The DiviTum® TKa Test

Treatment Response Patterns

The only tumor TK activity profile test that risk-stratifies CDK4/6 inhibitor patients into 3 validated profiles1,2*

Unique predictive profiles based on DiviTum® TKa measurements and Treatment Response Patterns

DiviTum TKa Profile 1

Interpretation: DiviTum TKa Profile 1

DiviTum TKa Profile 2

Interpretation: DiviTum TKa Profile 2

DiviTum TKa Profile 3

Interpretation: DiviTum TKa Profile 3

The DiviTum® TKa test has been validated for use only with serum samples from postmenopausal women previously diagnosed with HR+ metastatic breast cancer (mBC).

*In a clinical study of 287 HR+/HER2– mBC patients receiving first-line treatment with ribociclib + letrozole. TKa was analyzed at baseline, C1D15, and C2D1. On-treatment TKa values were used to identify patterns.

References:

1. Malorni L, et al. International Breast Cancer Study Group; Breast International Group and PYTHIA Collaborators. Serum thymidine kinase activity in patients with hormone receptor-positive and HER2-negative metastatic breast cancer treated with palbociclib and fulvestrant. Eur J Cancer. 2022;164:39-51.

2. Malorni L, et al. Serum thymidine kinase activity in patients with HR+/HER2- advanced breast cancer treated with ribociclib plus letrozole: Results from the prospective BioItaLEE trial. Eur J Cancer. 2023; 186: 1–11.

Vigilant Monitoring

Sample Patient Profiles, Assessments, References
Clinical Evidence

Example 1: Patient on CDK4/6 Inhibitor and Endocrine Therapy

TKa = thymidine kinase activity; DuA = DiviTum Units of Activity


*In a study of 287 HR+/HER2– mBC patients receiving first-line therapy with ribociclib + letrozole, almost no patients with this DiviTum TKa. Treatment Response Pattern (n = 62) progressed for 1 year. Median PFS has not yet been reached in this group after 27 months of follow-up.4-5,*

Sample Patient Profiles and Assessments (including References)

Example 2: Patient on CDK4/6 Inhibitor and Endocrine Therapy

TKa = thymidine kinase activity; DuA = DiviTum Units of Activity


*In a study of 287 HR+/HER2– mBC patients receiving first-line therapy with ribociclib + letrozole, median PFS with this DiviTum TKa Treatment Response Pattern (n = 135) was 22 months4-5,*

Sample Patient Profiles and Assessments (including References)

Example 3: Patient on CDK4/6 Inhibitor and Endocrine Therapy

TKa = thymidine kinase activity; DuA = DiviTum Units of Activity


* In a study of 287 HR+/HER2– mBC patients receiving first-line therapy with ribociclib + letrozole, median PFS with this DiviTum TKa Treatment Response Pattern (n = 37) was 10 months.

Sample Patient Profiles and Assessments (including References)

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