Abemaciclib plus non-steroidal aromatase inhibitor or fulvestrant in women with HR+/HER2− advanced breast cancer: Final results of the randomized phase III MONARCH plus trial
Abstract. Background:. In the interim analysis of MONARCH plus, adding abemaciclib to endocrine therapy (ET) improved progression-free survival (PFS) and objective response rate (ORR) in predominantly Chinese postmenopausal women with HR+/HER2− advanced breast cancer (ABC). This study presents the...
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| Main Authors: | , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Wolters Kluwer
2025-06-01
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| Series: | Chinese Medical Journal |
| Online Access: | http://journals.lww.com/10.1097/CM9.0000000000003151 |
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| Summary: | Abstract.
Background:. In the interim analysis of MONARCH plus, adding abemaciclib to endocrine therapy (ET) improved progression-free survival (PFS) and objective response rate (ORR) in predominantly Chinese postmenopausal women with HR+/HER2− advanced breast cancer (ABC). This study presents the final pre-planned PFS analysis.
Methods:. In the phase III MONARCH plus study, postmenopausal women in China, India, Brazil, and South Africa with HR+/HER2− ABC without prior systemic therapy in an advanced setting (cohort A) or progression on prior ET (cohort B) were randomized (2:1) to abemaciclib (150 mg twice daily [BID]) or placebo plus: anastrozole (1.0 mg/day) or letrozole (2.5 mg/day) (cohort A) or fulvestrant (500 mg on days 1 and 15 of cycle 1 and then on day 1 of each subsequent cycle) (cohort B). The primary endpoint was PFS of cohort A. Secondary endpoints included cohort B PFS (key secondary endpoint), ORR, overall survival (OS), safety, and health-related quality of life (HRQoL).
Results:. In cohort A (abemaciclib: n = 207; placebo: n = 99), abemaciclib plus a non-steroidal aromatase inhibitor improved median PFS vs. placebo (28.27 months vs. 14.73 months, hazard ratio [HR]: 0.476; 95% confidence interval [95% CI]: 0.348–0.649). In cohort B (abemaciclib: n = 104; placebo: n = 53), abemaciclib plus fulvestrant improved median PFS vs. placebo (11.41 months vs. 5.59 months, HR: 0.480; 95% CI: 0.322–0.715). Abemaciclib numerically improved ORR. Although immature, a trend toward OS benefit with abemaciclib was observed (cohort A: HR: 0.893, 95% CI: 0.553–1.443; cohort B: HR: 0.512, 95% CI: 0.281–0.931). The most frequent grade ≥3 adverse events in the abemaciclib arms were neutropenia, leukopenia, anemia (both cohorts), and lymphocytopenia (cohort B). Abemaciclib did not cause clinically meaningful changes in patient-reported global health, functioning, or most symptoms vs. placebo.
Conclusions:. Abemaciclib plus ET led to improvements in PFS and ORR, a manageable safety profile, and sustained HRQoL, providing clinical benefit without a high toxicity burden or reduced quality of life.
Trial registration:. ClinicalTrials.gov (NCT02763566). |
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| ISSN: | 0366-6999 2542-5641 |