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Clinical Trials: Immunotherapy

Results of a Randomized Phase IIb Trial of Nelipepimut-S + Trastuzumab versus Trastuzumab to Prevent Recurrences in Patients with High-Risk HER2 Low-Expressing Breast Cancer

G. Travis Clifton, Diane Hale, Timothy J. Vreeland, Annelies T. Hickerson, Jennifer K. Litton, Gheath Alatrash, Rashmi K. Murthy, Na Qiao, Anne V. Philips, Jason J. Lukas, Jarrod P. Holmes, George E. Peoples and Elizabeth A. Mittendorf
G. Travis Clifton
1Department of Surgery, Brooke Army Medical Center, Fort Sam Houston, San Antonio, Texas.
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Diane Hale
1Department of Surgery, Brooke Army Medical Center, Fort Sam Houston, San Antonio, Texas.
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Timothy J. Vreeland
2Department of Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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Annelies T. Hickerson
1Department of Surgery, Brooke Army Medical Center, Fort Sam Houston, San Antonio, Texas.
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Jennifer K. Litton
3Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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Gheath Alatrash
4Department of Stem Cell Transplantation and Cellular Therapy, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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Rashmi K. Murthy
3Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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Na Qiao
5Department of Breast Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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Anne V. Philips
5Department of Breast Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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Jason J. Lukas
6Division of Oncology, Department of Medicine, University of Washington, Seattle Cancer Care Alliance, Issaquah, Washington.
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Jarrod P. Holmes
7Department of Medical Oncology, St. Joseph Health Cancer Center, Santa Rosa, California.
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George E. Peoples
8Department of Surgery, Uniformed Services Health University, Bethesda, Maryland.
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  • For correspondence: emittendorf@bwh.harvard.edu gpeoples@cancerinsight.com
Elizabeth A. Mittendorf
5Department of Breast Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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  • For correspondence: emittendorf@bwh.harvard.edu gpeoples@cancerinsight.com
DOI: 10.1158/1078-0432.CCR-19-2741 Published June 2020
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Abstract

Purpose: Preclinical data provide evidence for synergism between HER2-targeted peptide vaccines and trastuzumab. The efficacy of this combination was evaluated in patients with HER2 low-expressing breast cancer in the adjuvant setting.

Patients and Methods: A phase IIb, multicenter, randomized, single-blinded, controlled trial enrolled disease-free patients after standard therapy completion (NCT01570036). Eligible patients were HLA-A2, A3, A24, and/or A26+, and had HER2 IHC 1+/2+, FISH nonamplified breast cancer, that was node positive and/or hormone receptor–negative [triple-negative breast cancer (TNBC)]. Patients received trastuzumab for 1 year and were randomized to placebo (GM-CSF, control) or nelipepimut-S (NPS) with GM-CSF. Primary outcome was 24-month disease-free survival (DFS). Secondary outcomes were 36-month DFS, safety, and immunologic response.

Results: Overall, 275 patients were randomized; 136 received NPS with GM-CSF, and 139 received placebo with GM-CSF. There were no clinicopathologic differences between groups. Concurrent trastuzumab and NPS with GM-CSF was safe with no additional overall or cardiac toxicity compared with control. At median follow-up of 25.7 (interquartile range, 18.4–32.7) months, estimated DFS did not significantly differ between NPS and control [HR, 0.62; 95% confidence interval (CI), 0.31–1.25; P = 0.18]. In a planned exploratory analysis of patients with TNBC, DFS was improved for NPS versus control (HR, 0.26; 95% CI, 0.08–0.81, P = 0.01).

Conclusions: The combination of NPS with trastuzumab is safe. In HER2 low-expressing breast cancer, no significant difference in DFS was seen in the intention-to-treat analysis; however, significant clinical benefit was seen in patients with TNBC. These findings warrant further investigation in a phase III randomized trial.

Footnotes

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

  • Clin Cancer Res 2020;26:2515–23

  • Received September 30, 2019.
  • Revision received December 20, 2019.
  • Accepted February 14, 2020.
  • Published first February 18, 2020.
  • ©2020 American Association for Cancer Research.
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Clinical Cancer Research: 26 (11)
June 2020
Volume 26, Issue 11
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Results of a Randomized Phase IIb Trial of Nelipepimut-S + Trastuzumab versus Trastuzumab to Prevent Recurrences in Patients with High-Risk HER2 Low-Expressing Breast Cancer
G. Travis Clifton, Diane Hale, Timothy J. Vreeland, Annelies T. Hickerson, Jennifer K. Litton, Gheath Alatrash, Rashmi K. Murthy, Na Qiao, Anne V. Philips, Jason J. Lukas, Jarrod P. Holmes, George E. Peoples and Elizabeth A. Mittendorf
Clin Cancer Res June 1 2020 (26) (11) 2515-2523; DOI: 10.1158/1078-0432.CCR-19-2741

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Results of a Randomized Phase IIb Trial of Nelipepimut-S + Trastuzumab versus Trastuzumab to Prevent Recurrences in Patients with High-Risk HER2 Low-Expressing Breast Cancer
G. Travis Clifton, Diane Hale, Timothy J. Vreeland, Annelies T. Hickerson, Jennifer K. Litton, Gheath Alatrash, Rashmi K. Murthy, Na Qiao, Anne V. Philips, Jason J. Lukas, Jarrod P. Holmes, George E. Peoples and Elizabeth A. Mittendorf
Clin Cancer Res June 1 2020 (26) (11) 2515-2523; DOI: 10.1158/1078-0432.CCR-19-2741
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