Data from Safety and Efficacy of Copanlisib in Combination with Nivolumab: A Phase Ib Study in Patients with Advanced Solid Tumors

• DOI: 10.1158/2767-9764.c.7719926
• Publication Date: 2025-03-14T10:20:35Z
• Authors: Benedito A. Carneiro; Robert M. Jotte; Nashat Y. Gabrail; Kristopher Wentzel; Funan Huang; Shalini Chaturvedi; Anke Weispfenning; Florian Hiemeyer; Peter N. Morcos; Lidia Mongay Soler; Barrett H. Childs; Aaron R. Hansen

<div>AbstractPurpose:<p>Copanlisib in combination with immune checkpoint inhibitors demonstrated synergy and favorable antitumor responses preclinical models. This study evaluated copanlisib plus nivolumab adults advanced solid tumors.</p>Patients Methods:<p>In this phase Ib, nonrandomized, open-label, dose-escalation study, patients received intravenous 240 mg (day 15 of cycle 1 days subsequent cycles) (45 or 60 on 1, 8, each cycle) 28-day cycles. The primary objective was to determine the MTD and/or recommended II dose nivolumab. Secondary objectives were safety, tolerability, efficacy. Exploratory included evaluation potentially predictive biomarkers.</p>Results:<p>Overall, 16 treated [copanlisib: 45 (<i>n</i> = 5); 11)]. most common cancer types at baseline bladder (25.0%) oropharyngeal (18.8%) cancers. No dose-limiting toxicities observed; deemed mg. Grade 3 4 treatment-emergent adverse events reported 56.3% 12.5% patients, respectively; one grade 5 event (unrelated treatment). Overall, 18.8% achieved a partial response. Evaluations potential biomarkers did not correlate response, but copanlisib-modulated biomarker changes observed before administration consistent dose-dependent.</p>Conclusions:<p>No new safety concerns identified combination, preliminary efficacy indicated an effect. Data supported immunomodulatory effect copanlisib, suggesting that may enhance inhibitors.</p>Significance:<p>The well tolerated showed effects tumors. number circulating myeloid-derived suppressive cells decreased 24 48 hours after treatment copanlisib. Further investigation is warranted as novel strategy inhibitors.</p></div>