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Clinical Trials: Immunotherapy

Immunomodulatory Activity of a Colony-stimulating Factor-1 Receptor Inhibitor in Patients with Advanced Refractory Breast or Prostate Cancer: A Phase I Study

Karen A. Autio, Christopher A. Klebanoff, David Schaer, John Sae Wook Kauh, Susan F. Slovin, Matthew Adamow, Victoria S. Blinder, Manisha Brahmachary, Michelle Carlsen, Elizabeth Comen, Daniel C. Danila, Thompson N. Doman, Jeremy C. Durack, Josef J. Fox, Jill S. Gluskin, David M. Hoffman, Suhyun Kang, Praneet Kang, Jonathan Landa, Philomena F. McAndrew, Shanu Modi, Michael J. Morris, Ruslan Novosiadly, Dana E. Rathkopf, Rachel Sanford, Sonya C. Chapman, Courtney M. Tate, Danni Yu, Phillip Wong and Heather L. McArthur
Karen A. Autio
1Memorial Sloan Kettering Cancer Center, New York, New York.
2Weill Cornell Medical College, New York, New York.
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  • For correspondence: autiok@mskcc.org
Christopher A. Klebanoff
1Memorial Sloan Kettering Cancer Center, New York, New York.
2Weill Cornell Medical College, New York, New York.
3Parker Institute for Cancer Immunotherapy, New York, New York.
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David Schaer
4Pfizer WRD, Pearl River, New York.
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John Sae Wook Kauh
5Hutchison MediPharma International (US) Inc., Florham Park, New Jersey.
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  • ORCID record for John Sae Wook Kauh
Susan F. Slovin
1Memorial Sloan Kettering Cancer Center, New York, New York.
2Weill Cornell Medical College, New York, New York.
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Matthew Adamow
1Memorial Sloan Kettering Cancer Center, New York, New York.
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  • ORCID record for Matthew Adamow
Victoria S. Blinder
1Memorial Sloan Kettering Cancer Center, New York, New York.
2Weill Cornell Medical College, New York, New York.
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Manisha Brahmachary
6Eli Lilly and Company, New York, New York.
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Michelle Carlsen
7Eli Lilly and Company, Indianapolis, Indiana.
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Elizabeth Comen
1Memorial Sloan Kettering Cancer Center, New York, New York.
2Weill Cornell Medical College, New York, New York.
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Daniel C. Danila
1Memorial Sloan Kettering Cancer Center, New York, New York.
2Weill Cornell Medical College, New York, New York.
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Thompson N. Doman
7Eli Lilly and Company, Indianapolis, Indiana.
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Jeremy C. Durack
1Memorial Sloan Kettering Cancer Center, New York, New York.
2Weill Cornell Medical College, New York, New York.
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Josef J. Fox
1Memorial Sloan Kettering Cancer Center, New York, New York.
2Weill Cornell Medical College, New York, New York.
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Jill S. Gluskin
1Memorial Sloan Kettering Cancer Center, New York, New York.
2Weill Cornell Medical College, New York, New York.
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David M. Hoffman
8Cedars-Sinai Medical Center, Los Angeles, California.
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Suhyun Kang
7Eli Lilly and Company, Indianapolis, Indiana.
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Praneet Kang
1Memorial Sloan Kettering Cancer Center, New York, New York.
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Jonathan Landa
1Memorial Sloan Kettering Cancer Center, New York, New York.
2Weill Cornell Medical College, New York, New York.
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Philomena F. McAndrew
8Cedars-Sinai Medical Center, Los Angeles, California.
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Shanu Modi
1Memorial Sloan Kettering Cancer Center, New York, New York.
2Weill Cornell Medical College, New York, New York.
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Michael J. Morris
1Memorial Sloan Kettering Cancer Center, New York, New York.
2Weill Cornell Medical College, New York, New York.
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Ruslan Novosiadly
6Eli Lilly and Company, New York, New York.
9Bristol-Myers Squibb, Princeton, New Jersey.
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Dana E. Rathkopf
1Memorial Sloan Kettering Cancer Center, New York, New York.
2Weill Cornell Medical College, New York, New York.
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Rachel Sanford
1Memorial Sloan Kettering Cancer Center, New York, New York.
2Weill Cornell Medical College, New York, New York.
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Sonya C. Chapman
10Eli Lilly and Company, Windlesham, United Kingdom.
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Courtney M. Tate
7Eli Lilly and Company, Indianapolis, Indiana.
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Danni Yu
7Eli Lilly and Company, Indianapolis, Indiana.
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Phillip Wong
1Memorial Sloan Kettering Cancer Center, New York, New York.
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Heather L. McArthur
8Cedars-Sinai Medical Center, Los Angeles, California.
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DOI: 10.1158/1078-0432.CCR-20-0855 Published November 2020
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Abstract

Purpose: Tumor-associated macrophages correlate with increased invasiveness, growth, and immunosuppression. Activation of the colony-stimulating factor-1 receptor (CSF-1R) results in proliferation, differentiation, and migration of monocytes/macrophages. This phase I study evaluated the immunologic and clinical activity, and safety profile of CSF-1R inhibition with the mAb LY3022855.

Patients and Methods: Patients with advanced refractory metastatic breast cancer (MBC) or metastatic castration-resistant prostate cancer (mCRPC) were treated with LY3022855 intravenously in 6-week cycles in cohorts: (A) 1.25 mg/kg every 2 weeks (Q2W); (B) 1.0 mg/kg on weeks 1, 2, 4, and 5; (C) 100 mg once weekly; (D)100 mg Q2W. mCRPC patients were enrolled in cohorts A and B; patients with MBC were enrolled in all cohorts. Efficacy was assessed by RECIST and Prostate Cancer Clinical Trials Working Group 2 criteria.

Results: Thirty-four patients (22 MBC; 12 mCRPC) received ≥1 dose of LY3022855. At day 8, circulating CSF-1 levels increased and proinflammatory monocytes CD14DIMCD16BRIGHT decreased. Best RECIST response was stable disease in five patients with MBC (23%; duration, 82–302 days) and three patients with mCRPC (25%; duration, 50–124 days). Two patients with MBC (cohort A) had durable stable disease >9 months and a third patient with MBC had palpable reduction in a nontarget neck mass. Immune-related gene activation in tumor biopsies posttreatment was observed. Common any grade treatment-related adverse events were fatigue, decreased appetite, nausea, asymptomatic increased lipase, and creatine phosphokinase.

Conclusions: LY3022855 was well tolerated and showed evidence of immune modulation. Clinically meaningful stable disease >9 months was observed in two patients with MBC.

Footnotes

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

  • Clinicaltrials.gov registration ID: NCT02265536.

  • Clin Cancer Res 2020;26:5609–20

  • Received March 8, 2020.
  • Revision received July 2, 2020.
  • Accepted August 20, 2020.
  • Published first August 26, 2020.
  • ©2020 American Association for Cancer Research.
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Clinical Cancer Research: 26 (21)
November 2020
Volume 26, Issue 21
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Immunomodulatory Activity of a Colony-stimulating Factor-1 Receptor Inhibitor in Patients with Advanced Refractory Breast or Prostate Cancer: A Phase I Study
Karen A. Autio, Christopher A. Klebanoff, David Schaer, John Sae Wook Kauh, Susan F. Slovin, Matthew Adamow, Victoria S. Blinder, Manisha Brahmachary, Michelle Carlsen, Elizabeth Comen, Daniel C. Danila, Thompson N. Doman, Jeremy C. Durack, Josef J. Fox, Jill S. Gluskin, David M. Hoffman, Suhyun Kang, Praneet Kang, Jonathan Landa, Philomena F. McAndrew, Shanu Modi, Michael J. Morris, Ruslan Novosiadly, Dana E. Rathkopf, Rachel Sanford, Sonya C. Chapman, Courtney M. Tate, Danni Yu, Phillip Wong and Heather L. McArthur
Clin Cancer Res November 1 2020 (26) (21) 5609-5620; DOI: 10.1158/1078-0432.CCR-20-0855

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Immunomodulatory Activity of a Colony-stimulating Factor-1 Receptor Inhibitor in Patients with Advanced Refractory Breast or Prostate Cancer: A Phase I Study
Karen A. Autio, Christopher A. Klebanoff, David Schaer, John Sae Wook Kauh, Susan F. Slovin, Matthew Adamow, Victoria S. Blinder, Manisha Brahmachary, Michelle Carlsen, Elizabeth Comen, Daniel C. Danila, Thompson N. Doman, Jeremy C. Durack, Josef J. Fox, Jill S. Gluskin, David M. Hoffman, Suhyun Kang, Praneet Kang, Jonathan Landa, Philomena F. McAndrew, Shanu Modi, Michael J. Morris, Ruslan Novosiadly, Dana E. Rathkopf, Rachel Sanford, Sonya C. Chapman, Courtney M. Tate, Danni Yu, Phillip Wong and Heather L. McArthur
Clin Cancer Res November 1 2020 (26) (21) 5609-5620; DOI: 10.1158/1078-0432.CCR-20-0855
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