Geburtshilfe Frauenheilkd 2018; 78(10): 275-276
DOI: 10.1055/s-0038-1671599
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Ribociclib (RIB) + fulvestrant (FUL) in postmenopausal women with hormone receptor-positive (HR+), HER2-negative (HER2-) advanced breast cancer (ABC): Results from MONALEESA-3

DJ Slamon
1  UCLA Medical Center, Santa Monica, Vereinigte Staaten von Amerika
,
P Neven
2  Universitair Ziekenhuis, Leuven, Belgien
,
S Chia
3  BC Cancer Agency, Vancouver, Kanada
,
SA Im
4  Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea, Republik
,
PA Fasching
5  University Hospital Erlangen, Comprehensive Cancer Center Erlangen-EMN, Erlangen, Deutschland
,
M De Laurentiis
6  National Cancer Institute „Fondazione G. Pascale”, Naples, Italien
,
K Petrakova
7  Masaryk Memorial Cancer Institute, Brno, Tschechische Republik
,
GV Bianchi
8  Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italien
,
FJ Esteva
9  NYU Langone Medical Center, New York, Vereinigte Staaten von Amerika
,
M Martin
10  Hospital General Universitario Gregorio Marañón, Madrid, Spanien
,
X Pivot
11  CHRU de Besançon – IRFC, Besançon, Frankreich
,
G Vidam
12  Novartis Pharmaceuticals Corporation, East Hanover, Vereinigte Staaten von Amerika
,
Y Wang
13  Novartis Pharma AG, Basel, Schweiz
,
K Rodriguez Lorenc
12  Novartis Pharmaceuticals Corporation, East Hanover, Vereinigte Staaten von Amerika
,
M Miller
12  Novartis Pharmaceuticals Corporation, East Hanover, Vereinigte Staaten von Amerika
,
T Taran
12  Novartis Pharmaceuticals Corporation, East Hanover, Vereinigte Staaten von Amerika
,
G Jerusalem
14  CHU Liege and Liege University, Liège, Belgien
› Author Affiliations
Further Information

Publication History

Publication Date:
20 September 2018 (online)

 

Background:

MONALEESA-3 (NCT02422615) is a Phase 3 study of RIB + FUL in pts with HR+, HER2– ABC who received no or up to 1 line of prior endocrine therapy (ET) for ABC.

Methods:

Postmenopausal women with HR+, HER2– ABC (N = 726) were randomized 2:1 to RIB (600 mg/day; 3-weeks-on/1-week-off) + FUL (500 mg) or placebo (PBO) + FUL. Primary objective: investigator-assessed PFS. Secondary objectives included overall survival, overall response rate (ORR), clinical benefit rate (CBR), and safety.

Results:

Median duration from randomization to data cut-off: 20.4 months. The primary objective was met: PFS was significantly improved in the RIB arm vs. the PBO arm (hazard ratio: 0.593; 95% confidence interval [CI]: 0.480 – 0.732; p = 4.10 × 10-7). Consistent PFS benefit was observed in pts with no (hazard ratio: 0.577; 95% CI: 0.415 – 0.802) and up to 1 line of prior ET for ABC (hazard ratio: 0.565; 95% CI: 0.428 – 0.744). In pts with measurable disease at baseline, ORR was 41% vs. 29% (RIB vs. PBO arm; p = 0.003); CBR was 69% vs. 60% (p = 0.015). In the RIB vs. PBO arms, Grade (G) 3/4 neutropenia occurred in 47%/7% vs. 0%/0% of pts, G3/4 increased ALT 7%/2% vs. < 1%/0%, and G3/4 increased AST in 5%/1% vs. 1%/0%.

Conclusions:

RIB + FUL vs. PBO + FUL significantly prolonged PFS and demonstrated a manageable safety profile in postmenopausal pts with HR+, HER2- ABC who received no or up to 1 line of prior ET for advanced disease. RIB + FUL may, therefore, be a treatment option for this pt population.