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The DOI matches its Crossref record; 34 of the 34 references it cites were found in a registry or an index.

Avelumab, an anti-PD-L1 antibody, in patients with locally advanced or metastatic breast cancer: a phase 1b JAVELIN Solid Tumor study

Open access
Dirix, Luc Y., Takacs, Istvan, Jerusalem, Guy, Nikolinakos, Petros, Arkenau, Hendrik-Tobias, Forero-Torres, Andres, Boccia, Ralph, Lippman, Marc E., Somer, Robert, Smakal, Martin, Emens, Leisha A., Hrinczenko, Borys, Edenfield, William, Gurtler, Jayne, von Heydebreck, Anja, Grote, Hans Juergen, Chin, Kevin, Hamilton, Erika P.·2018·Breast Cancer Research and Treatment

Abstract

PURPOSE: Agents targeting programmed death receptor 1 (PD-1) or its ligand (PD-L1) have shown antitumor activity in the treatment of metastatic breast cancer (MBC). The aim of this study was to assess the activity of avelumab, a PD-L1 inhibitor, in patients with MBC. METHODS: In a phase 1 trial (JAVELIN Solid Tumor; NCT01772004), patients with MBC refractory to or progressing after standard-of-care therapy received avelumab intravenously 10 mg/kg every 2 weeks. Tumors were assessed every 6 weeks by RECIST v1.1. Adverse events (AEs) were graded by NCI-CTCAE v4.0. Membrane PD-L1 expression was assessed by immunohistochemistry (Dako PD-L1 IHC 73-10 pharmDx). RESULTS: A total of 168 patients with MBC, including 58 patients with triple-negative breast cancer (TNBC), were treated with avelumab for 2-50 weeks and followed for 6-15 months. Patients were heavily pretreated with a median of three prior therapies for metastatic or locally advanced disease. Grade ≥ 3 treatment-related AEs occurred in 13.7% of patients, including two treatment-related deaths. The confirmed objective response rate (ORR) was 3.0% overall (one complete response and four partial responses) and 5.2% in patients with TNBC. A trend toward a higher ORR was seen in patients with PD-L1+ versus PD-L1- tumor-associated immune cells in the overall population (16.7% vs. 1.6%) and in the TNBC subgroup (22.2% vs. 2.6%). CONCLUSION: Avelumab showed an acceptable safety profile and clinical activity in a subset of patients with MBC. PD-L1 expression in tumor-associated immune cells may be associated with a higher probability of clinical response to avelumab in MBC.

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Metadata

Authors
Dirix, L. Y., Takacs, I., Jerusalem, G., Nikolinakos, P., Arkenau, H.-T., Forero-Torres, A., Boccia, R., Lippman, M. E., Somer, R., Smakal, M., Emens, L. A., Hrinczenko, B., Edenfield, W., Gurtler, J., von Heydebreck, A., Grote, H. J., Chin, K., & Hamilton, E. P.
Venue
Breast Cancer Research and Treatment
Published
2017-10-23
Volume
167
Issue
3
Pages
671-686
ISSN
  • 0167-6806 (ISSN-L)
  • 1573-7217
OpenAlex
W2766673799
Cited by
746
References
34
FWCI
27.47
Type
journal article
Language
en
Open access
hybrid

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CoChat. (2026). Citation check: Avelumab, an anti-PD-L1 antibody, in patients with locally advanced or metastatic breast cancer: a phase 1b JAVELIN Solid Tumor study. https://app.cochat.ai/papers/10.1007/s10549-017-4537-5
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Dirix, L. Y., Takacs, I., Jerusalem, G., Nikolinakos, P., Arkenau, H.-T., Forero-Torres, A., Boccia, R., Lippman, M. E., Somer, R., Smakal, M., Emens, L. A., Hrinczenko, B., Edenfield, W., Gurtler, J., von Heydebreck, A., Grote, H. J., Chin, K., & Hamilton, E. P. (2018). Avelumab, an anti-PD-L1 antibody, in patients with locally advanced or metastatic breast cancer: a phase 1b JAVELIN Solid Tumor study. Breast Cancer Research and Treatment. https://doi.org/10.1007/s10549-017-4537-5

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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

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