Dr. Rugo on the Results of the KEYNOTE-522 Trial in TNBC

Hope S. Rugo, MD, a professor in the Department of Medicine, Hematology/Oncology, and director, Breast Oncology and Clinical Trials Education, University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center, discusses the results of the phase 3 KEYNOTE-522 trial in triple-negative breast cancer (TNBC).

The field is going to be directed by the results of the MK-3475-522/KEYNOTE-522 trial, which was recently published in the New England Journal of Medicine. In that study, patients with early-stage TNBC received neoadjuvant pembrolizumab (Keytruda) plus paclitaxel and carboplatin followed by doxorubicin or epirubicin and cyclophosphamide. Patients who were randomized to pembrolizumab or placebo continued the chosen agent for 6 months of adjuvant therapy, says Rugo.

Investigators enrolled 1,174 patients to the trial, which was powered to detect event-free survival (EFS). Investigators reported pathologic complete response (pCR) rates in more than 13% of the first 602 patients who enrolled in the trial, says Rugo.

At the 2019 San Antonio Breast Cancer Symposium, the investigators showed more than a 20% improvement in the pCR rate in patients who had node-positive disease. Also, patients benefitted even if they could not complete the full course of treatment.

EFS data are pending, says Rugo. These data are anticipated later this year but are contingent on the number of events that occur.