biostudies-literatureUnknown30(11)Agarwal NEli Lilly and Company (Lilly)Eli Lilly and Company<h4>Purpose</h4>Cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitors radically changed the treatment paradigm for breast cancer. Similar to estrogen receptor in breast cancer, androgen receptor signaling activates cyclin D-CDK4/6, driving proliferation and resistance to hormonal manipulation in prostate cancer. This study was designed to detect signals of clinical activity for abemaciclib in treatment-refractory metastatic castration-resistant prostate cancer (mCRPC).<h4>Patients and methods</h4>Eligible patients had progressive mCRPC, measurable disease, and previously received ≥1 novel hormonal agent(s) and 2 lines of taxane chemotherapy. Abemaciclib 200 mg twice daily was administered on a continuous dosing schedule. Primary endpoint was objective response rate (ORR) without concurrent bClinical cancer research : an official journal of the American Association for Cancer Research2377-2383https://www.ebi.ac.uk/biostudies/studies/S-EPMC11145166biostudies-literatureA Signal-Finding Study of Abemaciclib in Heavily Pretreated Patients with Metastatic Castration-Resistant Prostate Cancer: Results from CYCLONE 1.PMC11145166Agarwal NGravis GRey PMSchweizer MTColomba EArranz Arija JAGonzalez MAppiah AKAlonso-Gordoa TFlechon ANacerddine KOudard SHaddad NJohnston ECastellano DGallardo EMourey LBalar APiulats JMfalseA Signal-Finding Study of Abemaciclib in Heavily Pretreated Patients with Metastatic Castration-Resistant Prostate Cancer: Results from CYCLONE 1.<h4>Purpose</h4>Cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitors radically changed the treatment paradigm for breast cancer. Similar to estrogen receptor in breast cancer, androgen receptor signaling activates cyclin D-CDK4/6, driving proliferation and resistance to hormonal manipulation in prostate cancer. This study was designed to detect signals of clinical activity for abemaciclib in treatment-refractory metastatic castration-resistant prostate cancer (mCRPC).<h4>Patients and methods</h4>Eligible patients had progressive mCRPC, measurable disease, and previously received ≥1 novel hormonal agent(s) and 2 lines of taxane chemotherapy. Abemaciclib 200 mg twice daily was administered on a continuous dosing schedule. Primary endpoint was objective response rate (ORR) without concurrent b2024-01-01T00:00:00Z2024 Jun2026-06-03T04:21:34.025Z2026-04-24T03:09:58.24ZS-EPMC111451663851211710.1158/1078-0432.CCR-23-3436