Difference between revisions of "Dalpiciclib (SHR-6390)"
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==Preliminary data== | ==Preliminary data== | ||
===[[Breast cancer, ER-positive]]=== | ===[[Breast cancer, ER-positive]]=== | ||
| − | #'''DAWNA-1:''' Xu B, Zhang Q, Zhang P, Hu X, Li W, Tong Z, Sun T, Teng Y, Wu X, Ouyang Q, Yan X, Cheng J, Liu Q, Feng J, Wang X, Yin Y, Shi Y, Pan Y, Wang Y, Xie W, Yan M, Liu Y, Yan P, Wu F, Zhu X, Zou J; DAWNA-1 Study Consortium. Dalpiciclib or placebo plus fulvestrant in hormone receptor-positive and HER2-negative advanced breast cancer: a randomized, phase 3 trial. Nat Med. 2021 Nov;27(11):1904-1909. Epub 2021 Nov 4. [https://doi.org/10.1038/s41591-021-01562-9 link to original article] [https://pubmed.ncbi.nlm.nih.gov/34737452/ PubMed] [https://clinicaltrials.gov/ | + | #'''DAWNA-1:''' Xu B, Zhang Q, Zhang P, Hu X, Li W, Tong Z, Sun T, Teng Y, Wu X, Ouyang Q, Yan X, Cheng J, Liu Q, Feng J, Wang X, Yin Y, Shi Y, Pan Y, Wang Y, Xie W, Yan M, Liu Y, Yan P, Wu F, Zhu X, Zou J; DAWNA-1 Study Consortium. Dalpiciclib or placebo plus fulvestrant in hormone receptor-positive and HER2-negative advanced breast cancer: a randomized, phase 3 trial. Nat Med. 2021 Nov;27(11):1904-1909. Epub 2021 Nov 4. [https://doi.org/10.1038/s41591-021-01562-9 link to original article] [https://pubmed.ncbi.nlm.nih.gov/34737452/ PubMed] [https://clinicaltrials.gov/study/NCT03927456 Clinical Trial Registry] |
| − | #'''DAWNA-2:''' Zhang P, Zhang Q, Tong Z, Sun T, Li W, Ouyang Q, Hu X, Cheng Y, Yan M, Pan Y, Teng Y, Yan X, Wang Y, Xie W, Zeng X, Wang X, Hu C, Geng C, Zhang H, Li W, Wu X, Zhong J, Xu J, Shi Y, Wei W, Bayaxi N, Zhu X, Xu B. Dalpiciclib plus letrozole or anastrozole versus placebo plus letrozole or anastrozole as first-line treatment in patients with hormone receptor-positive, HER2-negative advanced breast cancer (DAWNA-2): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2023 Jun;24(6):646-657. Epub 2023 May 11. [https://doi.org/10.1016/s1470-2045(23)00172-9 link to original article] [https://pubmed.ncbi.nlm.nih.gov/37182538/ PubMed] [https://clinicaltrials.gov/ | + | #'''DAWNA-2:''' Zhang P, Zhang Q, Tong Z, Sun T, Li W, Ouyang Q, Hu X, Cheng Y, Yan M, Pan Y, Teng Y, Yan X, Wang Y, Xie W, Zeng X, Wang X, Hu C, Geng C, Zhang H, Li W, Wu X, Zhong J, Xu J, Shi Y, Wei W, Bayaxi N, Zhu X, Xu B. Dalpiciclib plus letrozole or anastrozole versus placebo plus letrozole or anastrozole as first-line treatment in patients with hormone receptor-positive, HER2-negative advanced breast cancer (DAWNA-2): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2023 Jun;24(6):646-657. Epub 2023 May 11. [https://doi.org/10.1016/s1470-2045(23)00172-9 link to original article] [https://pubmed.ncbi.nlm.nih.gov/37182538/ PubMed] [https://clinicaltrials.gov/study/NCT03966898 Clinical Trial Registry] |
==Also known as== | ==Also known as== | ||
Revision as of 01:42, 25 June 2023
Mechanism of action
From NCI Drug Dictionary: A cyclin-dependent kinase (CDK) inhibitor with potential antineoplastic activity. Upon administration, dalpiciclib selectively inhibits cyclin-dependent kinase 4 (CDK4) and 6 (CDK6). This inhibits retinoblastoma (Rb) protein phosphorylation early in the G1 phase, which prevents CDK-mediated G1-S phase transition and leads to cell cycle arrest. This suppresses DNA replication and decreases tumor cell proliferation.
Preliminary data
Breast cancer, ER-positive
- DAWNA-1: Xu B, Zhang Q, Zhang P, Hu X, Li W, Tong Z, Sun T, Teng Y, Wu X, Ouyang Q, Yan X, Cheng J, Liu Q, Feng J, Wang X, Yin Y, Shi Y, Pan Y, Wang Y, Xie W, Yan M, Liu Y, Yan P, Wu F, Zhu X, Zou J; DAWNA-1 Study Consortium. Dalpiciclib or placebo plus fulvestrant in hormone receptor-positive and HER2-negative advanced breast cancer: a randomized, phase 3 trial. Nat Med. 2021 Nov;27(11):1904-1909. Epub 2021 Nov 4. link to original article PubMed Clinical Trial Registry
- DAWNA-2: Zhang P, Zhang Q, Tong Z, Sun T, Li W, Ouyang Q, Hu X, Cheng Y, Yan M, Pan Y, Teng Y, Yan X, Wang Y, Xie W, Zeng X, Wang X, Hu C, Geng C, Zhang H, Li W, Wu X, Zhong J, Xu J, Shi Y, Wei W, Bayaxi N, Zhu X, Xu B. Dalpiciclib plus letrozole or anastrozole versus placebo plus letrozole or anastrozole as first-line treatment in patients with hormone receptor-positive, HER2-negative advanced breast cancer (DAWNA-2): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2023 Jun;24(6):646-657. Epub 2023 May 11. link to original article PubMed Clinical Trial Registry
Also known as
- Code name: SHR6390