{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,17]],"date-time":"2026-06-17T16:10:18Z","timestamp":1781712618227,"version":"3.54.5"},"reference-count":32,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2023,3,3]],"date-time":"2023-03-03T00:00:00Z","timestamp":1677801600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004339","name":"Sanofi","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004339","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cancer Medicine"],"published-print":{"date-parts":[[2023,5]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Given the incurable nature of multiple myeloma (MM), efforts are made to improve the efficacy of anti\u2010CD38 monoclonal antibodies via combinations with other potentially synergistic therapies. This Phase 1\/2 trial (NCT03194867) was designed to determine whether cemiplimab (anti\u2010PD\u20101) enhances the anti\u2010myeloma activity of isatuximab (anti\u2010CD38) in patients with relapsed and refractory multiple myeloma (RRMM), to confirm the feasibility of the combination, determine its efficacy, and further evaluate its safety.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Patients received isatuximab 10\u00a0mg\/kg once weekly for 4\u2009weeks followed by every 2\u2009weeks (Isa), or isatuximab 10\u00a0mg\/kg plus cemiplimab 250\u2009mg every 2 (Isa\u2009+\u2009CemiQ2W) or every 4\u2009weeks (Isa\u2009+\u2009CemiQ4W).<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Overall, 106 patients with RRMM treated with a median of 4 prior lines were included; 25.5% had high\u2010risk cytogenetics, 63.2% were refractory to proteasome inhibitors and immunomodulatory agents, 26.4% were previously exposed to daratumumab, and 84.0% were refractory to their last treatment line. There were no major changes in the safety or pharmacokinetic profile of isatuximab with the addition of cemiplimab. As assessed by investigators, four patients (11.8%) in the Isa arm, nine patients (25.0%) in the Isa\u2009+\u2009CemiQ2W arm, and eight patients (22.2%) in the Isa\u2009+\u2009CemiQ4W arm were responders. Though response rates were numerically higher in cemiplimab\u2010containing arms, differences were not statistically significant and did not translate to improved progression\u2010free or overall survival after a median follow\u2010up of 9.99\u2009months.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Our results suggest a marginal benefit by adding cemiplimab to isatuximab, despite demonstration of target engagement, without additional observed safety issues.<\/jats:p><\/jats:sec>","DOI":"10.1002\/cam4.5753","type":"journal-article","created":{"date-parts":[[2023,3,3]],"date-time":"2023-03-03T12:01:09Z","timestamp":1677844869000},"page":"10254-10266","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":13,"title":["Isatuximab in combination with cemiplimab in patients with relapsed\/refractory multiple myeloma: A phase 1\/2 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