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A retrospective, non-interventional cohort study design using data obtained from the Flatiron Health oncology electronic health record (EHR)-derived de-identified database, was used to address the study objectives.
The overall asciminib cohort included adult patients with Philadelphia positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CML-CP), with or without the T3151 mutation, who initiated asciminib in any line of therapy. The third-line or later (3L+) asciminib cohort included adult patients with Ph+ CML-CP who did not have T315I mutation and initiated asciminib after prior use of at least 2 different tyrosine kinase inhibitors (TKIs) or omacetaxine. The 3L asciminib cohort included the subgroup of the 3L+ asciminib cohort who initiated asciminib after prior use of 2 different TKIs or omacetaxine. The fourth-line or later (4L+) asciminib cohort included the subgroup of the 3L+ asciminib cohort who initiated asciminib after prior use of at least 3 different TKIs or omacetaxine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Overall Asciminib Cohort | Adult patients diagnosed with Ph+ CML-CP, with or without the T3151 mutation, who initiated asciminib in any line of therapy. |
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| Measure | Description | Time Frame |
|---|---|---|
| Age at Index Date | Index date was defined as the date of initiation for asciminib. | Up to 137 months |
| Gender at Index Date | Index date was defined as the date of initiation for asciminib. | Up to 137 months |
| Race at Index Date | Index date was defined as the date of initiation for asciminib. | Up to 137 months |
| Type of Practice at Index Date | Types of practices included: community and academic practices. Index date was defined as the date of initiation for asciminib. | Up to 137 months |
| Eastern Cooperative Oncology Group Performance Score (ECOG-PS) at Index Date | ECOG-PS describes a patient's level of functioning in terms of their ability to care for themself, daily activity, and physical ability (walking, working, etc.). Scores ranged from a lower value of 0 (fully active, able to carry on all pre-disease performance without restriction) up to 4 (completely disabled; cannot carry on any selfcare; totally confined to bed or chair). Index date was defined as the date of initiation for asciminib. | Up to 137 months |
| Number of Patients Categorized by the Five Most Common Baseline Comorbidities | Baseline was defined as the time between the date of initial CML diagnosis up to (and excluding) the date of asciminib initiation (index date). | Baseline |
| Number of Patients Categorized by Last Molecular Response (MR) Achieved Within 3-months Prior to Index Date |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Categorized by Best Molecular Response (MR) Achieved Within 12-months Post-index Date | MR categories included:
Index date was defined as the date of initiation for asciminib. |
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Inclusion criteria:
Exclusion criteria:
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This was a retrospective, noninterventional cohort study.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Pharmaceuticals | East Hanover | New Jersey | 07936 | United States |
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| ID | Term |
|---|---|
| D015466 | Leukemia, Myeloid, Chronic-Phase |
| ID | Term |
|---|---|
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
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MR categories included:
Index date was defined as the date of initiation for asciminib. |
| Up to 3 months pre-index date |
| Median Duration of Observation from Index Date to the end of the Study Period | The study period was defined as the time between the index date (inclusive) until the earliest of stem-cell transplant (SCT), death, loss-to-follow-up (i.e., last activity in the electronic medical record data), or end of data availability (i.e., 30 November 2022). The index date was the date of initiation for asciminib. | Up to 13 months |
| Number of Patients by First Observed Line of Therapy with Asciminib at Index Date | Index date was defined as the date of initiation for asciminib. | Up to 137 months |
| Number of Patients Categorized by Dosage of Asciminib at Index Date | Index date was defined as the date of initiation for asciminib. | Up to 137 months |
| Number of Patients by Status at End of First Observed Line of Therapy with Asciminib | Status:
| From date of asciminib initiation to end of study period, up to 13 months |
| Number of Patients by Type of First Tyrosine Kinase Inhibitor (TKI) Received Before Asciminib Initiation | Up to 137 months |
| Number of Patients by Type of TKI Received Immediately Before Asciminib Initiation | Up to 137 months |
| Number of Patients by Type of TKI Received Anytime Before Asciminib Initiation | Up to 137 months |
| Number of Patients by Most Common Treatment Sequence | From initial CML diagnosis until the end of study period, up to 143 months |
| Asciminib Treatment Persistence Rate Post-Index Date | Index date was defined as the date of initiation for asciminib. | Week 12, week 24 post-index date |
| 12 months post-index date |
| Number of Patients With one or More MR Test Post-index Date who Achieved or Maintained MR3/Major MR (MMR) | MR3/MMR was defined as BCR::ABL1 less than or equal to 0.1%. Index date was defined as the date of initiation for asciminib. | Week 12, week 24 post-index date |
| Number of Patients With one or More MR Test Post-index Date who Achieved or Maintained MR2 | MR2 was defined as BCR::ABL1 less than or equal to 1%. Index date was defined as the date of initiation for asciminib. | Week 12, week 24 post-index date |
| Number of Patients Without MR3/MMR Prior to Asciminib Initiation who Achieved MR3/MMR Post-index Date | MR3/MMR was defined as BCR::ABL1 less than or equal to 0.1%. Index date was defined as the date of initiation for asciminib. | Week 12, week 24 post-index date |
| Median Time to MR3/MMR Post-index Date Among Patients Without MR3/MMR Prior to Asciminib Initiation | MR3/MMR was defined as BCR::ABL1 less than or equal to 0.1%. Index date was defined as the date of initiation for asciminib. | From index date until the end of study period, up to 13 months |
| Number of Patients Without MR2 Prior to Asciminib Initiation who Achieved MR2 Post-index Date | MR2 was defined as BCR::ABL1 less than or equal to 1%. Index date was defined as the date of initiation for asciminib. | Week 12, week 24 post-index date |
| Median Time to MR2 Post-index Date Among Patients Without MR2 Prior to Asciminib Initiation | MR3/MMR was defined as BCR::ABL1 less than or equal to 1%. Index date was defined as the date of initiation for asciminib. | From index date until the end of study period, up to 13 months |
| D009369 | Neoplasms |
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |