阿替唑单抗
医学
内科学
队列
髓系白血病
不利影响
髓样
胃肠病学
临床研究阶段
肿瘤科
临床试验
癌症
免疫疗法
彭布罗利珠单抗
作者
Thomas Prebet,Aaron D Goldberg,Joseph G. Jurcic,Samer K. Khaled,Monique Dail,Yu-ning Feng,Cherie Green,Chunze Li,Connie Ma,Bruno C. Medeiros,Mark Yan,Michael R. Grunwald
标识
DOI:10.1080/10428194.2022.2057484
摘要
This phase 1 b study evaluated the safety, efficacy, and pharmacokinetics of atezolizumab in combination with guadecitabine in patients with relapsed/refractory (R/R) or first-line acute myeloid leukemia (AML). Patients received atezolizumab 840 mg (days [D] 8 and 22) and guadecitabine 60 mg/m2 (D1 and D5) over 28-day cycles. Sixteen patients (median age 73.0 years) enrolled (R/R cohort, n = 11; first-line cohort, n = 5). All patients reported at least 1 AE; 15 patients (93.8%) reported grade ≥ 3 AEs, and 15 patients (93.8%) reported SAEs. Fourteen of the 16 patients (87.5%) died during the trial period due to disease progression (8/14) or AEs (6/14), hence the study was terminated early. One patient (from the R/R AML cohort) achieved a response (CR with incomplete platelet recovery) with a DOR of 27.8 months at study termination. Atezolizumab plus guadecitabine had limited clinical activity in AML and an overall unfavorable benefit-risk profile at the investigated dose levels.
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