Ribociclib plus Fulvestrant Improves Survival in Advanced Breast Cancer

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BREAST CANCER

ADDING RIBOCICLIB TO FULVESTRANT IMPROVES THE SURVIVAL OF ADVANCED BREAST CANCER PATIENTS

Medical writer: Christy HC CHEUNG, BSc | Last updated: 12th January 2020 | In: Breast Cancer, Endocrine Therapy, Oncology

Article Keywords

AstraZeneca, AZ, breast cancer, CDK4/6, Faslodex, fulvestrant, HER2-negative, HR-positive, Kisqali, Novartis, Oncology, ribociclib

In patients with hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer, adding ribociclib to fulvestrant improved the overall survival (OS) by 28% compared to fulvestrant alone, as reported by Slamon et al. (2019) in The New England Journal of Medicine.¹

“The combinations of ribociclib with fulvestrant in the MONALEESA-3 trial and with endocrine therapy, particularly nonsteroidal aromatase inhibitors, in the MONALEESA-7 trial have shown a consistent and meaningful prolongation of survival over placebo.”, first author Prof. DJ Slamon, and colleagues wrote in New England Journal of Medicine.

MONALEESA-3

The phase 3, multicentre, placebo-controlled, MONALEESA-3 trial (NCT02422615) randomised 726 hormone-receptor positive, HER2-negative advanced breast cancer patients in a 2:1 fashion to either receive fulvestrant plus ribociclib (N=484) or fulvestrant plus placebo (N=242).¹ Patients included those who had not yet received treatment for advanced stage disease, those who had received one line of prior treatment, and those who had had a relapse of disease within one year after completing adjuvant or neoadjuvant endocrine therapy. The primary efficacy end point was progression-free survival (PFS) as assessed by the investigator. Overall survival was one of the secondary endpoints. The publication by Slamon et al. reports the data of the second planned interim analysis.

Results

At a median follow-up of 39.4 months there was a significant 28% OS benefit for patients receiving the fulvestrant and ribociclib combination and when compared to fulvestrant and placebo (HR=0.72; 95% CI, 0.57-0.92; p=0.00455). Moreover, subgroup analysis showed a 30% and 27% lower risk-of-death for patients receiving ribociclib as a first or second-line therapy, respectively. In the subgroup of patients receiving first-line therapy, the median PFS was 33.6 months in the ribociclib group vs 19.2 months in the placebo group.

Safety

Adverse events were consistent with those in the primary report, with a higher percentage of neutropenia and leukopenia in patients in the ribociclib group vs placebo group; 57.1% and 15.5% vs 0.8% and 0%, both respectively.

Reference

Slamon DJ et al. N Engl J Med. 2019;doi: 10.1056/NEJMoa1911149.

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