Title |
Avelumab, an anti-PD-L1 antibody, in patients with locally advanced or metastatic breast cancer: a phase 1b JAVELIN Solid Tumor study
|
---|---|
Published in |
Breast Cancer Research and Treatment, October 2017
|
DOI | 10.1007/s10549-017-4537-5 |
Pubmed ID | |
Authors |
Luc Y. Dirix, Istvan Takacs, Guy Jerusalem, Petros Nikolinakos, Hendrik-Tobias Arkenau, Andres Forero-Torres, Ralph Boccia, Marc E. Lippman, Robert Somer, Martin Smakal, Leisha A. Emens, Borys Hrinczenko, William Edenfield, Jayne Gurtler, Anja von Heydebreck, Hans Juergen Grote, Kevin Chin, Erika P. Hamilton |
Abstract |
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. 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). 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%). 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. |
X Demographics
Geographical breakdown
Country | Count | As % |
---|---|---|
France | 1 | 33% |
Unknown | 2 | 67% |
Demographic breakdown
Type | Count | As % |
---|---|---|
Members of the public | 3 | 100% |
Mendeley readers
Geographical breakdown
Country | Count | As % |
---|---|---|
Unknown | 499 | 100% |
Demographic breakdown
Readers by professional status | Count | As % |
---|---|---|
Student > Bachelor | 57 | 11% |
Student > Ph. D. Student | 56 | 11% |
Researcher | 48 | 10% |
Student > Master | 46 | 9% |
Other | 30 | 6% |
Other | 99 | 20% |
Unknown | 163 | 33% |
Readers by discipline | Count | As % |
---|---|---|
Medicine and Dentistry | 136 | 27% |
Biochemistry, Genetics and Molecular Biology | 53 | 11% |
Pharmacology, Toxicology and Pharmaceutical Science | 24 | 5% |
Agricultural and Biological Sciences | 23 | 5% |
Immunology and Microbiology | 21 | 4% |
Other | 58 | 12% |
Unknown | 184 | 37% |