DAWNA-1
The trial that made dalpiciclib the first Chinese CDK4/6 inhibitor approved, more than doubling the time before breast cancer grew when added to fulvestrant.
Overview
361 patients randomised 2:1. Median progression-free survival 15.7 versus 7.2 months (hazard ratio 0.42), published in Nature Medicine 2021, with neutropenia the main toxicity. NMPA approval December 2021; DAWNA-2 (first line with an aromatase inhibitor) followed in 2023. It reproduced the PALOMA-3 and MONALEESA-3 pattern with a domestic, reimbursed drug.
- Median 15.7 vs 7.2 months with Dalpiciclib + fulvestrant compared with Placebo + fulvestrant; about 8.5 months longer for half the group.
- A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
- Put another way, the treated group had about 58 percent lower chance of the event at any given time (hazard ratio 0.42).
- This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
- These results apply to the people the trial enrolled: HR-positive, HER2-negative advanced breast cancer after progression on endocrine therapy, China: dalpiciclib or placebo plus fulvestrant. People in a different situation may not see the same effect.
- The trial selected people by a biomarker (HR-positive); the result should not be assumed for people whose cancer does not have it.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
Pages like this
not linked directly; found by shared links- PersonPiaoyang Sun
Shares Jiangsu Hengrui Pharmaceuticals and the tag china.
- InstitutionInstitute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences
Shares Cancer Hospital, Chinese Academy of Medical Sciences and the tag china.
- TrialCameL
Shares Jiangsu Hengrui Pharmaceuticals and the tag china.
- InstitutionNational Cancer Center of China
Shares Cancer Hospital, Chinese Academy of Medical Sciences and the tag china.
- ProductAdebrelimab
Shares Jiangsu Hengrui Pharmaceuticals and the tag china.
- ProductRivoceranib (apatinib)
Shares Jiangsu Hengrui Pharmaceuticals and the tag china.
- TrialCAPSTONE-1
Shares Jiangsu Hengrui Pharmaceuticals and the tag china.
- ProductTucidinostat (chidamide)
Shares HR-positive / HER2-negative breast cancer and the tag china.