Several treatment challenges exist in the management of Ph+ ALL1-5 

Explore considerations for adults newly diagnosed with Ph+ ALL

Challenges exist when treating adult patients newly diagnosed with Ph+ ALL1-5 

Lack of consensus in frontline treatment 

TKIs are part of guideline-recommended treatment regimens1 ; however, none had been FDA-approved.

Aggressive disease with high mutation burden 

• Patients with Ph+ ALL have a high probability of developing mutations in BCR::ABL12,3  
• Mutations lead to resistance and are a primary cause of relapse after 1st- and 2nd-generation TKIs4 

Failure to achieve a complete molecular response

68%.
  • In a meta-analysis, over 2/3 of patients failed to achieve a complete molecular response with 1st- or 2nd-generation TKIs + chemotherapy5*
     
  • Outcomes with 1st- and 2nd-generation TKIs vary by choice of agent and chemotherapy regimen3

*This meta-analysis (25 studies; N=1644) had several limitations: it relied on study-level data with heterogeneous treatment regimens; it included studies based on targeted rather than systemic literature search; results may be limited due to changes in treatment patterns and clinical practice since data were reported; and data for analysis were limited to studies available at the time of analysis. Data should be interpreted with caution.

Complete molecular response was defined as the absence of detectable BCR::ABL1 transcripts with a sensitivity of 0.01%.5

MRD-negative CR is a stringent composite endpoint combining both hematologic and molecular response1,8 

MRD negativity8

Molecular assessment
≤0.01% BCR::ABL1 or undetectable BCR::ABL1 transcripts in cDNA with ≥10,000 ABL1 transcripts

  • In ALL, MRD negativity is recognized as an important prognostic indicator of clinical outcomes across genetic subtypes6
    • Although MRD negativity is a measure of cancer on the molecular level, National Comprehensive Cancer Network® (NCCN®) recommends adequate count recovery per protocol before transitioning to post-remission therapy for patients who achieve it1,7

Complete remission1*

Hematologic assessment
Patient meets all of the following for at least 4 weeks: 
• No circulating blasts and <5% blasts in the bone marrow 
• Normal maturation of all cellular components in the bone marrow 
• No extramedullary disease 
• ANC ≥1000/mcL 
• Platelets ≥100,000/mcL 

*Complete remission is also known as complete response.

Redefining remission in
1st-line Ph+ ALL

PhALLCON efficacy

Comparable safety profile to imatinib in a clinical trial

PhALLCON safety data

ANC=absolute neutrophil count; cDNA=complementary DNA; CR=complete remission; mcL=microliter; MRD=minimal residual disease; NCCN=National Comprehensive Cancer Network; Ph+ ALL=Philadelphia chromosome-positive acute lymphoblastic leukemia; TKI=tyrosine kinase inhibitor.

IMPORTANT SAFETY INFORMATION, INDICATION, AND USAGE

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