Pembrolizumab monotherapy for previously untreated PD-L1-positive, metastatic triple-negative breast cancer: cohort B of the phase 2 KEYNOTE-086 study
Armstrong, Anne C
AffiliationDepartment of Medicine, Perlmutter Cancer Center, New York University School of Medicine, New York, NY, USA
MetadataShow full item record
AbstractBackground: Standard first-line treatment for metastatic triple-negative breast cancer (mTNBC) is chemotherapy. However, outcomes are poor, and new treatment options are needed. In cohort B of the phase 2 KEYNOTE-086 study, we evaluated pembrolizumab as first-line therapy for patients with PD-L1-positive mTNBC. Patients and methods: Eligible patients had centrally confirmed mTNBC, no prior systemic anticancer therapy for metastatic disease, measurable disease at baseline per RECIST v1.1 by central review, no radiographic evidence of central nervous system metastases, and a tumor PD-L1 combined positive score ?1. Patients received pembrolizumab 200?mg intravenously every 3 weeks for up to 2 years. The primary endpoint was safety. Secondary end points included objective response rate (ORR), disease control rate (DCR; percentage of patients with complete or partial response or stable disease for ?24 weeks), duration of response, progression-free survival (PFS) and overall survival (OS). Results: All 84 patients enrolled were women, and 73 (86.9%) received prior (neo)adjuvant therapy. Fifty-three (63.1%) patients had treatment-related adverse events (AEs), including 8 patients (9.5%) with grade 3 severity; no patients experienced grade 4 AEs or died because of treatment-related AEs. Four patients had a complete response and 14 had a partial response, for an ORR of 21.4% (95% CI, 13.9-31.4). Of the 13 patients with stable disease, 2 had stable disease lasting ?24 weeks, for a DCR of 23.8% (95% CI, 15.9-34.0). At data cutoff, 8 of 18 (44.4%) responses were ongoing, and median duration of response was 10.4 months (range, 4.2-19.2+). Median PFS was 2.1 months (95% CI, 2.0-2.2) and median OS was 18.0 months (95% CI, 12.9-23.0). Conclusions: Pembrolizumab monotherapy had a manageable safety profile and showed durable antitumor activity as first-line therapy for patients with PD-L1-positive mTNBC. Clinical trial registration: ClinicalTrials.gov, NCT02447003.
CitationAdams S, Loi S, Toppmeyer D, Cescon DW, De Laurentiis M, Nanda R, et al. Title: Pembrolizumab monotherapy for previously untreated PD-L1-positive, metastatic triple-negative breast cancer: cohort B of the phase 2 KEYNOTE-086 study. Ann Oncol. 2018 Nov 26.
JournalAnnals of Oncology
- Pembrolizumab monotherapy for previously treated metastatic triple-negative breast cancer: cohort A of the phase II KEYNOTE-086 study.
- Authors: Adams S, Schmid P, Rugo HS, Winer EP, Loirat D, Awada A, Cescon DW, Iwata H, Campone M, Nanda R, Hui R, Curigliano G, Toppmeyer D, O'Shaughnessy J, Loi S, Paluch-Shimon S, Tan AR, Card D, Zhao J, Karantza V, Cortés J
- Issue date: 2019 Mar 1
- Pembrolizumab versus investigator-choice chemotherapy for metastatic triple-negative breast cancer (KEYNOTE-119): a randomised, open-label, phase 3 trial.
- Authors: Winer EP, Lipatov O, Im SA, Goncalves A, Muñoz-Couselo E, Lee KS, Schmid P, Tamura K, Testa L, Witzel I, Ohtani S, Turner N, Zambelli S, Harbeck N, Andre F, Dent R, Zhou X, Karantza V, Mejia J, Cortes J, KEYNOTE-119 investigators.
- Issue date: 2021 Apr
- Pembrolizumab plus chemotherapy versus placebo plus chemotherapy for previously untreated locally recurrent inoperable or metastatic triple-negative breast cancer (KEYNOTE-355): a randomised, placebo-controlled, double-blind, phase 3 clinical trial.
- Authors: Cortes J, Cescon DW, Rugo HS, Nowecki Z, Im SA, Yusof MM, Gallardo C, Lipatov O, Barrios CH, Holgado E, Iwata H, Masuda N, Otero MT, Gokmen E, Loi S, Guo Z, Zhao J, Aktan G, Karantza V, Schmid P, KEYNOTE-355 Investigators.
- Issue date: 2020 Dec 5
- Long-term Clinical Outcomes and Biomarker Analyses of Atezolizumab Therapy for Patients With Metastatic Triple-Negative Breast Cancer: A Phase 1 Study.
- Authors: Emens LA, Cruz C, Eder JP, Braiteh F, Chung C, Tolaney SM, Kuter I, Nanda R, Cassier PA, Delord JP, Gordon MS, ElGabry E, Chang CW, Sarkar I, Grossman W, O'Hear C, Fassò M, Molinero L, Schmid P
- Issue date: 2019 Jan 1
- Pembrolizumab in Patients With Extensive-Stage Small-Cell Lung Cancer: Results From the Phase Ib KEYNOTE-028 Study.
- Authors: Ott PA, Elez E, Hiret S, Kim DW, Morosky A, Saraf S, Piperdi B, Mehnert JM
- Issue date: 2017 Dec 1