Key clinical point: Dalpiciclib plus fulvestrant prolonged progression-free survival (PFS) compared with placebo+fulvestrant in patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer who progressed during or after endocrine therapy.
Major finding: Patients receiving dalpiciclib+fulvestrant showed significantly prolonged investigator-assessed progression-free survival than those who received placebo+fulvestrant (median, 15.7 months vs 7.2 months; hazard ratio, 0.42; P < .0001). Serious adverse events were reported by 5.8% vs 6.7% of patients recieving dalpiciclib+fulvestrant vs placebo+fulvestrant.
Study details: Findings are interim results from phase 3 DAWNA-1 trial, including 361 patients with HR-positive, HER2-negative locally advanced breast cancer who progressed on endocrine therapy and were randomly assigned to dalpiciclib+fulvestrant or placebo+fulvestrant.
Disclosures: This study was funded by Jiangsu Hengrui Pharmaceuticals. The authors reported receiving research grants, advisory fees from Hengrui and other sources. Four authors declared being employees of Hengrui.
Source: Xu B et al. Nat Med. 2021 Nov 4. doi: 10.1038/s41591-021-01562-9.