fulvestrant + samuraciclib

Fulvestrant + samuraciclib is a combination therapy under clinical investigation for the treatment of hormone receptor-positive, HER2-negative advanced or metastatic breast cancer, particularly in patients who have progressed following prior CDK4/6 inhibitor therapy. Fulvestrant is an intramuscularly administered selective estrogen receptor degrader (SERD) that binds to and accelerates degradation of the estrogen receptor, thereby inhibiting estrogen signaling. Samuraciclib (CT7001) is an oral, first-in-class small molecule inhibitor of cyclin-dependent kinase 7 (CDK7), which plays a key role in cell cycle progression and transcriptional regulation. By inhibiting CDK7, samuraciclib disrupts transcription of oncogenic drivers and cell proliferation pathways. The combination aims to overcome resistance mechanisms to endocrine therapy by targeting both the estrogen receptor pathway and cell cycle regulation[1][3][5][6]. Clinical studies have shown encouraging efficacy with tumor shrinkage rates up to 72% in evaluable patients, especially those without TP53 mutations or liver metastases[5][10]. The regimen has received Fast Track designation from the FDA for this indication[1][4].

Brand names

samuraciclib

Other names

fulvestrant and samuraciclibsamuraciclib and fulvestrant