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    Pembrolizumab monotherapy for previously untreated PD-L1-positive, metastatic triple-negative breast cancer: cohort B of the phase 2 KEYNOTE-086 study

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    Authors
    Adams, S
    Loi, S
    Toppmeyer, D
    Cescon, DW
    De, LM
    Nanda, R
    Winer, EP
    Mukai, H
    Tamura, K
    Armstrong, Anne C
    Liu, MC
    Iwata, H
    Ryvo, L
    Wimberger, P
    Rugo, HS
    Tan, AR
    Jia, L
    Ding, Y
    Karantza, V
    Schmid, P
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    Affiliation
    Department of Medicine, Perlmutter Cancer Center, New York University School of Medicine, New York, NY, USA
    Issue Date
    2018
    
    Metadata
    Show full item record
    Abstract
    Background: 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.
    Citation
    Adams 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.
    Journal
    Annals of Oncology
    URI
    http://hdl.handle.net/10541/621399
    DOI
    10.1093/annonc/mdy518
    PubMed ID
    30475947
    Additional Links
    https://dx.doi.org/10.1093/annonc/mdy518
    Type
    Article
    Language
    en
    ae974a485f413a2113503eed53cd6c53
    10.1093/annonc/mdy518
    Scopus Count
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