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Dalpiciclib Added to First-Line Letrozole or Anastrozole Significantly Prolongs PFS in HR-Positive HER2-Negative Breast Cancer
Findings from the phase 3 DAWNA-2 trial show adding dalpiciclib to first-line letrozole or anastrozole significantly prolonged progression-free survival (PFS) in hormone receptor (HR)-positive, human epidermal growth factor receptor (HER2)-negative advanced breast cancer.
These findings were presented by Binghe Xu, National Cancer Center, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China, at the 2022 European Society for Medical Oncology (ESMO) Congress.
The DAWNA-2 trial randomized 456 patients in a 2:1 ratio to receive dalpiciclib (n = 303) or placebo (n = 153) plus letrozole or anastrozole. The primary end point was investigator-assessed PFS.
The median follow-up was 21.7 for the dalpiciclib group and 21.4 months for the placebo group. Investigator-assessed PFS was 30.6 (95% confidence interval [CI], 30.6 to not reached [NR]) months vs 18.2 (95% CI, 16.5 to 22.5) months, respectively (hazard ratio, 0.51; 95% CI, 0.38 to 0.69; 1-sided P <.0001).
The most frequent grade ≥3 adverse events (AEs) in the dalpiciclib group were neutropenia (85.8%) and leukopenia (66.6%). Serious AEs occurred in 11.9% of patients in the dalpiciclib group and 6.5% in the placebo group. Treatment discontinuation due to AEs were reported in 4% vs 2% of patients, respectively.
“Adding dalpiciclib to letrozole/anastrozole significantly prolonged PFS in HR+/HER2- [advanced breast cancer], with manageable toxicities,” concluded Dr Xu and colleagues.
“Dalpiciclib is the 4th CDK4/6 inhibitor showing survival benefit with letrozole or anastrozole in untreated HR+/HER2- [advanced breast cancer], or with fulvestrant in pretreated HR+/HER2- [advanced breast cancer], in addition to palbociclib, ribociclib and abemaciclib,” they added.
Source:
Xu B, Zhang QY, Zhang P, et al. LBA16 - Dalpiciclib plus letrozole or anastrozole as first-line treatment for HR+/HER2- advanced breast cancer (DAWNA-2): A phase III trial. Presented at: ESMO Congress; September 9-13, 2022. Paris, France and virtual. Abstract LBA16.
