TEST:

DiviTum® TKa test

"Biovica...that seven abstracts based on studies using the blood test DiviTum TKa will be presented at the world's largest breast cancer meeting, San Antonio Breast Cancer Symposium (SABCS) on December 10-13, 2024. Two of the abstracts validates DiviTum TKa in the adjuvant setting (early breast cancer), which will open a new market opportunity for Biovica."

PFS (p=0.003) and OS (p=0.03) differed significantly by logrank test between the four groups: Low-Low-Low (n=14) median PFS and OS not reached; High-Low-Low (n=26) PFS 23.8m (95%CI cant be calculated) and OS 51.8m (95%CI 15.4 to 88.1); High-Low-High (n=24) PFS 17.5m (95%CI 10.2 to 24.8) and OS 34.3m (95%CI15.1 to 53,7) High-High-High PFS 10.3m (95%CI 1.73 to 18.9) and OS 30.3m (95%CI 15.1 to 45.6) In exploratory analyses no significant differences between median TKa at C1D15 or C2D1, or early TKa dynamic patterns were observed between patients treated with palbociclib (n=48) vs ribociclib (n=29), p=0.33 to 1.0. TKa analysis at later time points is ongoing. TKa is an encouraging biomarker for personalized disease monitoring in MBC.

Pts had either de-novo metastatic (53%) or secondary endocrine resistance (44%) and mainly received either ribociclib or abemaciclib in combination with an aromatase inhibitor; only 5% received a CDK4/6i + fulvestrant. ctDNA and sTKa determination give complementary information throughout the pts treatment journey. TC estimation may give useful information on the potential detectability of ctDNA variants in a given sample, potentially informing biomarker search strategies. sTKa is a reliable marker which gives a result in every patient.

MAINTAIN was the first randomized controlled trial to demonstrate a significant progression-free survival (PFS) benefit for HR+, HER2- MBC patients who switched ET (fulvestrant or exemestane) and received the CDK4/6i ribociclib compared to ET plus placebo after progressing on prior CDK4/6i and ET. In the phase II MAINTAIN trial, sTKa was a predictive biomarker for response to switching ET + continuing CDK4/6i in HR+, HER2- MBC pts following progression on CDK4/6i and ET. Low (<250 DuA) C2D1 sTKa levels predicted a positive treatment response, especially among those receiving ribociclib+ET. sTKa dynamics from baseline to C2D1 were prognostic, providing insights into PFS outcomes.

Methods The PACE (NCT03147287) multicenter phase II trial randomized 220 pts with ER+, HER2- MBC who had progressed on at least 6 months (mo) of prior CDK4/6i and aromatase inhibitor (AI) to receive fulvestrant alone (F), F plus palbociclib (F+P), or F+P plus the PD-1 inhibitor avelumab (F+P+A). However, high C2D1 on-treatment TKa was associated with inferior outcomes. Early dynamic changes in TKa levels may allow identification of populations with distinct prognoses, possibly facilitating clinical decisions in this context.

The PENELOPE-B phase III trial explored the addition of one year of palbociclib (P) to endocrine therapy (ET), in HR+, HER2- eBC pts at high risk of relapse after NACT... In a subset of pts from PENELOPE-B, TKa was detectable in all pts at BL and levels were significantly correlated with early disease recurrence where BL TKa values >250 DuA were prognostic for early relapse within the 1st year of adjuvant therapy. CPS-EG scores in contrast were not prognostic. Pts with early disease relapse also had an increase in TKa levels at the time of recurrence.

The CDK4/6 inhibitor abemaciclib is also employed in the adjuvant setting in the treatment of HR+/HER2- tumors at high risk for recurrence... These findings further support the utilization of the DiviTum® TKa assay to monitor response to CDK4/6 inhibitor-based therapy in the standard of care setting. Baseline and the TKa reduction early on treatment could be predictive of duration of PFS. Further study in the high-risk setting is warranted to predict associations with recurrence.

"Biovica...has signed a Master Service Agreement (MSA) with a US-based biotech company...Under the agreement, Biovica will provide TKa testing services utilizing Biovica’s DiviTum® TKa assay and expertise in interpreting TKa measurement dynamics to support drug development and dosage optimization. The agreement will expand DiviTum TKa’s inclusion into a growing list of clinical trials investigating the potential of next generation CDK inhibitor treatment and therefore further increase the likelihood of establishing TKa as a monitoring companion biomarker."

P=N/A, N=50, Recruiting, Yale University

"Biovica...announces that results with DiviTum® TKa from the Spanish GEICAM/2014-12 FLIPPER trial will be presented at the world’s largest cancer conference, the annual ASCO meeting on June 2, 2024 9:00 AM – 12:00 PM CDT. The data supports the use of DiviTum TKa to predict outcome and progression on first line treatment HR+ metastatic breast cancer (MBC) patients providing important clinical information about treatment benefit."

P=N/A, N=100, Recruiting, Mayo Clinic | Not yet recruiting --> Recruiting

P=N/A, N=100, Not yet recruiting, Mayo Clinic