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Meric-Bernstam, Funda; Sweis, Randy F; Kasper, Stefan; Hamid, Omid; Bhatia, Shailender; Dummer, Reinhard; Stradella, Agostina; Long, Georgina V; Spreafico, Anna; Shimizu, Toshio; Steeghs, Neeltje; Luke, Jason J; McWhirter, Sarah M; Müller, Thomas; Nair, Nitya; Lewis, Nancy; Chen, Xinhui; Bean, Andrew; Kattenhorn, Lisa; Pelletier, Marc; Sandhu, Shahneen
Clinical cancer research, 01/2023, Volume: 29, Issue: 1Journal Article
The stimulator of IFN genes (STING) is a transmembrane protein that plays a role in the immune response to tumors. Single-agent STING agonist MIW815 (ADU-S100) has demonstrated immune activation but limited antitumor activity. This phase Ib, multicenter, dose-escalation study assessed the safety and tolerability of MIW815 plus spartalizumab (PDR001), a humanized IgG4 antibody against PD-1, in 106 patients with advanced solid tumors or lymphomas. Patients were treated with weekly intratumoral injections of MIW815 (50-3,200 μg) on a 3-weeks-on/1-week-off schedule or once every 4 weeks, plus a fixed dose of spartalizumab (400 mg) intravenously every 4 weeks. Common adverse events were pyrexia (n = 23; 22%), injection site pain (n = 21; 20%), and diarrhea (n = 12; 11%). Overall response rate was 10.4%. The MTD was not reached. Pharmacodynamic biomarker analysis demonstrated on-target activity. The combination of MIW815 and spartalizumab was well tolerated in patients with advanced/metastatic cancers, including in patients with anti-PD-1 refractory disease. Minimal antitumor responses were seen.
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