Senologie - Zeitschrift für Mammadiagnostik und -therapie 2023; 20(02): e5-e6
DOI: 10.1055/s-0043-1769139
Abstracts | DGS

Final Overall Survival Analysis of MONARCH 2: A Phase 3 Trial of Abemaciclib plus Fulvestrant in Patients with Hormone Receptor-positive, Human Epidermal Growth Factor Receptor 2-negative Advanced Breast Cancer

Autoren

  • E.-M. Grischke

    1   Universitäts-Frauenklinik Tübingen, Eberhard-Karls-University, Tübingen, Deutschland

  • A. Llombart-Cussac

    2   Hospital Arnau Vilanova, Valencia, Spanien

  • M. Toi

    3   Graduate School of Medicine, Kyoto University, Kyoto, Japan

  • P. Neven

    4   Universitaire Ziekenhuizen Leuven, Leuven, Belgien

  • J. Sohn

    5   Yonsei Cancer Center, Seoul, Korea, Republik

  • K. Inoue

    6   Saitama Cancer Center, Saitama, Japan

  • X. Pivot

    7   Centre Paul Strauss, INSERM 110, Strasbourg, Frankreich

  • M. Okera

    8   Adelaide Cancer Centre, Adelaide, Australien

  • N. Masuda

    9   Nagoya University Graduate School of Medicine, Nagoya, Japan

  • P. A. Kaufman

    10   University of Vermont Cancer Center, Burlington, Vereinigte Staaten

  • H. Koh

    11   Kaiser Permanente, Bellflower, Vereinigte Staaten

  • P. Conte

    12   DiSCOG, University of Padova and Medical Oncology 2, Istituto Oncologico Veneto, Istituto di Ricovero e Cura a Carattere Scientifico, Padova, Italien

  • V. Andre

    13   Eli Lilly and Company, Indianapolis, Vereinigte Staaten

  • F. Bian

    13   Eli Lilly and Company, Indianapolis, Vereinigte Staaten

  • A. Shahir

    13   Eli Lilly and Company, Indianapolis, Vereinigte Staaten

  • G. van Hal

    13   Eli Lilly and Company, Indianapolis, Vereinigte Staaten

  • G. W. Sledge

    14   Stanford University School of Medicine, Stanford, Vereinigte Staaten
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Objective Abemaciclib (A) is approved for pts with hormone receptor-positive (HR+), HER2− advanced breast cancer (ABC) who progressed on endocrine therapy (ET). MONARCH 2 showed statistical significant PFS and OS benefit and a manageable safety profile for A + fulvestrant (F) over F alone.

We report MONARCH 2 final OS analysis based on 441 OS events including OS, safety, and chemotherapy-free survival (CFS).

Materials and Methods Women (n=669) were randomized 2:1 to receive A (n=446)/placebo (P) (n=223), 150mg twice/day, + F. Randomization was stratified based on metastasis site and prior ET resistance (primary vs secondary). Time-to-event variables were estimated by Kaplan-Meier curves. Hazard ratios (HR) with 95% CI were estimated by Cox proportional hazard model. Data cutoff was March 18, 2022.

Results At median 80 months (m) follow-up time, few pts were still on study drug (11% vs 2%; A vs P). Median OS (45.8m vs 37.2m; A vs P; HR: 0.784; 0.644-0.955) and OS rates (5yr: 41.2% vs 29.2%; 6yr: 34.7% vs 23.7%; A vs P) showed significant benefit for A. Addition of A to F improved CFS rates (4yr: 37% vs 18.6%; 5 yr: 32.4% vs 14.7%). No new safety signals were observed.

Conclusions The results show significant OS and CFS benefits of abemaciclib therapy for ABC are confirmed and maintained and provide assurance of the safety of abemaciclib with longer-term use.

Presented: SABCS 2022.



Publikationsverlauf

Artikel online veröffentlicht:
15. Juni 2023

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