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The article comes: Medical Rubik's Cube Info
Author: Shi Bei
On September 16, Carrick Therapeutics announced the preliminary clinical data of the first in class oral CDK7 inhibitor samuraciclib (CT-7001) at the ESMO 2021 conference
.
CDK7 regulates the transcription of oncogenes, promotes uncontrolled cell cycle progression and resistance to antihormonal therapy
.
Samuraciclib is a first in class oral CDK7 inhibitor under development
.
This phase IIa study aims to evaluate the clinical efficacy and tolerability of samuraciclib combined with fulvestrant in the treatment of hormone receptor positive (HR+), HER2-advanced breast cancer (BC) patients
.
A total of 31 refractory patients were enrolled in the study
.
Of the 24 patients with evaluable efficacy, 17 patients (71%) had tumor shrinkage
.
2 cases (8%) achieved partial remission (PR), and 13 cases (54%) had stable disease (SD)
.
The median progression-free survival (mPFS) of the intention-to-treat group (ITT) was 16.
1 weeks (n=31)
.
It is worth noting that the mPFS of patients without mutations in the TP53 gene was 32.
0 weeks (n=18)
At baseline, patients without liver metastases (n=17) experienced significant prolonged disease control and had not yet reached mPFS
.
At the end of this data, mPFS will be at least 28 weeks
.
The main adverse events were low-grade, reversible and controllable gastrointestinal (GI) events through standard preventive treatment.
No significant neutropenia or bone marrow suppression related to other CDK inhibitors was observed
.
In addition to the above research, Carrick is exploring the therapeutic potential of samuraciclib in triple-negative breast cancer (TNBC), prostate cancer, pancreatic cancer, ovarian cancer and colorectal cancer
.
Samuraciclib has obtained Fast Track designation from the US Food and Drug Administration (FDA) and is used in combination with Fulvestrant to treat CDK4/6 resistant HR+ and HER2-advanced breast cancer, as well as combined chemotherapy to treat locally advanced or metastatic TNBC
.
Note: The original text has been deleted
