Initial ribociclib plus endocrine therapy for <scp>HR</scp>+/<scp>HER2</scp>− advanced breast cancer in pre‐ and postmenopausal Chinese women: Primary results from a phase 2 randomized study

Abstract Background The MONALEESA‐7 and ‐2 phase 3 randomized trials demonstrated a statistically significant progression‐free survival (PFS) and overall survival (OS) benefit with initial ribociclib + endocrine therapy (ET) versus placebo + ET in pre‐ and postmenopausal patients with hormone receptor–positive (HR+)/human epidermal growth factor receptor 2–negative (HER2−) advanced breast cancer (ABC), respectively. Similar trends were observed in Asian subgroup analyses. This phase 2 bridging study of initial ET + ribociclib enrolled pre‐ and postmenopausal patients with HR+/HER2– ABC from China and was conducted to demonstrate consistency of PFS results in a Chinese population relative to the global MONALEESA‐7 and ‐2 studies. Methods Patients were randomized (1:1) to ET (nonsteroidal aromatase inhibitor + goserelin for premenopausal patients; letrozole for postmenopausal patients) + either ribociclib or placebo. The primary endpoint was investigator‐assessed PFS. Results As of April 25, 2022, the median follow‐up was 34.7 months in both cohorts. In the premenopausal cohort, median PFS was 27.6 months in the ribociclib arm ( n = 79) versus 14.7 months in the placebo arm ( n = 77) (hazard ratio 0.67 [95% CI: 0.45, 1.01]). In the postmenopausal cohort, median PFS was not reached in the ribociclib arm versus 18.5 months in the placebo arm ( n = 77 in each arm) (hazard ratio 0.40 [95% CI: 0.26, 0.62]). Data also suggested improvements in secondary efficacy endpoints, although OS data were not mature. The safety profile in this population was consistent with that in global studies. Conclusions These data demonstrate a favorable benefit–risk profile for ribociclib + ET in Chinese patients.

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Publication Details

Journal
Cancer Medicine
Published
2024-08-01
DOI
https://doi.org/10.1002/cam4.7408
Citations
3
Primary Topic
Advanced Breast Cancer Therapies
Type
article
Field-Weighted Citation Impact
1.26

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article

Initial ribociclib plus endocrine therapy for HR+/HER2− advanced breast cancer in pre‐ and postmenopausal Chinese women: Primary results from a phase 2 randomized study

Jian‐Yun Nie, Shui Wang, Valeria Guarnaccia, Ting Luo et al.
3 citations
Cancer Medicine
Advanced Breast Cancer Therapies
1.26
article

Initial ribociclib plus endocrine therapy for HR+/HER2− advanced breast cancer in pre‐ and postmenopausal Chinese women: Primary results from a phase 2 randomized study

Jian‐Yun Nie, Shui Wang, Valeria Guarnaccia, Ting Luo, Zhenchuan Song, Xiaohua Zeng, Kunwei Shen, Yanqing Bai, Zhongsheng Tong, Wei Li, Chuan Wang, Yu Bi, Huiping Li, Wenhe Zhao, Yueyin Pan, Xu B, Zhi-Min Shao, Wendy Chiang, Li Cai, Qiang Liu, Jin Yang, Haibo Wang
article en
3 citations

Abstract

Abstract Background The MONALEESA‐7 and ‐2 phase 3 randomized trials demonstrated a statistically significant progression‐free survival (PFS) and overall survival (OS) benefit with initial ribociclib + endocrine therapy (ET) versus placebo + ET in pre‐ and postmenopausal patients with hormone receptor–positive (HR+)/human epidermal growth factor receptor 2–negative (HER2−) advanced breast cancer (ABC), respectively. Similar trends were observed in Asian subgroup analyses. This phase 2 bridging study of initial ET + ribociclib enrolled pre‐ and postmenopausal patients with HR+/HER2– ABC from China and was conducted to demonstrate consistency of PFS results in a Chinese population relative to the global MONALEESA‐7 and ‐2 studies. Methods Patients were randomized (1:1) to ET (nonsteroidal aromatase inhibitor + goserelin for premenopausal patients; letrozole for postmenopausal patients) + either ribociclib or placebo. The primary endpoint was investigator‐assessed PFS. Results As of April 25, 2022, the median follow‐up was 34.7 months in both cohorts. In the premenopausal cohort, median PFS was 27.6 months in the ribociclib arm ( n = 79) versus 14.7 months in the placebo arm ( n = 77) (hazard ratio 0.67 [95% CI: 0.45, 1.01]). In the postmenopausal cohort, median PFS was not reached in the ribociclib arm versus 18.5 months in the placebo arm ( n = 77 in each arm) (hazard ratio 0.40 [95% CI: 0.26, 0.62]). Data also suggested improvements in secondary efficacy endpoints, although OS data were not mature. The safety profile in this population was consistent with that in global studies. Conclusions These data demonstrate a favorable benefit–risk profile for ribociclib + ET in Chinese patients.

Cancer MedicineVol. 13(15)
Qingdao University (CN), Hebei Medical University (CN), Novartis (Switzerland) (CH), Fujian Medical University (CN), Harbin Medical University (CN), Sun Yat-sen University (CN), Shanghai Jiao Tong University (CN), Chinese Academy of Medical Sciences & Peking Union Medical College (CN), Peking University (CN), Sichuan University (CN), Ruijin Hospital (CN), Sir Run Run Shaw Hospital (CN), Tianjin Medical University Cancer Institute and Hospital (CN), West China Hospital of Sichuan University (CN), Novartis (China) (CN), Fudan University Shanghai Cancer Center (CN), Peking University Cancer Hospital (CN), Sun Yat-sen Memorial Hospital (CN), Third Affiliated Hospital of Harbin Medical University (CN), Fourth Hospital of Hebei Medical University (CN), Novartis (United States) (US), Anhui Provincial Hospital (CN), First Bethune Hospital of Jilin University (CN), Chongqing Cancer Hospital (CN), Yunnan Provincial Infectious Disease Hospital (CN), Union Hospital (CN), Xi'an Jiaotong University (CN)
Novartis Pharmaceuticals Corporation, Astex Pharmaceuticals, Novartis Institutes for BioMedical Research
Good health and well-being
Openalex Percentile: Top 19%
Advanced Breast Cancer Therapies
1.26
DOIOpen Access PDFOpenAlex
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