Unmet Needs in CML
CHALLENGES FOR RESISTANT AND INTOLERANT PATIENTS
Patients with suboptimal responses and/or intolerance to 2 or more TKIs may need a different approach1-6
More than half of patients with CML on their 3rd TKI were intolerant to prior TKIs7
intolerant to a previous TKI7
These data are specific to a Phase 2 study in which 60 patients with CML-CP or CML-AP were treated with 2 prior TKIs.7
Addressing intolerance after multiple TKIs remains an urgent need.7,8
Cycling through ATP-competitive TKIs may lead to low response rates2,9,10
In a Phase 1/2 study of 118 patients receiving bosutinib who had been previously treated with ≥2 TKIs11:
24% of patients achieved CCyrR11,*
15% of patients achieved MMR11,*
Finding the right treatment for these patients is key to meeting critical milestones.1-6
PATIENT SCENARIOS AFTER 2 TKIs
Consider a different Ph+ CML-CP treatment for:
Patient portrayal.
Patients who have moderate and persistent† adverse reactions
These patients can face challenges that can lead to dosing changes or interruptions, as well as treatment discontinuation.11
Patient portrayal.
Patients with suboptimal responses on their 2nd TKI
These patients may have never responded, started losing the responses they initially achieved, or their responses have plateaued.2,9,10
Until 2021, there was no treatment with superior response rates vs a 2nd-generation TKI in a Phase 3 trial.1,6,13-19
AP, accelerated phase; ATP, adenosine 5’-triphosphate; CCyR, complete cytogenetic response; MMR, major molecular response; NCCN, National Comprehensive Cancer Network.
*Data based on a multicenter, open-label Phase 1/2 study of best cumulative response rates to bosutinib (starting dose: 500 mg/day) in patients previously treated with and who developed resistance to a 1st-line TKI. Additionally, these patients were resistant to or intolerant to a ≥2nd-line TKI. One patient in the study had CML-AP. The median follow-up was 28.5 months. In this study, CCyR was defined as 0% Ph+ metaphases, and MMR was defined as ≥3-log reduction from standardized baseline in ratio of BCR::ABL to ABL transcripts.11
†Grade 2 toxicity that is unresponsive to optimal management, including dose adjustments.