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Poster display

1366 - METRIC: A randomized international study of the antibody drug conjugate (ADC) glembatumumab vedotin (GV, CDX-011) in patients (pts) with metastatic gpNMB overexpressing triple-negative breast cancer (TNBC)

Date

10 Oct 2016

Session

Poster display

Presenters

Peter Schmid

Citation

Annals of Oncology (2016) 27 (6): 68-99. 10.1093/annonc/mdw365

Authors

P. Schmid1, M. Melisko2, D.A. Yardley3, K. Blackwell4, A. Forero5, G. Ouellette6, Y. He7, R.G. Bagley8, J. Zhang8, L.T. Vahdat9

Author affiliations

  • 1 Centre For Experimental Cancer Medicine, Barts Cancer Institute-Queen Mary University of London, EC1M 6BQ - London/GB
  • 2 Department Of Medicine, UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco/US
  • 3 Breast Cancer Research Program, Sarah Cannon Research Institute/Tennessee Oncology, PLLC, Nashville/US
  • 4 Department Of Medicine, Duke University Medical Center, Durham/US
  • 5 Department Of Medicine, University of Alabama at Birmingham, Birmingham/US
  • 6 Clinical Operations, Celldex Therapeutics, Inc., Hampton/US
  • 7 Biostatistics, Celldex Therapeutics, Inc., Hampton/US
  • 8 Clinical Science, Celldex Therapeutics, Inc., Hampton/US
  • 9 Breast Cancer Research Program, Weill Cornell Medicine, New York/US
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Resources

Abstract 1366

Background

Glycoprotein NMB (gpNMB) is an internalizable transmembrane protein overexpressed in ∼20% of breast cancer (BC) including ∼40% of TNBC. gpNMB is a poor prognostic marker in BC (Rose CCR 2010) and implicated in tumor invasion, metastasis, and angiogenesis. GV is a novel ADC delivering the potent cytotoxin MMAE to gpNMB expressing cancer cells. In a Phase 1/2 study and in the Phase 2 EMERGE study, GV was well tolerated and demonstrated promising activity, particularly in TNBC and/or gpNMB overexpressing (≥25% tumor cells; gpNMB+) BC. GV toxicity included rash, neutropenia and neuropathy (primarily grade 1 and 2). In EMERGE subset analyses, objective response rate (ORR) for GV vs. investigator's choice chemotherapy = 30% (7/23) vs. 9% (1/11) in gpNMB+ BC; 18% (5/28) vs. 0% (0/11) in TNBC; and 40% (4/10) vs. 0% (0/6) in gpNMB+ TNBC. Improvements in PFS (hazard ratio (HR) = 0.11; 95% CI, 0.02 to 0.57) and OS (HR = 0.14; 95% CI, 0.03 to 0.59) were also apparent in gpNMB+ TNBC.

Trial design

The METRIC Trial (NCT#01997333) is an ongoing international, 2-arm Phase 2, registrational, TNBC study open in the USA, Canada, Australia, Spain and UK with sites planned in France, Germany and Italy. Pts are randomized 2:1 to GV (1.88 mg/kg IV q3w) or capecitabine (2,500 mg/m2 PO d1-14 q3w) until progression or intolerance. Eligibility Criteria Key eligibility criteria: ≥25% tumor epithelium gpNMB+ by central IHC screening; estrogen and progesterone receptors

Clinical trial identification

NCT #01997333; EudraCT #2015-003693-33

Legal entity responsible for the study

Celldex Therapeutics, Inc.

Funding

Celldex Therapeutics, Inc.

Disclosure

G. Ouellette, Y. He, J. Zhang: Full time employee of and stock ownership in Celldex Therapeutics, Inc.

R.G. Bagley: Full time employee of and stock ownership in Celldex Therapeutics, Inc. All other authors have declared no conflicts of interest.

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