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

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, Paulina Lange, Molly K. DiLullo, Meagan Montesion, Julie Kasparian, Melissa E. Hughes, Victoria Attaya, Ameer Basta, Nancy U. Lin, Nabihah Tayob, Rinath Jeselsohn, Elizabeth A. Mittendorf and Sara M. Tolaney ()
Additional contact information
Romualdo Barroso-Sousa: Hospital Brasília, Rede Américas
Jorge Gomez Tejeda Zanudo: Dana-Farber Cancer Institute
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
Paulina Lange: Dana-Farber Cancer Institute
Molly K. DiLullo: Dana-Farber Cancer Institute
Meagan Montesion: Foundation Medicine Inc.
Julie Kasparian: Dana-Farber Cancer Institute
Melissa E. Hughes: Dana-Farber Cancer Institute
Victoria Attaya: Dana-Farber Cancer Institute
Ameer Basta: Dana-Farber Cancer Institute
Nancy U. Lin: Dana-Farber Cancer Institute
Nabihah Tayob: Harvard Medical School
Rinath Jeselsohn: Dana-Farber Cancer Institute
Elizabeth A. Mittendorf: Dana-Farber Brigham Cancer Center
Sara M. Tolaney: Dana-Farber Cancer Institute

Nature Communications, 2025, vol. 16, issue 1, 1-13

Abstract: 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

Date: 2025
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DOI: 10.1038/s41467-025-59695-1

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