Delving into the Latest Updates on Dalpiciclib Isethionate with Synapse

This study is intended to carry out a single arm, prospective, open clinical study, and use Darsilide combined with endocrine therapy, Trastuzumab and Patuzumab to treat early or locally advanced breast cancer of TPBC before surgery. It is intended to further explore the efficacy and safety of the new adjuvant treatment for TPBC patients with step-down therapy.

Start Date01 Jun 2024

Sponsor / Collaborator

Henan Cancer Hospital

NCT06301438 / Not yet recruitingNot ApplicableIIT

Efficacy and Safety of Dalpiciclib in HR+/HER2- Advanced Breast Cancer: a Real-world Study

To evaluate the efficacy and safety of dalpiciclib in patients with HR-positive/HER2-positive advanced breast cancer.

Start Date25 Apr 2024

Sponsor / Collaborator

Renji Hospital

NCT06363734 / RecruitingPhase 2IIT

Osimertinib Plus Dalpiciclib in Patients With EGFR-mutant, CDK4/6 Pathway Aberrant, Advanced Non-small Cell Lung Cancer Following Acquired Resistance on Third-generation EGFR TKI： a Single-arm Phase II Trial

This study is a prospective, single-arm, phase II trial. It is aimed to evaluate the efficacy and safety of the combination of osimertinib and dalpiciclib in patients with EGFR-mutant, CDK4/6 pathway aberrant, advanced NSCLC following acquired resistance to third-generation EGFR TKI.

Start Date09 Apr 2024

Sponsor / Collaborator

Tianjin Medical University Cancer Institute and Hospital

100 Clinical Results associated with Dalpiciclib Isethionate

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100 Translational Medicine associated with Dalpiciclib Isethionate

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100 Patents (Medical) associated with Dalpiciclib Isethionate

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32

Literatures (Medical) associated with Dalpiciclib Isethionate

20 Apr 2024·Expert Review of Pharmacoeconomics & Outcomes Research

Cost-effectiveness comparison of dalpiciclib and abemaciclib combined with an aromatase inhibitor as first-line treatment for HR+/HER2− advanced breast cancer

Article

Author: Meng, Jun ; Ouyang, Lihui ; Li, Anna ; Hong, Juan ; Du, Ning ; Xia, Zhengzheng ; Chen, Tujia ; Zhang, HaiLing ; Zhou, Zhongqi

OBJECTIVESCDK4/6 inhibitors dalpiciclib and abemaciclib have been approved by the Chinese National Medical Products Administration as first-line treatment for postmenopausal females with hormone receptor-positive (HR+) and human epidermal growth factor receptor-2 negative (HER2-) advanced breast cancer (ABC). We aimed to assess the cost-effectiveness of dalpiciclib plus letrozole/anastrozole (non-steroidal aromatase inhibitor [NSAI]) compared with abemaciclib plus NSAI as a first-line treatment for HR+/HER2- ABC in China.METHODSWe constructed a Markov model with three health states to evaluate health and economic outcomes of first-line treatment with dalpiciclib plus NSAI and abemaciclib plus NSAI for HR+/HER2- ABC. Efficacy data was obtained from MONARCH3 and DAWNA-2 trials. Quality-adjusted life-years (QALYs) and incremental cost-effectiveness ratios (ICERs) were calculated.RESULTSCompared with abemaciclib plus NSAI, dalpiciclib plus NSAI resulted in 4.27 additional QALYs, with an ICER of $14827.4/QALY. At a willingness-to-pay threshold of 3 times gross domestic product per capita in China for 2023 ($37721.5/QALY), the cost-effectiveness probability of dalpiciclib plus NSAI was 77.42%.CONCLUSIONSFrom the perspective of Chinese payers, dalpiciclib plus NSAI appears to be a cost-effective strategy compared with abemaciclib plus NSAI for the first-line treatment of patients with HR+/HER2- ABC in China.CLINICAL TRIAL REGISTRATIONMONARCH3, www.clinicaltrials.gov, identifier is NCT02246621 and DAWNA-2, www.clinicaltrials.gov, identifier is NCT03966898.

18 Apr 2024·Current Gene Therapy

WITHDRAWN: SHR6390 Combined with Cabozantinib Inhibits Tumor Progression in the Hepatocellular Carcinoma Mouse Model

Article

Author: Zhang, Yanqiao ; Shan, Dan ; Han, Peng ; Liu, Caiqi ; Zheng, Tongsen ; Zhou, Meng ; Nie, Jianhua ; Shi, Jiaqi ; Wang, Yan ; Lin, Binlin

Since the authors are not responding to the editor’s requests to fulfill the editorial requirement, therefore, the article has been withdrawn. Bentham Science apologizes to the readers of the journal for any inconvenience this may have caused. The Bentham Editorial Policy on Article Withdrawal can be found at https://benthamscience-com.libproxy1.nus.edu.sg/editorial-policies-main.php BENTHAM SCIENCE DISCLAIMER: It is a condition of publication that manuscripts submitted to this journal have not been published and will not be simultaneously submitted or published elsewhere. Furthermore, any data, illustration, structure or table that has been published elsewhere must be reported, and copyright permission for reproduction must be obtained. Plagiarism is strictly forbidden, and by submitting the article for publication the authors agree that the publishers have the legal right to take appropriate action against the authors, if plagiarism or fabricated information is discovered. By submitting a manuscript, the authors agree that the copyright of their article is transferred to the publishers if and when the article is accepted for publication.

01 Mar 2024·MedComm

A pilot trial of neoadjuvant pyrotinib plus trastuzumab, dalpiciclib, and letrozole for triple‐positive breast cancer

Article

Author: Xue, Jinqi ; Xing, Fei ; Zheng, Xinyu ; Zhang, Dianlong ; Zhao, Yafei ; Jiang, Xiaofan ; Huo, Shiwen ; Chen, Guanglei ; Zhang, Keliang ; Zhao, Yi ; Wang, Shuo ; Tu, Wei ; Qiu, Fang ; Shan, Huilian ; Wang, Yimin ; Pang, Zheng ; Liu, Chao ; Tang, Meiyue ; Chen, Zhe-Sheng ; Zhao, Hai ; Niu, Nan ; Liu, Caigang ; Li, Ke ; Xu, Qianshi

AbstractTriple‐positive breast cancer (TPBC) poorly responds to current standard neoadjuvant therapy (trastuzumab plus pertuzumab and chemotherapy). Our previous MUKDEN 01 study showed a promising total pathological complete response (tpCR) rate of 30.4% with neoadjuvant pyrotinib (pan‐human epidermal growth factor receptor tyrosine kinase inhibitor) plus dalpiciclib (cyclin‐dependent kinase 4/6 inhibitor) and letrozole, but the efficacy remains suboptimal. This pilot study (NCT05228951) explored adding trastuzumab to this triplet neoadjuvant regimen in patients with stage II–III TPBC. The primary endpoint was tpCR (ypT0/is, ypN0) rate. Between February 2022 and June 2022, 12 patients were enrolled, and seven (58%; 95% confidence interval [CI], 27.7%–84.8%) patients achieved tpCR. The rate of residual cancer burden (RCB) 0–I was 75% (95% CI, 46.8%–91.1%). The objective response rate (ORR) was 92% (95% CI, 64.6%–98.5%). Mean Ki‐67 level was significantly reduced from 45.0% (95% CI, 19.5%–70.5%) at baseline to 17.2% (95% CI, 0.7%–33.7%) after neoadjuvant therapy (p = 0.03). The most common grade 3 adverse events were diarrhea (four [33%]) and decreased neutrophil count (three [25%]). No grade 4 adverse events or treatment‐related deaths occurred. This four‐drug neoadjuvant regimen shows promising pathological response with an acceptable safety profile in patients with TPBC. A randomized controlled trial (NCT05638594) of this regimen is being conducted.

100 Deals associated with Dalpiciclib Isethionate

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R&D Status

Approved

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Indication	Country/Location	Organization	Date
Hormone receptor positive HER2 negative breast cancer	CN	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	31 Dec 2021

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Castration-sensitive prostate cancer	Phase 3	CN	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	18 Sep 2023
HER2-negative breast cancer	Phase 3	CN	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	30 Apr 2021
Hormone receptor positive breast cancer	Phase 3	CN	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	30 Apr 2021
HER2 Positive Breast Cancer	Phase 3	-	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	15 Jan 2020
Advanced breast cancer	Phase 3	CN	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	13 Jun 2019
HR Positive/HER2 Negative/Node positive breast cancer	Phase 3	CN	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	13 Jun 2019
ER-positive/HER2-positive Breast Cancer	Phase 2	CN	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	12 May 2019
Colorectal Cancer	Phase 1	-	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	30 Jul 2018
Non-Small Cell Lung Cancer	Phase 1	-	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	30 Jul 2018
Hepatocellular Carcinoma	Discovery	-	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	30 Jul 2018

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Clinical Result

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Phase

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ChiCTR2000031608 (ESMO2022) Manual	Phase 2	Mucosal Melanoma of the Head and Neck Second line CDK4 amplification	17	SHR6390 125 mg	(lzqhunspgs) = csfkmutnye vfiforndts (iwnckwyjai ) View more	Positive	10 Sep 2022
NCT05228951 (ASCO2023) Manual	Phase 2	ER positive, PR positive, HER2 positive breast cancer Neoadjuvant ER Positive \| PR Positive \| HER2 Positive	12	pyrotinib+Trastuzumab+Dalpiciclib+Letrozole	vxhmevfvan(sqzjsmowhm) = rfwesfqqla eqrmpxfyhk (xxcffptzvd, 27.7 - 84.8) View more	Positive	26 May 2023
NCT03966898 (DAWNA-2 \| SHR6390-III-302, ESMO2022) Manual	Phase 3	Hormone receptor positive HER2 negative breast cancer First line HR positive \| HER2 negative	456	Dalpiciclib 150 mg+Letrozole 2.5 mg+Anastrozole 1mg	(snvgdcazyh) = ofkwfvclao fffproxssx (fmfbtqpohu, 30.6 - NR) View more	Positive	09 Sep 2022
				Placebo+Letrozole 2.5 mg+Anastrozole 1mg	(snvgdcazyh) = fcpjrhhqio fffproxssx (fmfbtqpohu, 16.5 - 22.5) View more
NCT05132790 (MUKDEN 03, ASCO2023) Manual	Not Applicable	Hormone receptor positive HER2 negative breast cancer Neoadjuvant HR Positive \| HER2 Negative	12	exemestane+SBRT+dalpiciclib	(bdxpxgqzda) = hnwpkvurmo iobgjenjzj (krewuyerbh, 3.5 - 46.0) Met View more	Positive	26 May 2023
NCT04095390 (ASCO2023) Manual	Phase 2	Advanced HER2-Positive Breast Carcinoma HER2 Positive	33	Pyrotinib+Dalpiciclib+Letrozole	(jryxohqbbk) = cfkphqvrwd qoxmqeelbh (felskjoics ) View more	Positive	31 May 2023
				Pyrotinib+Dalpiciclib+Capecitabine	(jryxohqbbk) = rdsdlqzkrj qoxmqeelbh (felskjoics ) View more
NCT03480256 (ASCO2021) Manual	Phase 1	HER2 Positive Solid Tumors \| HER2-positive gastric cancer HER Positive	19	Pyrotinib+SHR6390 (cohort A)	(cwilkvzios) = The most common G3/4 AEs were leukopenia (37%) and anemia (16%). zmzhodosur (ghmfgkggxz ) View more	Positive	28 May 2021
				Pyrotinib+SHR6390 (cohort E)
NCT03481998 (ASCO2022) Manual	Phase 1	Hormone receptor positive HER2 negative breast cancer HR Positive \| HER2 Negative	104	Dalpiciclib+letrozole or anastrozole ( Patients without prior treatment)	(wfqnnddmcw) = ehuxntohzi kcnggffuqf (xckoafclgm ) View more	Positive	02 Jun 2022
				fulvestrant+Dalpiciclib (patients who progressed after ET)	(wfqnnddmcw) = epahrehvuc kcnggffuqf (xckoafclgm ) View more
NCT04293276 (DAP-HER-01 \| HR BLTN 014, ASCO2023) Manual	Phase 2	Advanced HER2-Positive Breast Carcinoma HER2 Positive	40	pyrotinib+dalpiciclib	(dikywpkcou) = axuifjwkjm rfjkdoytxs (ttuosmbgxh, 7.3 - 19.3)	Positive	26 May 2023
				pyrotinib+dalpiciclib (HR-negative patients)	(dikywpkcou) = dsqzzehglj rfjkdoytxs (ttuosmbgxh, 7.3 - NA)
NCT04486911 (MUKDEN 01, ASCO2022) Manual	Phase 2	ER positive, PR positive, HER2 positive breast cancer Neoadjuvant ER Positive \| PR Positive \| HER2 Positive	68	dalpiciclib+letrozole+pyrotinib	(yjbdjsokmz) = gwjylwrnvr gpbbhwacre (otnxnmuddo, 40.9 - 66.9)	Positive	02 Jun 2022
NCT03480256 (ASCO_GI2023) Manual	Phase 1	HER2 Positive Solid Tumors \| HER2-positive gastric cancer HER2-positive	25	pyrotinib+SHR6390	(lbhgatadip) = leukopenia (41.7%), neutropenia (41.7%), anemia (12.5%) and diarrhea (12.5%) bxxtxjyxcx (dwiwknrmpc ) View more	Positive	24 Jan 2023
				pyrotinib+SHR6390 (GC patients)