Treatment effect in both the PD-L1–positive and ITT populations according to on-study chemotherapy partner was an exploratory end point.Īt the American Society of Clinical Oncology 2020 Virtual Scientific Program, PFS results were presented and showed a statistically significant improvement with the addition of pembrolizumab in patients with PD-L1 expression by CPS of 10 or more (HR, 0.65 95% CI, 0.49-0.86 P =. Secondary end points included objective response rate (ORR), duration of response (DOR), and disease control rate (DCR). The dual primary end points of the trial were PFS and overall survival (OS) in patients with PD-L1–positive tumors (CPS ≥10 and CPS ≥1) and in the intention-to-treat (ITT) population. Patients with active central nervous system metastasis, autoimmune disease, or systemic steroid use were not eligible for participation in the study. Stratification factors included the type of on-study chemotherapy, tumor PD-L1 expression at baseline (CPS ≥1 vs <1), and prior treatment with the same class of chemotherapy in the (neo)adjuvant setting. Rugo, MD, a professor in the Department of Medicine, Hematology/Oncology, and director of Breast Oncology and Clinical Trials Education at the University of California San Francisco, Helen Diller Family Comprehensive Cancer Center, said in a virtual presentation of the data. “In subgroup analyses, the improvement in PFS with pembrolizumab plus chemotherapy was observed regardless of chemotherapy partner.”įor the double-blind KEYNOTE-355 trial, patients in the locally recurrent, inoperable, or metastatic setting who had not received prior chemotherapy and were at least 6 months out following curative-intent treatment (N = 847) were randomized 2:1 to receive either pembrolizumab plus chemotherapy (n = 566) or chemotherapy alone (n = 281) until disease progression, unacceptable toxicity, withdrawal of consent, or patient decision. “Pembrolizumab and chemotherapy demonstrated a statistically significant and clinically meaningful improvement in PFS versus chemotherapy alone in the first-line treatment of patients with metastatic TNBC with a tumor PD-L1 CPS of 10 or more,” Hope S. Frontline pembrolizumab (Keytruda) plus chemotherapy for patients with advanced triple-negative breast cancer (TNBC) demonstrated efficacy across key subgroups, including patients with PD-L1 expression by combined positive score (CPS), according to a subgroup analyses of the randomized, phase 3 KEYNOTE-355 trial (NCT02819518) trial presented at the 2020 San Antonio Breast Cancer Symposium.
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