Lerociclib, combined with fulvestrant, significantly improves progression-free survival for patients with HR+/HER2− metastatic breast cancer resistant to previous endocrine therapy.
The LEONARDA-1 trial demonstrated improved progression-free survival (PFS) of 11.07 months for lerociclib plus fulvestrant compared to 5.49 months for placebo plus fulvestrant, establishing lerociclib as a viable treatment option for HR+/HER2− patients resistant to endocrine therapy.
The study involved numerous researchers and was funded by Genor Biopharma. Conducted between September 10, 2021, and July 28, 2022, with the data cut-off on December 2, 2022, the research was carried out across 53 centers in China.
This research aims to address the challenge of treatment resistance encountered by patients with advanced breast cancer who have already undergone endocrine therapy. The randomized, double-blind trial enrolled 275 participants assigned to either the treatment or placebo groups, analyzing various endpoints and focusing on PFS assessed by investigators.
Lerociclib showed manageable safety profiles, with lower rates of severe adverse events compared to commonly used treatments.
The addition of lerociclib to fulvestrant significantly reduced the risk of investigator-assessed disease progression/death by 54.9% (HR: 0.451).
The safety profile of lerociclib plus fulvestrant was very favorable and the AEs were well managed.