase 1 (1 open) and 1 is phase 1/phase 2 (1 open) [5].
B-Cell Acute Lymphoblastic Leukemia +
ABL1 T315I is an inclusion criterion in 1 clinical trial for B-cell acute lymphoblastic leukemia, of which 1 is open and 0 are closed. Of the trial that contains ABL1 T315I and B-cell acute lymphoblastic leukemia as inclusion criteria, 1 is phase 3 (1 open) [5].
Chronic Lymphocytic Leukemia +
ABL1 T315I is an inclusion criterion in 1 clinical trial for chronic lymphocytic leukemia, of which 1 is open and 0 are closed. Of the trial that contains ABL1 T315I and chronic lymphocytic leukemia as inclusion criteria, 1 is phase 1 (1 open) [5].
Chronic Myelomonocytic Leukemia +
ABL1 T315I is an inclusion criterion in 1 clinical trial for chronic myelomonocytic leukemia, of which 1 is open and 0 are closed. Of the trial that contains ABL1 T315I and chronic myelomonocytic leukemia as inclusion criteria, 1 is phase 1 (1 open) [5].
Leukemia +
ABL1 T315I is an inclusion criterion in 1 clinical trial for leukemia, of which 1 is open and 0 are closed. Of the trial that contains ABL1 T315I and leukemia as inclusion criteria, 1 is phase 1/phase 2 (1 open) [5].
Lymphoma +
ABL1 T315I is an inclusion criterion in 1 clinical trial for lymphoma, of which 1 is open and 0 are closed. Of the trial that contains ABL1 T315I and lymphoma as inclusion criteria, 1 is phase 1/phase 2 (1 open) [5].
Malignant Solid Tumor +
ABL1 T315I is an inclusion criterion in 1 clinical trial for malignant solid tumor, of which 1 is open and 0 are closed. Of the trial that contains ABL1 T315I and malignant solid tumor as inclusion criteria, 1 is phase 1/phase 2 (1 open) [5].
Multiple Myeloma +
ABL1 T315I is an inclusion criterion in 1 clinical trial for multiple myeloma, of which 1 is open and 0 are closed. Of the trial that contains ABL1 T315I and multiple myeloma as inclusion criteria, 1 is phase 1 (1 open) [5].
Myelodysplastic Syndromes +
ABL1 T315I is an inclusion criterion in 1 clinical trial for myelodysplastic syndromes, of which 1 is open and 0 are closed. Of the trial that contains ABL1 T315I and myelodysplastic syndromes as inclusion criteria, 1 is phase 1 (1 open) [5].
Myelodysplastic/Myeloproliferative Neoplasm +
ABL1 T315I is an inclusion criterion in 1 clinical trial for myelodysplastic/myeloproliferative neoplasm, of which 1 is open and 0 are closed. Of the trial that contains ABL1 T315I and myelodysplastic/myeloproliferative neoplasm as inclusion criteria, 1 is phase 1 (1 open) [5].
Myeloproliferative Neoplasm +
ABL1 T315I is an inclusion criterion in 1 clinical trial for myeloproliferative neoplasm, of which 1 is open and 0 are closed. Of the trial that contains ABL1 T315I and myeloproliferative neoplasm as inclusion criteria, 1 is phase 1 (1 open) [5].
Non-Hodgkin Lymphoma +
ABL1 T315I is an inclusion criterion in 1 clinical trial for non-hodgkin lymphoma, of which 1 is open and 0 are closed. Of the trial that contains ABL1 T315I and non-hodgkin lymphoma as inclusion criteria, 1 is phase 1 (1 open) [5].
References
1. Hart R and Prlic A. Universal Transcript Archive Repository. Version uta_20180821. San Francisco CA: Github;2015. https://github.com/biocommons/uta
2. The UniProt Consortium. UniProt: a worldwide hub of protein knowledge. Nucleic Acids Research. 2019;47:D506-D515.
3. Liu X, Wu C, Li C, and Boerwinkle E. dbNSFP v3.0: A one-stop database of functional predictions and annotations for human nonsynonymous and splice site SNVs. Human Mutation. 2015;37:235-241.
Liu X, Jian X, and Boerwinkle E. dbNSFP: A lightweight database of human nonsynonymous SNPs and their functional predictions. Human Mutation. 2011;32:894-899.
4. The AACR Project GENIE Consortium. AACR Project GENIE: powering precision medicine through an international consortium. Cancer Discovery. 2017;7(8):818-831. Dataset Version 8. This dataset does not represent the totality of the genetic landscape; see paper for more information.
5. All assertions and clinical trial landscape data are curated from primary sources. You can read more about the curation process here.
