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Breast ; 70: 76-81, 2023 Aug.
Article in English | MEDLINE | ID: mdl-37393645

ABSTRACT

The large majority of patients with HER2-positive metastatic breast cancer (MBC) will eventually develop resistance to anti-HER2 therapy and die of this disease. Despite, relatively high levels of stromal tumor infiltrating lymphocytes (sTILs), PD1-blockade has only shown modest responses. Monalizumab targets the inhibitory immune checkpoint NKG2A, thereby unleashing NK- and CD8 T cells. We hypothesized that monalizumab synergizes with trastuzumab by promoting antibody-dependent cell-mediated cytotoxicity. In the phase II MIMOSA-trial, HER2-positive MBC patients were treated with trastuzumab and 750 mg monalizumab every two weeks. Following a Simon's two-stage design, 11 patients were included in stage I of the trial. Treatment was well tolerated with no dose-limiting toxicities. No objective responses were observed. Therefore, the MIMOSA-trial did not meet its primary endpoint. In summary, despite the strong preclinical rationale, the novel combination of monalizumab and trastuzumab does not induce objective responses in heavily pre-treated HER2-positive MBC patients.


Subject(s)
Breast Neoplasms , Mimosa , Female , Humans , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Breast Neoplasms/pathology , CD8-Positive T-Lymphocytes/pathology , Receptor, ErbB-2 , Trastuzumab/therapeutic use
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