Hengrui Medicine's Blockbuster Phase III Breast Cancer Study Listed in ASCO Oral

The American Society of Clinical Oncology Annual Meeting ( ASCO ) is known as the "Oscar Ceremony" of International Oncology.
This year, due to the impact of the epidemic, it will take the form of a virtual meeting and will be held from June 4 to 8, 2021
.

The researches that are selected for Oral Abstract Session every year are particularly concerned by the industry

(ASCO official website)

DAWNA-1 (NCT03927456) is a multi-center, randomized, controlled, double-blind phase three clinical study, which aims to evaluate dapiciride combined with fulvestrant versus placebo combined with fulvestrant in the treatment of diseases after previous endocrine therapy Efficacy and safety of progressive or recurring HR-positive, HER2-negative locally advanced or advanced metastatic breast cancer
.

The study has reached its main research endpoint, and the results show that dapicillide combined with fulvestrant significantly improved the median PFS compared with placebo combined with fulvestrant, and the safety was controllable

(DAWNA-1 Research Design-ASCO)

According to the sample size ratio of 2:1, the study was randomly assigned to the experimental group (Dapiciride combined with Fulvestrant, Dalp-FULV group) and the control group (Placebo combined with Fulvestrant, PBO-FULV group)
.

The dose of dapicillide is 150 mg once a day for 21 consecutive days, after which the drug is stopped for 7 days (3/1 dosing schedule), 28 days as a treatment cycle; the dose of fulvestrant is 500 mg, intramuscular injection, the first The cycle is administered on the 1st and 15th day, and every treatment cycle thereafter

(Primary study endpoint PFS-ASCO)

The study actually enrolled 361 subjects, 241 in the Dalp-FULV group, and 120 in the PBO-FULV group.
The median follow-up time was 10.
5 months
.

Compared with the PBO-FULV group, the Dalp-FULV group significantly improved the investigator's mPFS (15.

In terms of safety, the most common grade 3 or 4 AE rates in the Dalp-FULV group and PBO-FULV group were 88.
3% and 11.
7%, respectively.
The Dalp-FULV group was significantly higher than the PBO-FULV group; the Dalp-FULV group was the most common Grade 3 or 4 AEs are neutropenia (84.
2%; PBO-FULV: 0%) and leukopenia (62.
1%; PBO-FULV: 0%)
.

The incidence of SAE in the Dalp-FULV group and the PBO-FULV group was 5.

       Dapicillil is a new class 1 chemical drug independently developed by Hengrui Medicine.
It is an oral, highly effective and selective small molecule CDK4/6 inhibitor
.

CDK4/6 kinase and cyclin D1 (Cyclin D) are located downstream of the cell proliferation signal pathway, and CDK4/6 kinase is activated by binding to cyclin D1

       This ASCO conference is the first disclosure of the results of the DAWNA-1 study of Dapicilil Phase III
.

Just last month (May 10), the CDE official website announced that dapicillil had been included in the priority review qualification; in March, it was included in the breakthrough treatment category

       At present, two CDK4/6 inhibitors have been approved for listing in China, including Pfizer's Palbociclib and Eli Lilly's Abemaciclib
.

Piperacillil was approved for marketing in the United States in February 2015.

       Citation

       1.
https://       2.
http://       3.
http://