Real-World Evaluation of Patient Characteristics and Treatment Patterns Among Patients With CML-CP Treated With Asciminib

NCT06516029 | Completed

• 1 other identifier: CABL001A0US03
• Study Type: observational
• Target: 111
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Myeloid Leukemia, Chronic Phase

Outcome Measures

Primary Outcomes (16)

• 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

  MR categories included: * MR0 (BCR::ABL1 greater than 10%) * MR1 (BCR::ABL1 less than or equal to 10%) * MR2 (BCR::ABL1 less than or equal to 1%) * MR3/Major MR (BCR::ABL1 less than or equal to 0.1%) * MR4 or better (BCR::ABL1 less than or equal to 0.01%) 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: * Continued asciminib treatment (included dose change/held). * Discontinued asciminib treatment.

  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

Secondary Outcomes (7)

• Number of Patients Categorized by Best Molecular Response (MR) Achieved Within 12-months 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)

  Week 12, week 24 post-index date

• Number of Patients With one or More MR Test Post-index Date who Achieved or Maintained MR2

  Week 12, week 24 post-index date

• Number of Patients Without MR3/MMR Prior to Asciminib Initiation who Achieved MR3/MMR Post-index Date

  Week 12, week 24 post-index date

• Median Time to MR3/MMR Post-index Date Among Patients Without MR3/MMR Prior to Asciminib Initiation

  From index date until the end of study period, up to 13 months

Study Arms (1)

Overall Asciminib Cohort

Adult patients diagnosed with Ph+ CML-CP, with or without the T3151 mutation, who initiated asciminib in any line of therapy.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This was a retrospective, noninterventional cohort study.

You may qualify if:

• Patients who initiated asciminib as identified by Flatiron through the Flatiron Health-Novartis Scemblix CML Spotlight database study.
• Patients had at least one diagnosis for CML (International Classification of Diseases, 9th Edition, Clinical Modification \[ICD-9-CM\]: 205.1x; International Classification of Diseases, 10th Edition, Clinical Modification \[ICD-10-CM\]: C92.1x).
• Diagnosed with CP as identified by Flatiron through chart abstraction.
• Had 2 or more documented clinical visits, on different days in the Flatiron data on or after 1 January 2011.
• Had evidence of treatment with asciminib on or after Food and Drug Administration (FDA) approval date (29 October 2021), with data granularity availability at least at the month level for dates of asciminib use.
• Had CML initial diagnosis date on or after 1 January 2011.
• Had 1 or more clinical activity within 6 months prior to asciminib initiation (e.g., medical visit, medication order, lab test, etc.).

You may not qualify if:

• Had stem-cell transplant (SCT) on or prior to asciminib initiation or unknown SCT date.
• Diagnosed with CML in accelerated phase (AP) or blast crisis (BC) before asciminib initiation, as identified by Flatiron through chart abstraction, or had blast greater than 15% or unknown blast result within 60 days prior to asciminib initiation.
• Patients had received a clinical study drug between 15 November 2017 and 4 December 2019 (randomization dates for the ASCEMBL trial).

Sponsors & Collaborators

• Novartis: lead

Study Sites (1)

Novartis Pharmaceuticals

East Hanover, New Jersey, 07936, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Chronic-Phase

Condition Hierarchy (Ancestors)

Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2024
• First Posted: July 23, 2024
• Study Start: April 21, 2023
• Primary Completion: October 2, 2023
• Study Completion: October 2, 2023
• Last Updated: July 23, 2024

Record last verified: 2024-07

Locations

US (1)