Entinostat, nivolumab and ipilimumab for women with advanced HER2-negative breast cancer: a phase Ib trial

Evanthia T. Roussos Torres, Won Jin Ho, Ludmila Danilova, Joseph A. Tandurella, James Leatherman, Christine Rafie, Chenguang Wang, Adam Brufsky, Patricia LoRusso, Vincent Chung, Yuan Yuan, Melinda Downs, Ashley O’Connor, Sarah M. Shin, Alexei Hernandez, Elizabeth L. Engle, Richard Piekarz, Howard Streicher, Zahra Talebi, Michelle A. RudekQingfeng Zhu, Robert A. Anders, Ashley Cimino-Mathews, Elana J. Fertig, Elizabeth M. Jaffee, Vered Stearns, Roisin M. Connolly

Research output: Contribution to journalArticlepeer-review


We report the results of 24 women, 50% (N = 12) with hormone receptor-positive breast cancer and 50% (N = 12) with advanced triple-negative breast cancer, treated with entinostat + nivolumab + ipilimumab from the dose escalation (N = 6) and expansion cohort (N = 18) of ETCTN-9844 (NCT02453620). The primary endpoint was safety. Secondary endpoints were overall response rate, clinical benefit rate, progression-free survival and change in tumor CD8:FoxP3 ratio. There were no dose-limiting toxicities. Among evaluable participants (N = 20), the overall response rate was 25% (N = 5), with 40% (N = 4) in triple-negative breast cancer and 10% (N = 1) in hormone receptor-positive breast cancer. The clinical benefit rate was 40% (N = 8), and progression-free survival at 6 months was 50%. Exploratory analyses revealed that changes in myeloid cells may contribute to responses; however, no correlation was noted between changes in CD8:FoxP3 ratio, PD-L1 status and tumor mutational burden and response. These findings support further investigation of this treatment in a phase II trial.

Original languageEnglish (US)
JournalNature Cancer
StateAccepted/In press - 2024

ASJC Scopus subject areas

  • Oncology
  • Cancer Research


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