![]() 0.3%, respectively) immune-mediated AEs of any grade occurred in 43.6% vs. Grade ≥3 treatment-related AE rates were 77.1% in the pembro group and 73.3% in the pbo group (death incidence, 0.5% vs. Pembro showed a favorable trend in OS (HR 0.72 ) follow-up is ongoing. The most common EFS event was distant recurrence, in 60 pts (7.7%) in the pembro group vs. 76.8% (95% CI, 72.2-80.7) in the pbo group median was not reached in either group. At the Madata cutoff (median follow-up, 37.8 mo ), 123 pts (15.7%) in the pembro group and 93 pts (23.8%) in the pbo group had an EFS event, defined as disease progression that precluded definitive surgery, a local/distant recurrence, a second primary cancer, or death from any cause (HR 0.63 P=0.0003). Results: 1174 pts were randomized to pembro (n=784) or pbo (n=390). Dual primary endpoints are pCR (ypT0/Tis ypN0) and EFS. T3/T4), and carboplatin schedule (Q3W vs. Pts were stratified by nodal status (+ vs. After definitive surgery, pts received adjuvant pembro or pbo for 9 cycles or until recurrence or unacceptable toxicity. Methods: Pts with previously untreated, non-metastatic, centrally confirmed TNBC (stage T1c N1-2 or T2-4 N0-2 per AJCC) were randomized 2:1 to neoadjuvant pembro 200 mg Q3W or pbo, both given with 4 cycles of paclitaxel + carboplatin, then with 4 cycles of doxorubicin or epirubicin + cyclophosphamide. We present results from a prespecified interim analysis of KEYNOTE-522. In prior interim analyses, pembro + chemo showed a significant improvement in pCR and a favorable trend in EFS. pbo in patients (pts) with early-stage TNBC. placebo (pbo) + chemo followed by adjuvant pembro vs. O’Shaughnessy 18ġCentre for Experimental Cancer Medicine, Barts Cancer Institute, Queen Mary University London, London, UK, 2International Breast Cancer Center, Quirón Group, Madrid and Barcelona, Spain, and Vall d'Hebron Institute of Oncology, Barcelona, Spain, 3National Cancer Center Singapore, Duke–National University of Singapore Medical School, Singapore, 4Yale School of Medicine, Yale Cancer Center, New Haven, CT, USA, 5Breast Oncology, Cedars-Sinai Medical Center, Los Angeles, CA, USA, 6Breast Unit, Kliniken Essen-Mitte, Essen, Germany, 7Department of Oncology-Pathology, Karolinska Institutet and Breast Cancer Centre, Cancer Theme, Karolinska University Hospital, Solna, Sweden, 8Institute of Pathology, Philipps-University Marburg and University Hospital Marburg (UKGM), Marburg, Germany, 9Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea, 10Westmead Breast Cancer Institute, Westmead Hospital and the University of Sydney, Sydney, NSW, Australia, 11Breast Center, LMU University Hospital, Munich, Germany, 12Department of Breast Surgery, Hokkaido Cancer Center, Sapporo, Japan, 13Breast Cancer Center, Helios Klinikum Berlin-Buch, Berlin, Germany, 14University Hospital Erlangen, Comprehensive Cancer Center Erlangen-EMN, Erlangen, Germany, 15Breast Unit, Champalimaud Clinical Center/Champalimaud Foundation, Lisbon, Portugal, 16Biostatistics, Merck & Co., Inc., Kenilworth, NJ, USA, 17Merck Research Laboratories, Merck & Co., Inc., Kenilworth, NJ, USA, 18Baylor University Medical Center, Texas Oncology, US Oncology, Dallas, TX, USAīackground: KEYNOTE-522 (NCT03036488) is a phase III study of neoadjuvant pembrolizumab (pembro) + chemotherapy (chemo) vs.
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