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Poster Display session 2

4545 - Bintrafusp alfa (M7824) and Eribulin Mesylate in Treating Patients With Metastatic Triple Negative Breast Cancer (TNBC)(NCT03579472)

Date

29 Sep 2019

Session

Poster Display session 2

Topics

Tumour Site

Breast Cancer

Presenters

Jennifer Litton

Citation

Annals of Oncology (2019) 30 (suppl_5): v104-v142. 10.1093/annonc/mdz242

Authors

J.K. Litton1, S. Damodaran2, I.I. Wistuba3, F. Yang4, A. Contreras4, A. Tam5, L. Ojalvo6, I. Dussault7, C. Helwig8, S. Moulder1

Author affiliations

  • 1 Breast Medical Oncology, MD Anderson Cancer Center, 77030 - Houston/US
  • 2 Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, 77030 - Houston/US
  • 3 Pathology, The University of Texas MD Anderson Cancer Center, 77030-4095 - Houston/US
  • 4 Pathology, The University of Texas MD Anderson Cancer Center, 77030 - Houston/US
  • 5 Interventional Radiology, The University of Texas MD Anderson Cancer Center, 77030 - Houston/US
  • 6 Gcd, EMD Serono Research Center, 01821 - Billerica/US
  • 7 Clinical Biomarkers, EMD Serono Research Center, 01821 - Billerica/US
  • 8 Clinical Research, Merck KGaA - Germany, 64293 - Darmstadt/DE

Resources

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Abstract 4545

Background

TNBC is an aggressive subtype of metastatic breast cancer. Eribulin has been shown to have activity in metastatic TNBC and has enhanced efficacy if TGF-β is downregulated. Additionally, down-regulating TGF-β in the tumor microenvironment may decrease tumor growth and increase responsiveness to checkpoint blockade. Bintrafusp alfa* (M7824) is an innovative first-in-class bifunctional fusion protein composed of the extracellular domain of the TGF-βRII receptor (a TGF-β “trap”) fused to a human IgG1 mAb blocking PD-L1. Therefore the combination of eribulin with bintrafusp alfa is being tested in this phase I trial to evaluate safety and efficacy for patients with metastatic TNBC.

Trial design

This is an open-label, single arm phase Ib study in patients with metastatic TNBC. The primary objective is to evaluate the recommended phase-2 dosing of eribulin and bintrafusp. Patients undergo core tissue biopsy and blood work at enrollment. Patients will then receive study drug (bintrafusp alfa) and eribulin with tumor assessments at 6 and 12 weeks. Patients will be treated in a cohort size of 4 with an expansion of up to 20 patients. Bayesian optimal interval (BOIN) design will be employed to identify the RP2D of eribulin by conducting dose de-escalations based on dose-limiting toxicity. Patients undergo repeat core tissue biopsy after 12 weeks of therapy and will continue on study drug until progression of disease or a sustained CR for one year. Eligibility: Inclusion: metastatic TNBC, adequate organ, bone marrow and cardiac parameters. Exclusion: prior immunotherapy, IBC, history of autoimmune disease, HIV, Hep-B, Hep-C, active tuberculosis, pregnant. PD-L1 positivity is not an eligibility requirement. CORRELATIVE SCIENCE: Biopsies and blood are being obtained at baseline and after 2 months of therapy as well as requested at the time of progression of disease. Peripheral blood mononuclear cells (PBMCs will be evaluated for immunophenotyping, T cell activation and function as well as T cell repertoire analysis. PD-L1 staining will be done on tumor and infiltrating immune cells. From the tumor samples, TIL will be measured and characterized as well as tumor-tissue gene expression.

Clinical trial identification

NCT03579472.

Editorial acknowledgement

Legal entity responsible for the study

The University of Texas MD Anderson Cancer Center.

Funding

Merck/EMD-Serono.

Disclosure

J.K. Litton: Research grant / Funding (institution): astra zeneca; Advisory / Consultancy, uncompensated: astra zeneca; Advisory / Consultancy, uncompensated: Pfizer; Research grant / Funding (institution): Pfizer; Research grant / Funding (institution): EMD Serono; Research grant / Funding (institution): Novartis; Advisory / Consultancy, uncompensated: Genentech; Research grant / Funding (institution): Genentech. S. Damodaran: Research grant / Funding (institution): emd serono. I.I. Wistuba: Research grant / Funding (institution): emd serono. L. Ojalvo: Full / Part-time employment: emd serono. I. Dussault: Full / Part-time employment: emd serono. C. Helwig: Full / Part-time employment: Merck. All other authors have declared no conflicts of interest.

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