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Clinical Trials: Immunotherapy

Safety and Antitumor Activity of Pembrolizumab in Patients with Estrogen Receptor–Positive/Human Epidermal Growth Factor Receptor 2–Negative Advanced Breast Cancer

Hope S. Rugo, Jean-Pierre Delord, Seock-Ah Im, Patrick A. Ott, Sarina A. Piha-Paul, Philippe L. Bedard, Jasgit Sachdev, Christophe Le Tourneau, Emilie M.J. van Brummelen, Andrea Varga, Roberto Salgado, Sherene Loi, Sanatan Saraf, Dina Pietrangelo, Vassiliki Karantza and Antoinette R. Tan
Hope S. Rugo
1Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, California.
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  • For correspondence: Hope.Rugo@ucsf.edu
Jean-Pierre Delord
2Department of Medical Oncology, Institut Claudius Regaud, Oncolpole-Toulouse, France.
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Seock-Ah Im
3Department of Internal Medicine, Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Republic of Korea.
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  • ORCID record for Seock-Ah Im
Patrick A. Ott
4Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.
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Sarina A. Piha-Paul
5Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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Philippe L. Bedard
6Division of Medical Oncology, UHN Princess Margaret Cancer Centre, Toronto, ON, Canada.
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Jasgit Sachdev
7Breast and GYN Early Trials Program, Scottsdale Healthcare Shea Medical Center, Scottsdale, Arizona.
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Christophe Le Tourneau
8Department of Drug Development and Innovation, Institut Curie, Paris & Saint-Cloud, France, INSERM U900 Research Unit, Saint-Cloud France, and Versailles-Saint-Quentin-en-Yvelines University, Montigny-le-Bretonneux, France.
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Emilie M.J. van Brummelen
9Department of Clinical Pharmacology, Netherlands Cancer Institute, Amsterdam, the Netherlands.
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Andrea Varga
10Drug Development Department, Gustave Roussy, Villejuif, France.
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Roberto Salgado
11Peter MacCallum Cancer Centre, University of Melbourne, Melbourne, Victoria, Australia.
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Sherene Loi
11Peter MacCallum Cancer Centre, University of Melbourne, Melbourne, Victoria, Australia.
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Sanatan Saraf
12Department of Clinical Oncology, Merck & Co., Inc., Kenilworth, New Jersey.
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Dina Pietrangelo
12Department of Clinical Oncology, Merck & Co., Inc., Kenilworth, New Jersey.
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Vassiliki Karantza
12Department of Clinical Oncology, Merck & Co., Inc., Kenilworth, New Jersey.
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Antoinette R. Tan
13Division of Medical Oncology, Department of Medicine, Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey.
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DOI: 10.1158/1078-0432.CCR-17-3452 Published June 2018
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Abstract

Purpose: We investigated the safety and antitumor activity of the anti–programmed death 1 monoclonal antibody pembrolizumab in patients with estrogen receptor–positive (ER+)/human epidermal growth factor receptor 2–negative (HER2−) advanced breast cancer with programmed death ligand 1–positive (PD-L1–positive) tumors in the phase Ib open-label, multicohort KEYNOTE-028 (NCT02054806) study.

Patients and Methods: Patients with ER+/HER2− advanced breast cancer with PD-L1–positive tumors (combined positive score ≥1) received pembrolizumab (10 mg/kg every 2 weeks) up to 2 years or until confirmed progression/intolerable toxicity. Primary endpoints were safety and overall response rate (ORR), based on Response Evaluation Criteria in Solid Tumors, version 1 (RECIST v1.1) as assessed by investigator review.

Results: Between April 2014 and January 2015, 25 patients were enrolled. Median number of prior therapies for breast cancer, including endocrine agents, was 9 (range, 3–15). Median follow-up was 9.7 months (range, 0.7–31.8 months). Three patients experienced partial response (PR) and none experienced complete response (CR), resulting in an ORR of 12.0% (95% CI, 2.5%–31.2%); 16% of patients had stable disease (SD) and clinical benefit rate (CR + PR + [SD for ≥24 weeks]) was 20% (95% CI, 7–41). Median duration of response was 12.0 months (range, 7.4–15.9 months). The incidence of treatment-related adverse events was 64%; nausea (20%) and fatigue (12%) were most common and were predominantly grade 1/2. No treatment-related discontinuations or deaths occurred.

Conclusions: Pembrolizumab was well tolerated with modest but durable overall response in certain patients with previously treated, advanced, PD-L1–positive, ER+/HER2− breast cancer. Clin Cancer Res; 24(12); 2804–11. ©2018 AACR.

Footnotes

  • Note: Supplementary data for this article are available at Clinical Cancer Research Online (http://clincancerres.aacrjournals.org/).

  • Clinical trial registration: ClincalTrials.gov, NCT02054806.

  • Previous publication: Presented in part at the San Antonio Breast Cancer Symposium (SABCS) in San Antonio, Texas, on December 11, 2015: Rugo HS et al., Preliminary efficacy and safety of pembrolizumab (MK-3475) in patients with PD-L1–positive, estrogen receptor-positive (ER+)/HER2-negative advanced breast cancer enrolled in KEYNOTE-028.

  • Received November 21, 2017.
  • Revision received February 26, 2018.
  • Accepted March 15, 2018.
  • Published first March 20, 2018.
  • ©2018 American Association for Cancer Research.
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Clinical Cancer Research: 24 (12)
June 2018
Volume 24, Issue 12
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Safety and Antitumor Activity of Pembrolizumab in Patients with Estrogen Receptor–Positive/Human Epidermal Growth Factor Receptor 2–Negative Advanced Breast Cancer
Hope S. Rugo, Jean-Pierre Delord, Seock-Ah Im, Patrick A. Ott, Sarina A. Piha-Paul, Philippe L. Bedard, Jasgit Sachdev, Christophe Le Tourneau, Emilie M.J. van Brummelen, Andrea Varga, Roberto Salgado, Sherene Loi, Sanatan Saraf, Dina Pietrangelo, Vassiliki Karantza and Antoinette R. Tan
Clin Cancer Res June 15 2018 (24) (12) 2804-2811; DOI: 10.1158/1078-0432.CCR-17-3452

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Safety and Antitumor Activity of Pembrolizumab in Patients with Estrogen Receptor–Positive/Human Epidermal Growth Factor Receptor 2–Negative Advanced Breast Cancer
Hope S. Rugo, Jean-Pierre Delord, Seock-Ah Im, Patrick A. Ott, Sarina A. Piha-Paul, Philippe L. Bedard, Jasgit Sachdev, Christophe Le Tourneau, Emilie M.J. van Brummelen, Andrea Varga, Roberto Salgado, Sherene Loi, Sanatan Saraf, Dina Pietrangelo, Vassiliki Karantza and Antoinette R. Tan
Clin Cancer Res June 15 2018 (24) (12) 2804-2811; DOI: 10.1158/1078-0432.CCR-17-3452
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