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Nivolumab plus low-dose ipilimumab in hypermutated HER2-negative metastatic breast cancer: a phase II trial (NIMBUS)

Author

Listed:
  • Romualdo Barroso-Sousa

    (Hospital Brasília, Rede Américas)

  • Jorge Gomez Tejeda Zanudo

    (Dana-Farber Cancer Institute
    Dana-Farber Brigham Cancer Center
    Harvard Medical School)

  • Tianyu Li

    (Dana-Farber Cancer Institute)

  • Sangeetha M. Reddy

    (University of Texas Southwestern Medical Center)

  • Leisha A. Emens

    (University of Pittsburgh Medical Center)

  • Thomas M. Kuntz

    (Harvard T. H. Chan School of Public Health)

  • Carolina Alves Costa Silva

    (Clinicobiome)

  • Saud H. AlDubayan

    (Dana-Farber Cancer Institute)

  • Hoyin Chu

    (Dana-Farber Cancer Institute)

  • Beth Overmoyer

    (Dana-Farber Cancer Institute
    Dana-Farber Brigham Cancer Center
    Harvard Medical School)

  • Paulina Lange

    (Dana-Farber Cancer Institute)

  • Molly K. DiLullo

    (Dana-Farber Cancer Institute
    Dana-Farber Brigham Cancer Center)

  • Meagan Montesion

    (Foundation Medicine Inc.)

  • Julie Kasparian

    (Dana-Farber Cancer Institute
    Dana-Farber Brigham Cancer Center)

  • Melissa E. Hughes

    (Dana-Farber Cancer Institute
    Dana-Farber Brigham Cancer Center)

  • Victoria Attaya

    (Dana-Farber Cancer Institute
    Dana-Farber Brigham Cancer Center)

  • Ameer Basta

    (Dana-Farber Cancer Institute
    Dana-Farber Brigham Cancer Center)

  • Nancy U. Lin

    (Dana-Farber Cancer Institute
    Dana-Farber Brigham Cancer Center
    Harvard Medical School)

  • Nabihah Tayob

    (Harvard Medical School
    Dana-Farber Cancer Institute)

  • Rinath Jeselsohn

    (Dana-Farber Cancer Institute
    Dana-Farber Brigham Cancer Center
    Harvard Medical School)

  • Elizabeth A. Mittendorf

    (Dana-Farber Brigham Cancer Center
    Harvard Medical School
    Brigham and Women’s Hospital)

  • Sara M. Tolaney

    (Dana-Farber Cancer Institute
    Dana-Farber Brigham Cancer Center
    Harvard Medical School)

Abstract

In the phase II NIMBUS trial, patients with human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer (MBC) and high tumor mutational burden (TMB ≥ 9 mut/Mb) received nivolumab (3 mg/kg biweekly) and low-dose ipilimumab (1 mg/kg every 6 weeks) for 2 years or until progression. The primary endpoint was objective response rate (ORR) per RECIST 1.1 criteria. Among 30 patients enrolled, the median TMB was 10.9 mut/Mb (range: 9–110) and the confirmed objective response rate was 20%. Secondary endpoints included progression-free survival, overall survival, clinical benefit rate, and safety and tolerability, including immune-related adverse events (irAEs). A prespecified correlative outcome was to evaluate the ORR in patients with a TMB ≥ 14 mut/Mb. Patients with TMB ≥ 14 mut/Mb (n = 6) experienced higher response rates (60% vs 12%; p = 0.041) and showed a trend towards improved progression-free survival and overall survival compared to patients with TMB

Suggested Citation

  • Romualdo Barroso-Sousa & Jorge Gomez Tejeda Zanudo & Tianyu Li & Sangeetha M. Reddy & Leisha A. Emens & Thomas M. Kuntz & Carolina Alves Costa Silva & Saud H. AlDubayan & Hoyin Chu & Beth Overmoyer & , 2025. "Nivolumab plus low-dose ipilimumab in hypermutated HER2-negative metastatic breast cancer: a phase II trial (NIMBUS)," Nature Communications, Nature, vol. 16(1), pages 1-13, December.
    • Handle: RePEc:nat:natcom:v:16:y:2025:i:1:d:10.1038_s41467-025-59695-1
    DOI: 10.1038/s41467-025-59695-1
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