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Geurts, V.C.M.; Voorwerk, L.; Balduzzi, S.; Salgado, R.; Van de Vijver, K.; van Dongen, M.G.J.; Kemper, I.; Mandjes, I.A.M.; Heuver, M.; Sparreboom, W.; Haanen, J.B.A.G.; Sonke, G.S.; Horlings, H.M.; Kok, M.
Breast (Edinburgh), 08/2023, Volume: 70Journal Article
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. •The MIMOSA trial investigated the novel combination of monalizumab and trastuzumab for HER2+ MBC.•The novel combination was well-tolerated, but no clinical responses were observed.•Combination strategies are warranted to induce a more inflamed tumor microenvironment.•Enrichment of inflamed HER2+ MBC with high TIL is likely to increase response to ICB.
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