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Association details:
| Biomarker: | ER positive |
|---|---|
| Cancer: | HER2 Negative Breast Cancer |
| Drug: | luvixasertib (CFI-402257) (TTK inhibitor) |
| Direction: | Sensitive |
Evidence:
Title:
Treadwell Therapeutics Announces Fast Track Designation Granted by the FDA to CFI-402257 for the Treatment of ER+/HER2- Breast Cancer
Published date:
01/10/2023
Excerpt:
Treadwell Therapeutics...announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to CFI-402257, a best in class inhibitor of Threonine Tyrosine Kinase (TTK, also known as Mps1), for the treatment of adult patients with ER+/HER2- advanced breast cancer after disease progression on prior CDK4/6 inhibitors and endocrine therapy, both as a monotherapy and in combination with fulvestrant.
Secondary therapy:
fulvestrant
Source:
Title:
P6-10-13 An update to a Phase I trial of CFI-402257, an oral TTK inhibitor, in patients with advanced solid tumors with HER2-negative breast cancer expansion cohorts
Published date:
11/22/2022
Excerpt:
CFI-402257 was dosed once daily on a continuous schedule in 28-day cycles at a starting dose of 5 mg….advanced Her2-negative (ER+ or TNBC) with 1-4 prior lines of chemotherapy for metastatic disease (Cohort B), and ER+/Her2- breast cancer in combination with Fulvestrant...CFI- 402257 is well tolerated as mono and combination with fulvestrant. Efficacy signals are emerging with pts in the combo cohort demonstrating anti-tumor activity.
Source:
Title:
P6-10-13 An update to a Phase I trial of CFI-402257, an oral TTK inhibitor, in patients with advanced solid tumors with HER2-negative breast cancer expansion cohorts
Published date:
11/22/2022
Excerpt:
CFI-402257 was dosed once daily on a continuous schedule in 28-day cycles at a starting dose of 5 mg….advanced Her2-negative (ER+ or TNBC) with 1-4 prior lines of chemotherapy for metastatic disease (Cohort B), and ER+/Her2- breast cancer in combination with Fulvestrant...CFI- 402257 is well tolerated as mono and combination with fulvestrant. Efficacy signals are emerging with pts in the combo cohort demonstrating anti-tumor activity.
Secondary therapy:
fulvestrant
Source:
Title:
Abstract P1-18-17: Phase I study of cfi-402257, an oral ttk inhibitor, in patients with advanced solid tumors with breast cancer expansion cohorts
Published date:
02/15/2022
Excerpt:
PR’s confirmed by the Investigator have been seen to date in 33% of the cohort C subjects (2/6 patients), with an additional two cPR’s seen in the breast cancer population (ER+/HER2-) from the expansion cohorts….CFI-402257 is generally well tolerated and continues to enroll at 168 mg daily with a manageable AE profile and early signs of anti-tumor activity.
DOI:
https://doi.org/10.1158/1538-7445.SABCS21-P1-18-17
